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Trial record 37 of 108 for:    Risedronate

Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

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ClinicalTrials.gov Identifier: NCT00343252
Recruitment Status : Completed
First Posted : June 22, 2006
Results First Posted : July 12, 2010
Last Update Posted : May 26, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Osteoporosis, Postmenopausal
Back Pain
Spinal Fracture
Interventions Drug: teriparatide
Drug: risedronate
Drug: placebo
Enrollment 712
Recruitment Details  
Pre-assignment Details 712 participants were randomized: 361 to teriparatide; 351 to risedronate. 2 participants did not receive drug. Only randomized participants who received at least 1 dose of drug were analyzed. At 18 months, reason for discontinuation was corrected from sponsor decision to entry criteria not met (1) and protocol violation (1) for 2 participants.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Period Title: All Randomized Participants
Started 361 351
Completed 259 269
Not Completed 102 82
Period Title: 6 Months (All Treated Participants)
Started 360 [1] 350 [2]
Completed 304 306
Not Completed 56 44
Reason Not Completed
Adverse Event             17             11
Death             0             2
Entry Criteria Not Met             10             8
Lack of Efficacy             0             1
Lost to Follow-up             0             4
Physician Decision             1             3
Protocol Violation             2             2
Sponsor Decision             7             4
Withdrawal by Subject             19             9
[1]
361 participants were randomized but 1 did not receive study drug and was not analyzed.
[2]
351 participants were randomized but 1 did not receive study drug and was not analyzed.
Period Title: 12 Months (All Treated Participants)
Started 360 [1] 350 [2]
Completed 274 [3] 281 [3]
Not Completed 86 69
Reason Not Completed
Adverse Event             22             20
Death             3             3
Entry Criteria Not Met             10             10
Lack of Efficacy             1             1
Lost to Follow-up             1             5
Physician Decision             4             5
Protocol Violation             3             2
Sponsor Decision             9             6
Withdrawal by Subject             33             17
[1]
361 participants were randomized but 1 did not receive study drug and was not analyzed.
[2]
351 participants were randomized but 1 did not receive study drug and was not analyzed.
[3]
Completed 12 Months.
Period Title: 18 Months (All Treated Participants)
Started 360 350
Completed 259 269
Not Completed 101 81
Reason Not Completed
Adverse Event             31             23
Death             4             5
Entry Criteria Not Met             11             10
Lack of Efficacy             1             1
Lost to Follow-up             3             7
Physician Decision             4             7
Protocol Violation             3             3
Sponsor Decision             8             5
Withdrawal by Subject             36             20
Arm/Group Title Teriparatide Risedronate Total
Hide Arm/Group Description Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo Total of all reporting groups
Overall Number of Baseline Participants 360 350 710
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 360 participants 350 participants 710 participants
70.54  (8.80) 71.55  (8.12) 71.04  (8.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 360 participants 350 participants 710 participants
Female
360
 100.0%
350
 100.0%
710
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 360 participants 350 participants 710 participants
Hispanic 67 61 128
African Descent 2 3 5
Caucasian 285 286 571
East Asian 3 0 3
Native American 3 0 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 360 participants 350 participants 710 participants
United States 50 48 98
Argentina 38 42 80
Australia 30 30 60
Belgium 7 6 13
Brazil 30 30 60
Canada 54 55 109
France 13 10 23
Italy 22 20 42
Mexico 23 23 46
Puerto Rico 12 10 22
Spain 32 32 64
Sweden 13 10 23
Germany 36 34 70
Number of Vertebral Fractures   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 360 participants 350 participants 710 participants
Unknown or No Vertebral Fractures 37 35 72
1 Vertebral Fracture 126 104 230
>=2 Vertebral Fractures 197 211 408
[1]
Measure Description: A minimum of at least one moderate osteoporotic vertebral fracture was radiologically detected and vertebral fracture status was documented. A moderate vertebral fracture was defined as at least a 25% decrease in anterior, central, or posterior vertebral height (T4 to L4) as compared to the average height of adjacent vertebrae. This measure categorizes the number of vertebral fractures for each participant.
