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Effect of Teriparatide on Hip Fracture Healing

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ClinicalTrials.gov Identifier: NCT01473589
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : November 17, 2014
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Femur Neck Fracture
Interventions Drug: Teriparatide
Drug: Placebo
Dietary Supplement: Calcium supplementation
Dietary Supplement: Vitamin D supplementation
Enrollment 122
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description Teriparatide 20 micrograms (µg) administered once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements. Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Period Title: Overall Study
Started 60 62
Received at Least 1 Dose of Study Drug 60 [1] 61 [1]
Completed 6 Months 51 54
Completed 12 Months 49 48
Completed 49 46
Not Completed 11 16
Reason Not Completed
Adverse Event             1             1
Death             2             0
Lost to Follow-up             2             2
Protocol Violation             1             0
Withdrawal by Subject             5             11
Physician Decision             0             1
Entry criteria not met             0             1
[1]
Randomized participants who received at least 1 dose of study drug.
Arm/Group Title Teriparatide Placebo Total
Hide Arm/Group Description Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. Total of all reporting groups
Overall Number of Baseline Participants 60 61 121
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 61 participants 121 participants
68.49  (11.321) 70.96  (12.023) 69.73  (11.698)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 61 participants 121 participants
Female
43
  71.7%
44
  72.1%
87
  71.9%
Male
17
  28.3%
17
  27.9%
34
  28.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 61 participants 121 participants
Hispanic or Latino
0
   0.0%
1
   1.6%
1
   0.8%
Not Hispanic or Latino
26
  43.3%
27
  44.3%
53
  43.8%
Unknown or Not Reported
34
  56.7%
33
  54.1%
67
  55.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 61 participants 121 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
35
  58.3%
34
  55.7%
69
  57.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
25
  41.7%
27
  44.3%
52
  43.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 61 participants 121 participants
United States 1 1 2
Spain 7 8 15
Taiwan 10 9 19
Lithuania 2 2 4
Israel 3 4 7
India 2 1 3
Canada 3 1 4
Denmark 1 1 2
Australia 1 0 1
Latvia 2 3 5
Japan 14 15 29
New Zealand 5 6 11
Korea, Republic of 9 9 18
Sweden 0 1 1
Surgical screw type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 61 participants 121 participants
Cancellous Screws 54 53 107
Sliding Hip Screws 6 8 14
[1]
Measure Description: Surgical screws used in initial surgery to repair femur neck hip fracture.
1.Primary Outcome
Title Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture
Hide Description Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 60 61
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
87
(77 to 93)
86
(76 to 92)
2.Secondary Outcome
Title Percentage of Participants With Radiographic Evidence of Healing
Hide Description

The signs of femoral neck fracture healing included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing.

Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100.

Time Frame Randomization up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 60 61
Measure Type: Number
Unit of Measure: percentage of participants
78.3 78.7
3.Secondary Outcome
Title Percentage of Participants With Pain Control During Ambulation
Hide Description The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain with ambulation and no worsening of NRS scores >2 from baseline. Percentage was calculated as: (Number of participants with pain control during ambulation / total number of participants) * 100.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, received treatment, and had baseline and at least one nonmissing post-baseline measurement. Last observation carried forward (LOCF) values used.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 47 49
Measure Type: Number
Unit of Measure: percentage of participants
91.5 89.8
4.Secondary Outcome
Title Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
Hide Description The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants) * 100.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement for severe fracture-site pain in the last 24 hours. LOCF values used.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 50 51
Measure Type: Number
Unit of Measure: percentage of participants
88.0 82.4
5.Secondary Outcome
Title Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
Hide Description The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement. LOCF values used.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 47 50
Measure Type: Number
Unit of Measure: percentage of participants
89.4 88.0
6.Secondary Outcome
Title Percentage of Participants With Functional Evidence of Healing
Hide Description

Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s.

Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100.

Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, received at least 1 dose of study drug, and had either at least one nonmissing gait speed or non-ambulatory status. LOCF values used.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 48 50
Measure Type: Number
Unit of Measure: percentage of participants
85.4 74.0
7.Secondary Outcome
Title Percentage of Participants Able to Ambulate
Hide Description Ability to ambulate was defined as ambulatory with convalescent aid or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / number of total participants analyzed) * 100.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received at least 1 dose of study drug and had at least 1 nonmissing post-baseline measurement. LOCF values used.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 48 50
Measure Type: Number
Unit of Measure: percentage of participants
97.9 98
8.Secondary Outcome
Title Percentage of Participants Who Regain Their Prefracture Ambulatory Status
Hide Description Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number analyzed) * 100.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, received at least 1 dose of study drug, and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 56 58
Measure Type: Number
Unit of Measure: percentage of participants
73.2 56.9
9.Secondary Outcome
Title Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
Hide Description The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least Squares (LS) means was calculated using analysis of covariance (ANCOVA) and adjusted for baseline, treatment group, region, fracture type, and fixation type.
Time Frame Baseline, 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 47 50
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
During ambulation (n = 45, 46) 0.2  (0.37) 0.2  (0.36)
During 24 hours preceding visit (n = 47, 50) -0.3  (0.45) -0.8  (0.42)
On weight bearing (n = 46, 49) 0.7  (0.39) 0.8  (0.36)
10.Secondary Outcome
Title Mean Change From Baseline to 6 Months in Gait Speed
Hide Description The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, and fixation type.
Time Frame Baseline, up to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 45 47
Least Squares Mean (Standard Error)
Unit of Measure: m/s
-0.672  (2.128) 1.524  (2.018)
11.Secondary Outcome
Title Time to Revision Surgery
Hide Description Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.
Time Frame Baseline to revision surgery (up to 14.14 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, received at least 1 dose of study drug, and who did not have revision surgery or if they had revision surgery, it was adjudicated as not being related to the initial hip fracture surgery. Participants censored: Teriparatide = 51; placebo = 51.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 60 59
Median (Full Range)
Unit of Measure: days
358.5
(15 to 430)
350
(12 to 412)
12.Secondary Outcome
Title Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores
Hide Description SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
Time Frame Baseline, up to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 58 59
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
PCS Month 6 (n = 49, 49) -3.73  (1.2) -4.75  (1.2)
MCS Month 6 (n = 49, 49) -0.58  (2.1) -0.49  (2.1)
13.Secondary Outcome
Title Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
Hide Description WOMAC is: a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
Time Frame Baseline, up to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 58 59
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Physical Function Score - Month 6 (n=48, 51) 12.9  (4.36) 12.8  (4.25)
Pain Score - Month 6 ( n = 51, 51) 8.2  (3.76) 10.3  (3.68)
Stiffness Score - Month 6 (n = 51, 51) 13.1  (3.78) 11.8  (3.75)
14.Secondary Outcome
Title Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score
Hide Description The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worse imaginable health state) to 100 (best imaginable health state). LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, and region.
Time Frame Baseline, up to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur, and had baseline and at least 1 nonmissing post-baseline measurement.
Arm/Group Title Teriparatide Placebo
Hide Arm/Group Description:
Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
Overall Number of Participants Analyzed 51 51
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
7.4  (4.02) 7.6  (3.87)
Time Frame Randomization to Study Completion
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Teriparatide Placebo Follow-up Teriparatide Follow-up
Hide Arm/Group Description Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements. Follow-up after teriparatide 20 µg once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
All-Cause Mortality
Placebo Teriparatide Placebo Follow-up Teriparatide Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Teriparatide Placebo Follow-up Teriparatide Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/61 (9.84%)      2/60 (3.33%)      6/53 (11.32%)      2/49 (4.08%)    
Cardiac disorders         
Bradyarrhythmia  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Supraventricular tachycardia  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Gastrointestinal disorders         
Gastritis  1  1/61 (1.64%)  1 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Hepatobiliary disorders         
Hepatitis toxic  1  1/61 (1.64%)  1 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Infections and infestations         
Liver abscess  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Pneumonia  1  0/61 (0.00%)  0 1/60 (1.67%)  1 1/53 (1.89%)  1 0/49 (0.00%)  0
Urinary tract infection  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Injury, poisoning and procedural complications         
Fall  1  1/61 (1.64%)  1 1/60 (1.67%)  1 1/53 (1.89%)  1 0/49 (0.00%)  0
