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Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01674621
Recruitment Status : Completed
First Posted : August 29, 2012
Results First Posted : December 19, 2016
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Nordic Bioscience A/S
Information provided by (Responsible Party):
Radius Health, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Post Menopausal Osteoporosis
Interventions Drug: Abaloparatide Transdermal (50 mcg)
Drug: Abaloparatide Transdermal (100 mcg)
Drug: Abaloparatide Transdermal (150 mcg)
Drug: Abaloparatide Injection (80 mcg)
Drug: Abaloparatide Placebo
Enrollment 250
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months Abaloparatide-Subcutaneous (SC) Injection - 80 mcg daily injections for up to 6 months Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Period Title: Overall Study
Started 50 51 48 51 50
Modified Intent-to-Treat Population [1] 47 46 43 49 46
Safety Population [2] 50 51 47 51 50
Completed 45 43 41 45 44
Not Completed 5 8 7 6 6
Reason Not Completed
Adverse Event             3             2             5             5             1
Inability to Complete Study Procedures             0             0             0             0             2
Severe Abaloparatide-SC Hypersensitivity             0             0             0             1             0
Withdrawal by Subject             2             5             2             0             1
Other than specified             0             1             0             0             2
[1]
Randomized participants with pretreatment and end-of-treatment evaluable radiologic assessments.
[2]
All participants who received 1 or more doses of study medication.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg) Total
Hide Arm/Group Description Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months Total of all reporting groups
Overall Number of Baseline Participants 47 46 43 49 46 231
Hide Baseline Analysis Population Description
Modified Intent-to-Treat (mITT) population included randomized participants with pretreatment and end-of-treatment evaluable radiologic assessments.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 46 participants 43 participants 49 participants 46 participants 231 participants
65.9  (4.83) 65.7  (5.26) 66.3  (6.46) 66.4  (5.48) 66.5  (7.27) 66.2  (5.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 46 participants 43 participants 49 participants 46 participants 231 participants
Female
47
 100.0%
46
 100.0%
43
 100.0%
49
 100.0%
46
 100.0%
231
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months
Hide Description Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.
Time Frame Baseline, 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 47 46 43 49 46
Mean (Standard Deviation)
Unit of Measure: Percent change
1.87  (2.87) 2.33  (2.96) 2.95  (3.13) 5.80  (4.21) 0.04  (2.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0066
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.930
Confidence Interval (2-Sided) 95%
-5.555 to -2.305
Estimation Comments Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.470
Confidence Interval (2-Sided) 95%
-5.104 to -1.837
Estimation Comments Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.856
Confidence Interval (2-Sided) 95%
-4.519 to -1.193
Estimation Comments Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).
2.Secondary Outcome
Title Percent Change From Baseline in BMD of Total Hip at 6 Months
Hide Description Percent change in BMD as specified by DXA scans of the total hip.
Time Frame Baseline, 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants with pre-treatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 47 46 43 49 46
Mean (Standard Deviation)
Unit of Measure: Percent change
0.97  (1.95) 1.32  (1.96) 1.49  (1.73) 2.74  (3.05) -0.02  (2.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0547
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0056
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.768
Confidence Interval (2-Sided) 95%
-2.864 to -0.672
Estimation Comments Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.420
Confidence Interval (2-Sided) 95%
-2.522 to -0.318
Estimation Comments Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.247
Confidence Interval (2-Sided) 95%
-2.368 to -0.126
Estimation Comments Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).
3.Secondary Outcome
Title Percent Change From Baseline in BMD of Forearm at 6 Months
Hide Description Percent change in BMD as specified by DXA scans of the forearm.