Prior Osteoporosis Drug Use   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 360 participants 350 participants 710 participants
Yes 267 258 525
No 93 92 185
[1]
Measure Description: Participants answered yes or no regarding use of osteoporosis drugs prior to this study.
Severity of Vertebral Fracture   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 360 participants 350 participants 710 participants
Zero or Mild Severity (Grade 0) 50 46 96
Moderate Severity (Grade 2) 160 166 326
Severe (Grade 3) 142 131 273
Unknown or Not Reported 8 7 15
[1]
Measure Description: An experienced radiologist graded all vertebrae by visual inspection from normal (grade 0) to severely deformed (grade 3).
Spinal Deformity Index   [1] 
Measure Type: Number
Unit of measure:  Units on a scale
Number Analyzed 360 participants 350 participants 710 participants
0 29 28 57
1 11 16 27
2 76 67 143
>=3 236 232 468
Unknown or Not Reported 8 7 15
[1]
Measure Description: Spinal deformity index is the summation of the severity of the vertebral fracture(s).
24-Hour Average Back Pain Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 360 participants 350 participants 710 participants
5.34  (1.86) 5.40  (1.85) 5.37  (1.85)
[1]
Measure Description: 24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the specified last observation carried forward (LOCF) endpoint.
24-Hour Worst Back Pain Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 360 participants 350 participants 710 participants
6.80  (1.63) 6.91  (1.54) 6.85  (1.59)
[1]
Measure Description: 24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms/meters squared
Number Analyzed 360 participants 350 participants 710 participants
26.30  (5.01) 26.36  (4.91) 26.33  (4.96)
[1]
Measure Description: Body mass index is an estimate of body fat based on body weight divided by height squared.
Duration of Back Pain  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 360 participants 350 participants 710 participants
550.33  (918.18) 550.88  (750.47) 550.58  (842.78)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 360 participants 350 participants 710 participants
154.82  (7.41) 153.62  (7.86) 154.23  (7.66)
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 360 participants 350 participants 710 participants
47.08  (14.61) 46.98  (14.39) 47.03  (14.49)
[1]
Measure Description: QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Roland-Morris Disability Questionnaire Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 360 participants 350 participants 710 participants
11.88  (5.47) 12.12  (5.40) 12.00  (5.44)
[1]
Measure Description: Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked is added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 360 participants 350 participants 710 participants
63.02  (12.70) 62.27  (12.58) 62.65  (12.63)
1.Primary Outcome
Title Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
Hide Description 24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 348 336
Measure Type: Number
Unit of Measure: participants
Responder to Treatment 206 193
Non-Responder to Treatment 142 143
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.642
Comments All comparisons were conducted using a 2-sided significance level of 0.05.
Method Chi-square
Comments No adjustments for multiplicity were performed.
2.Secondary Outcome
Title Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
Hide Description 24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 348 336
Measure Type: Number
Unit of Measure: participants
Responder to Treatment 233 220
Non-Responder to Treatment 115 116
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline at the 12-month endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.683
Comments All comparisons were conducted using a 2-sided significance level of 0.05.
Method Chi-square
Comments No adjustments for multiplicity were performed.
3.Secondary Outcome
Title Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint
Hide Description 24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 347 336
Measure Type: Number
Unit of Measure: participants
Responder to Treatment 221 211
Non-Responder to Treatment 126 125
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.809
Comments All comparisons were conducted using a 2-sided significance level of 0.05.
Method Chi-square
Comments No adjustments for multiplicity were performed.
4.Secondary Outcome
Title Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint
Hide Description 24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 347 336
Measure Type: Number
Unit of Measure: participants
Responder to Treatment 246 238
Non-Responder to Treatment 101 98
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.986
Comments All comparisons were conducted using a 2-sided significance level of 0.05.