Femoral neck fracture  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Femur fracture  1  1/61 (1.64%)  1 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Subdural haematoma  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Wound  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Bursitis  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Fracture nonunion  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Osteonecrosis  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Transitional cell carcinoma  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Nervous system disorders         
Syncope  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Transient ischaemic attack  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Psychiatric disorders         
Confusional state  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Renal and urinary disorders         
Haematuria  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Teriparatide Placebo Follow-up Teriparatide Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/61 (55.74%)      31/60 (51.67%)      18/53 (33.96%)      16/49 (32.65%)    
Cardiac disorders         
Arrhythmia  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Palpitations  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Ear and labyrinth disorders         
Vertigo  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Eye disorders         
Cataract  1  1/61 (1.64%)  1 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Conjunctival haemorrhage  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Conjunctivitis  1  1/61 (1.64%)  1 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Dacryostenosis acquired  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Glaucoma  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Macular degeneration  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain lower  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Constipation  1  1/61 (1.64%)  1 3/60 (5.00%)  3 0/53 (0.00%)  0 1/49 (2.04%)  1
Dental caries  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Diarrhoea  1  1/61 (1.64%)  1 1/60 (1.67%)  1 1/53 (1.89%)  1 0/49 (0.00%)  0
Diverticulum intestinal  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Faecal incontinence  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Faecaloma  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 1/49 (2.04%)  1
Gastritis  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Gastritis atrophic  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Gastritis erosive  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Gastrointestinal disorder  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Gastrooesophageal reflux disease  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Gingival swelling  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Haemorrhoids  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Hiatus hernia  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 1/49 (2.04%)  1
Nausea  1  0/61 (0.00%)  0 2/60 (3.33%)  2 0/53 (0.00%)  0 1/49 (2.04%)  1
Periodontal inflammation  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Stomatitis  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Toothache  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Vomiting  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
General disorders         
Asthenia  1  2/61 (3.28%)  2 2/60 (3.33%)  2 0/53 (0.00%)  0 0/49 (0.00%)  0
Facial pain  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Gait disturbance  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Oedema peripheral  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Pain  1  1/61 (1.64%)  1 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Pyrexia  1  0/61 (0.00%)  0 1/60 (1.67%)  1 1/53 (1.89%)  1 0/49 (0.00%)  0
Sense of oppression  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Thirst  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Hepatobiliary disorders         
Cholelithiasis  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Infections and infestations         
Adenoiditis  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Bronchitis  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 2/49 (4.08%)  2
Cellulitis  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Cervicitis  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Diverticulitis  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Ear infection  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Eye infection  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Gastroenteritis  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Helicobacter infection  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Nail infection  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Nasopharyngitis  1  3/61 (4.92%)  4 4/60 (6.67%)  5 0/53 (0.00%)  0 0/49 (0.00%)  0
Oral candidiasis  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Oral herpes  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Parotitis  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Rhinitis  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Skin infection  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Tinea pedis  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Upper respiratory tract infection  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Urinary tract infection  1  2/61 (3.28%)  2 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Wound infection  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Wound infection staphylococcal  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Injury, poisoning and procedural complications         
Bone contusion  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Chest injury  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Contusion  1  0/61 (0.00%)  0 1/60 (1.67%)  4 1/53 (1.89%)  1 0/49 (0.00%)  0
Excoriation  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Fall  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Femur fracture  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Humerus fracture  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Joint injury  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Laceration  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Spinal compression fracture  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Tooth fracture  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Investigations         