Method Chi-square
Comments No adjustments for multiplicity were performed.
5.Secondary Outcome
Title Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Hide Description Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 6 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
Time Frame Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
Hide Outcome Measure Data
Hide Analysis Population Description
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 348 336
Measure Type: Number
Unit of Measure: participants
Day 0 0 0
Day 30 26 22
Day 60 70 74
Day 90 110 111
Day 120 151 145
Day 150 175 164
Day 180 195 181
Day 210 206 192
Day 240 206 193
Day 270 206 193
Day 300 206 193
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a >=30% reduction in worst back pain at the 6-month endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.746
Comments Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.
Method Log Rank
Comments No adjustments for multiplicity were performed.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.85 to 1.26
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Hide Description Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 12 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
Time Frame Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
Hide Outcome Measure Data
Hide Analysis Population Description
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 348 336
Measure Type: Number
Unit of Measure: participants
Day 0 0 0
Day 60 70 74
Day 120 151 145
Day 180 195 181
Day 240 206 193
Day 300 224 206
Day 360 226 209
Day 420 233 220
Day 480 233 220
Day 540 233 220
Day 600 233 220
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a >=30% reduction in worst back pain at the 12-month endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.719
Comments Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.
Method Log Rank
Comments No adjustments for multiplicity were performed.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.86 to 1.25
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Hide Description Time to first occurrence of >=30% pain reduction in average back pain from baseline to 6 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
Time Frame Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
Hide Outcome Measure Data
Hide Analysis Population Description
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed. The results are reported as the number of participants reporting at least a 30% reduction in the severity of back pain after time (t) in days.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 347 336
Measure Type: Number
Unit of Measure: participants
Day 0 0 0
Day 30 40 33
Day 60 91 86
Day 90 136 130
Day 120 175 162
Day 150 199 178
Day 180 212 200
Day 210 221 210
Day 240 221 211
Day 270 221 211
Day 300 221 211
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a >=30% reduction for average back pain at the 6-month endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.681
Comments Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.
Method Log Rank
Comments No adjustments for multiplicity were performed.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.86 to 1.26
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Hide Description Time to first occurrence of >= 30% pain reduction in average back pain from baseline to 12 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
Time Frame Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
Hide Outcome Measure Data
Hide Analysis Population Description
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 347 336
Measure Type: Number
Unit of Measure: participants
Day 0 0 0
Day 60 91 86
Day 120 175 162
Day 180 212 200
Day 240 221 211
Day 300 234 220
Day 360 238 226
Day 420 246 238
Day 480 246 238
Day 540 246 238
Day 600 246 238
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a >=30% reduction in average back pain at the 12-month endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.789
Comments Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.
Method Log Rank
Comments No adjustments for multiplicity were performed.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.86 to 1.23
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.
Hide Description Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 334 311
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.42  (0.45) -1.41  (0.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments Tested the null hypothesis that there is no statistically significant difference between the treatment groups in the proportion of participants with a reduction in disability at the 3-month endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.968
Comments No adjustments for multiplicity were performed.
Method ANCOVA
Comments The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.
10.Secondary Outcome
Title Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.
Hide Description Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Time Frame Baseline, 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 341 319
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.58  (0.48) -1.77  (0.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 6-month endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.568
Comments No adjustments for multiplicity were performed.
Method ANCOVA
Comments The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.
11.Secondary Outcome
Title Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.
Hide Description Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 343 322
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.09  (0.54) -2.12  (0.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 12-month endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.932
Comments No adjustments for multiplicity were performed.
Method ANCOVA
Comments The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.
12.Secondary Outcome
Title Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Hide Description QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Time Frame Baseline, 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 344 326
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.80  (1.11) -2.63  (1.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 6-month endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.814
Comments No adjustments for multiplicity were performed.
Method ANCOVA
Comments The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.
13.Secondary Outcome
Title Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Hide Description QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 344 327
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.74  (1.23) -5.27  (1.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 12-month endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.572
Comments No adjustments for multiplicity were performed.
Method ANCOVA
Comments The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.
14.Secondary Outcome
Title Number of Participants With Adverse Events (Safety) During 12 Months
Hide Description Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.
Time Frame Baseline through 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 360 350
Measure Type: Number
Unit of Measure: participants
Serious Adverse Events 39 50
Adverse Events 269 266
15.Secondary Outcome
Title Number of Participants With Adverse Events (Safety) During 18 Months
Hide Description Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.
Time Frame Baseline through 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 360 350
Measure Type: Number
Unit of Measure: participants
Serious Adverse Events 55 66
Adverse Events 277 273
16.Secondary Outcome
Title Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint
Hide Description 24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT). Participants are participants who were randomized and received at least one dose of the study drug.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 360 349
Measure Type: Number
Unit of Measure: participants
Responder 248 234
Non-Responder 112 115
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.600
Comments P-value is for responder versus non-responder.
Method Chi-squared
Comments [Not Specified]
17.Secondary Outcome
Title Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint
Hide Description 24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT). ITT participants were participants who randomized and received at least one dose of the study drug.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 360 349
Measure Type: Number
Unit of Measure: participants
Responder 260 242
Non-responder 100 107
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.399
Comments P-value is for responder versus non-responder.
Method Chi-squared
Comments [Not Specified]
18.Secondary Outcome
Title Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months
Hide Description Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 18 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
Time Frame Baseline through 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis includes number of randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 360 349
Measure Type: Number
Unit of Measure: participants
248 234
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.453
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.89 to 1.28
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months
Hide Description Time to first occurrence of >=30% pain reduction in average back pain from baseline to 18 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
Time Frame Baseline through 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 360 349
Measure Type: Number
Unit of Measure: participants
260 242
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.353
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.91 to 1.30
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.
Hide Description Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Pooled site, baseline glucocorticoid usage status (yes/no) and baseline score were controlled for.
Time Frame Baseline, 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 343 323
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.21  (0.54) -3.19  (0.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.943
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Hide Description QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Time Frame Baseline, 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description:
Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Overall Number of Participants Analyzed 344 327
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.67  (1.27) -5.17  (1.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.553
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Baseline to 18 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Teriparatide Risedronate
Hide Arm/Group Description Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
All-Cause Mortality
Teriparatide Risedronate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Teriparatide Risedronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/360 (15.28%)      66/350 (18.86%)    
Blood and lymphatic system disorders     
Anaemia  1  2/360 (0.56%)  2 3/350 (0.86%)  3
Cardiac disorders     
Atrial fibrillation  1  0/360 (0.00%)  0 3/350 (0.86%)  4
Atrioventricular block complete  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Bundle branch block left  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Cardiac failure  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Cardiac failure congestive  1  1/360 (0.28%)  1 1/350 (0.29%)  1
Coronary artery disease  1  0/360 (0.00%)  0 2/350 (0.57%)  2
Ventricular failure  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Ear and labyrinth disorders     
Vertigo  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Eye disorders     