Blood alkaline phosphatase increased  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Blood pressure increased  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Weight decreased  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Folate deficiency  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Hypercalcaemia  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Hyperlipidaemia  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Hypoglycaemia  1  0/61 (0.00%)  0 1/60 (1.67%)  1 1/53 (1.89%)  1 0/49 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  3/61 (4.92%)  3 3/60 (5.00%)  3 0/53 (0.00%)  0 3/49 (6.12%)  3
Back pain  1  6/61 (9.84%)  6 3/60 (5.00%)  3 2/53 (3.77%)  2 0/49 (0.00%)  0
Chondropathy  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Coccydynia  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Flank pain  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Muscular weakness  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Musculoskeletal pain  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Myalgia  1  1/61 (1.64%)  1 2/60 (3.33%)  2 0/53 (0.00%)  0 0/49 (0.00%)  0
Neck pain  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Osteoarthritis  1  4/61 (6.56%)  4 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Osteonecrosis  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 2/49 (4.08%)  2
Osteoporosis  1  1/61 (1.64%)  1 3/60 (5.00%)  3 0/53 (0.00%)  0 0/49 (0.00%)  0
Pain in extremity  1  0/61 (0.00%)  0 1/60 (1.67%)  1 1/53 (1.89%)  1 0/49 (0.00%)  0
Spinal column stenosis  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Spinal osteoarthritis  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Tenosynovitis stenosans  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Trigger finger  1  1/61 (1.64%)  1 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Seborrhoeic keratosis  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Nervous system disorders         
Carotid arteriosclerosis  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Carpal tunnel syndrome  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Dizziness  1  3/61 (4.92%)  3 1/60 (1.67%)  1 1/53 (1.89%)  1 1/49 (2.04%)  1
Headache  1  1/61 (1.64%)  1 1/60 (1.67%)  1 1/53 (1.89%)  1 0/49 (0.00%)  0
Hypoaesthesia  1  0/61 (0.00%)  0 2/60 (3.33%)  2 0/53 (0.00%)  0 0/49 (0.00%)  0
Neuralgia  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 1/49 (2.04%)  1
Paraesthesia  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Parkinson's disease  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Presyncope  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Syncope  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Tremor  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Vascular dementia  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Vertebral artery stenosis  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Psychiatric disorders         
Anxiety  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Behavioural and psychiatric symptoms of dementia  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Depression  1  1/61 (1.64%)  1 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Disorientation  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Insomnia  1  2/61 (3.28%)  2 3/60 (5.00%)  3 0/53 (0.00%)  0 0/49 (0.00%)  0
Mental status changes  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Renal and urinary disorders         
Pollakiuria  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Urinary retention  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Reproductive system and breast disorders         
Atrophic vulvovaginitis  1  0/44 (0.00%)  0 0/43 (0.00%)  0 1/39 (2.56%)  1 0/39 (0.00%)  0
Prostatitis  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/14 (0.00%)  0 0/10 (0.00%)  0
Vaginal haemorrhage  1  1/44 (2.27%)  1 0/43 (0.00%)  0 0/39 (0.00%)  0 0/39 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Bronchiectasis  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  2 0/49 (0.00%)  0
Bronchitis chronic  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Cough  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Oropharyngeal pain  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Respiratory failure  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Upper respiratory tract inflammation  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Skin and subcutaneous tissue disorders         
Actinic keratosis  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Alopecia  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Asteatosis  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Dermatitis contact  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Dyshidrotic eczema  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Hypertrophic scar  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Ingrowing nail  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Pruritus  1  0/61 (0.00%)  0 0/60 (0.00%)  0 1/53 (1.89%)  1 0/49 (0.00%)  0
Rash  1  1/61 (1.64%)  1 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Skin ulcer  1  0/61 (0.00%)  0 0/60 (0.00%)  0 0/53 (0.00%)  0 1/49 (2.04%)  1
Surgical and medical procedures         
Cataract operation  1  1/61 (1.64%)  2 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Cholecystectomy  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Sebaceous cyst excision  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Vascular disorders         
Hypertension  1  1/61 (1.64%)  1 0/60 (0.00%)  0 0/53 (0.00%)  0 0/49 (0.00%)  0
Thrombosis  1  0/61 (0.00%)  0 1/60 (1.67%)  1 0/53 (0.00%)  0 0/49 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01473589    
Other Study ID Numbers: 13467
B3D-MC-GHDN ( Other Identifier: Eli Lilly and Company )
First Submitted: November 14, 2011
First Posted: November 17, 2011
Results First Submitted: November 10, 2014
Results First Posted: November 17, 2014
Last Update Posted: April 16, 2015