Glaucoma  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Oscillopsia  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Abdominal pain upper  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Ascites  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Constipation  1  0/360 (0.00%)  0 3/350 (0.86%)  3
Crohn's disease  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Gastric ulcer  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Gastrointestinal haemorrhage  1  1/360 (0.28%)  2 0/350 (0.00%)  0
Mouth ulceration  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Nausea  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Pancreatitis  1  3/360 (0.83%)  3 0/350 (0.00%)  0
Peptic ulcer  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Pneumoperitoneum  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Tongue disorder  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Vomiting  1  0/360 (0.00%)  0 2/350 (0.57%)  2
General disorders     
Chest pain  1  1/360 (0.28%)  1 3/350 (0.86%)  3
Death  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Non-cardiac chest pain  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Oedema peripheral  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Sudden death  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Hepatobiliary disorders     
Bile duct stenosis  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Bile duct stone  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Biliary dilatation  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Cholecystitis  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Cholecystitis acute  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Cholelithiasis  1  3/360 (0.83%)  3 0/350 (0.00%)  0
Hepatic lesion  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Infections and infestations     
Abscess limb  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Blister infected  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Bronchiectasis  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Bronchitis  1  0/360 (0.00%)  0 2/350 (0.57%)  2
Cellulitis  1  1/360 (0.28%)  1 1/350 (0.29%)  1
Diverticulitis  1  0/360 (0.00%)  0 4/350 (1.14%)  4
Helicobacter gastritis  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Herpes zoster disseminated  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Infection  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Lower respiratory tract infection  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Osteomyelitis acute  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Pelvic abscess  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Pneumonia  1  2/360 (0.56%)  2 1/350 (0.29%)  2
Pyelonephritis  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Respiratory tract infection  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Sepsis  1  1/360 (0.28%)  1 1/350 (0.29%)  1
Septic shock  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Staphylococcal bacteraemia  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Staphylococcal infection  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Urinary tract infection  1  1/360 (0.28%)  1 1/350 (0.29%)  1
Urosepsis  1  1/360 (0.28%)  1 1/350 (0.29%)  1
Vaginal abscess  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Wound infection  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Injury, poisoning and procedural complications     
Acetabulum fracture  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Anaemia postoperative  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Ankle fracture  1  2/360 (0.56%)  2 0/350 (0.00%)  0
Clavicle fracture  1  0/360 (0.00%)  0 2/350 (0.57%)  3
Contusion  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Fall  1  5/360 (1.39%)  5 11/350 (3.14%)  11
Femoral neck fracture  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Femur fracture  1  1/360 (0.28%)  1 2/350 (0.57%)  2
Forearm fracture  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Fractured coccyx  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Gastrointestinal stoma complication  1  0/360 (0.00%)  0 1/350 (0.29%)  3
Hip fracture  1  4/360 (1.11%)  4 1/350 (0.29%)  1
Humerus fracture  1  3/360 (0.83%)  4 0/350 (0.00%)  0
Overdose  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Pelvic fracture  1  1/360 (0.28%)  2 3/350 (0.86%)  3
Post procedural haematoma  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Radius fracture  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Rib fracture  1  0/360 (0.00%)  0 3/350 (0.86%)  3
Road traffic accident  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Spinal fracture  1  0/360 (0.00%)  0 2/350 (0.57%)  3
Sternal fracture  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Thermal burn  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Thoracic vertebral fracture  1  0/360 (0.00%)  0 2/350 (0.57%)  2
Traumatic haematoma  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Ulna fracture  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Upper limb fracture  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Wrist fracture  1  2/360 (0.56%)  2 0/350 (0.00%)  0
Investigations     
Electrocardiogram QT prolonged  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Metabolism and nutrition disorders     
Cachexia  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Dehydration  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Diabetes mellitus inadequate control  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Failure to thrive  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/360 (0.00%)  0 2/350 (0.57%)  2
Back pain  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Fracture nonunion  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Muscle haemorrhage  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Osteoarthritis  1  2/360 (0.56%)  3 3/350 (0.86%)  3
Pain in extremity  1  0/360 (0.00%)  0 2/350 (0.57%)  2
Rhabdomyolysis  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Scleroderma  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Brain neoplasm  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Breast cancer  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Breast cancer metastatic  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Lung neoplasm  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Myelodysplastic syndrome  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Myelodysplastic syndrome transformation  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Rectal cancer  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Renal neoplasm  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Small cell lung cancer stage unspecified  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Uterine leiomyoma  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Nervous system disorders     
Cerebral haemorrhage  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Cerebrovascular accident  1  1/360 (0.28%)  1 6/350 (1.71%)  7
Dizziness  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Embolic stroke  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Encephalopathy  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Hyperreflexia  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Ischaemic stroke  1  2/360 (0.56%)  2 0/350 (0.00%)  0
Myoclonus  1  2/360 (0.56%)  2 0/350 (0.00%)  0
Nystagmus  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Sciatica  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Transient ischaemic attack  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Tremor  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Psychiatric disorders     
Agitation  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Depression  1  1/360 (0.28%)  1 1/350 (0.29%)  1
Sleep disorder  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Suicide attempt  1  2/360 (0.56%)  2 0/350 (0.00%)  0
Renal and urinary disorders     
Oliguria  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Reproductive system and breast disorders     
Ovarian mass  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Uterine prolapse  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Vaginal prolapse  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Atelectasis  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Chronic obstructive pulmonary disease  1  1/360 (0.28%)  1 3/350 (0.86%)  3
Dyspnoea  1  0/360 (0.00%)  0 2/350 (0.57%)  2
Pleural effusion  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Pleural haemorrhage  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Pulmonary thrombosis  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Respiratory failure  1  0/360 (0.00%)  0 2/350 (0.57%)  2
Social circumstances     
Activities of daily living impaired  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Surgical and medical procedures     
Knee arthroplasty  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Vertebroplasty  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Vascular disorders     
Deep vein thrombosis  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Haemorrhage  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Hypertension  1  2/360 (0.56%)  2 1/350 (0.29%)  1
Hypertensive crisis  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Hypertensive emergency  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Hypotension  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Raynaud's phenomenon  1  1/360 (0.28%)  1 0/350 (0.00%)  0
Temporal arteritis  1  0/360 (0.00%)  0 2/350 (0.57%)  2
Vasospasm  1  0/360 (0.00%)  0 1/350 (0.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Teriparatide Risedronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   277/360 (76.94%)      273/350 (78.00%)    
Gastrointestinal disorders     
Diarrhoea  1  16/360 (4.44%)  19 22/350 (6.29%)  28
Nausea  1  29/360 (8.06%)  37 30/350 (8.57%)  38
Vomiting  1  9/360 (2.50%)  10 19/350 (5.43%)  22
Infections and infestations     
Bronchitis  1  22/360 (6.11%)  29 25/350 (7.14%)  27
Influenza  1  29/360 (8.06%)  34 30/350 (8.57%)  37
Nasopharyngitis  1  30/360 (8.33%)  35 25/350 (7.14%)  32
Upper respiratory tract infection  1  18/360 (5.00%)  25 14/350 (4.00%)  17
Urinary tract infection  1  23/360 (6.39%)  29 18/350 (5.14%)  20
Injury, poisoning and procedural complications     
Fall  1  33/360 (9.17%)  33 26/350 (7.43%)  35
Musculoskeletal and connective tissue disorders     
Arthralgia  1  36/360 (10.00%)  51 42/350 (12.00%)  51
Back pain  1  18/360 (5.00%)  19 21/350 (6.00%)  22
Muscle spasms  1  32/360 (8.89%)  36 15/350 (4.29%)  19
Musculoskeletal pain  1  20/360 (5.56%)  21 15/350 (4.29%)  18
Pain in extremity  1  25/360 (6.94%)  34 27/350 (7.71%)  32
Nervous system disorders     
Dizziness  1  21/360 (5.83%)  23 19/350 (5.43%)  21
Headache  1  34/360 (9.44%)  44 24/350 (6.86%)  25
Vascular disorders     
Hypertension  1  22/360 (6.11%)  22 21/350 (6.00%)  21
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00343252     History of Changes
Other Study ID Numbers: 9041
B3D-MC-GHCY ( Other Identifier: Eli Lilly and Company )
First Submitted: June 20, 2006
First Posted: June 22, 2006
Results First Submitted: June 8, 2010
Results First Posted: July 12, 2010
Last Update Posted: May 26, 2011