Time Frame Baseline, 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 47 46 43 49 46
Mean (Standard Deviation)
Unit of Measure: Percent change
-0.24  (2.74) -0.16  (3.71) 0.84  (2.96) 0.33  (3.41) 0.05  (3.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9493
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9806
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5191
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.564
Confidence Interval (2-Sided) 95%
-2.168 to 1.040
Estimation Comments Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.483
Confidence Interval (2-Sided) 95%
-2.115 to 1.150
Estimation Comments Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.517
Confidence Interval (2-Sided) 95%
-1.106 to 2.139
Estimation Comments Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
4.Secondary Outcome
Title Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
Hide Description [Not Specified]
Time Frame Baseline, 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 47 46 43 49 46
Mean (Standard Deviation)
Unit of Measure: Percent change
-4.84  (23.87) 5.22  (43.66) -5.52  (37.86) 17.30  (42.76) 10.23  (64.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2549
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9115
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2390
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.146
Confidence Interval (2-Sided) 95%
-40.501 to -3.790
Estimation Comments Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.086
Confidence Interval (2-Sided) 95%
-30.543 to 6.372
Estimation Comments Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.828
Confidence Interval (2-Sided) 95%
-41.614 to -4.041
Estimation Comments Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).
5.Secondary Outcome
Title Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
Hide Description [Not Specified]
Time Frame Baseline, 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 47 46 43 49 46
Mean (Standard Deviation)
Unit of Measure: Percent change
-17.26  (22.86) -8.42  (29.51) -16.63  (25.11) 10.28  (72.31) -6.76  (31.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1632
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9834
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2179
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment (EOT) to each transdermal dose group versus placebo.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -27.541
Confidence Interval (2-Sided) 95%
-48.557 to -6.525
Estimation Comments Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.702
Confidence Interval (2-Sided) 95%
-39.835 to 2.430
Estimation Comments Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -26.914
Confidence Interval (2-Sided) 95%
-48.424 to -5.405
Estimation Comments Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
6.Secondary Outcome
Title Percent Change From Baseline in Serum Osteocalcin at 6 Months
Hide Description [Not Specified]
Time Frame Baseline, 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 47 46 43 49 46
Mean (Standard Deviation)
Unit of Measure: Percent change
-4.37  (19.36) 6.67  (33.38) -3.83  (22.01) 69.54  (81.79) -4.21  (27.55)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1200
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9998
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -73.906
Confidence Interval (2-Sided) 95%
-96.926 to -50.886
Estimation Comments Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -62.872
Confidence Interval (2-Sided) 95%
-86.019 to -39.725
Estimation Comments Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -73.367
Confidence Interval (2-Sided) 95%
-96.927 to -49.807
Estimation Comments Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
7.Secondary Outcome
Title Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
Hide Description [Not Specified]
Time Frame Baseline, 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 47 46 43 49 46
Mean (Standard Deviation)
Unit of Measure: Percent change
-12.76  (26.81) 1.52  (57.29) -6.78  (38.91) 97.64  (172.52) -7.26  (35.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8569
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6091
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9999
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of PINP from baseline to EOT to each transdermal dose group versus placebo.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -110.398
Confidence Interval (2-Sided) 95%
-156.966 to -63.831
Estimation Comments Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -96.115
Confidence Interval (2-Sided) 95%
-142.940 to -49.290
Estimation Comments Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -104.418
Confidence Interval (2-Sided) 95%
-152.079 to -56.758
Estimation Comments Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
8.Secondary Outcome
Title Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
Hide Description [Not Specified]
Time Frame Baseline, 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 47 46 43 49 46
Mean (Standard Deviation)
Unit of Measure: Percent change
-2.61  (28.77) 1.65  (48.66) -8.22  (54.84) 41.11  (104.12) 9.42  (22.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3483
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6839
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Transdermal Placebo (0 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1067
Comments Threshold for significance at 0.05 level.
Method Dunnett's test
Comments P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (50 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -43.721
Confidence Interval (2-Sided) 95%
-75.748 to -11.694
Estimation Comments Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (100 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -39.461
Confidence Interval (2-Sided) 95%
-71.665 to -7.257
Estimation Comments Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Abaloparatide Transdermal (150 mcg), Abaloparatide Injection (80 mcg)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -49.334
Confidence Interval (2-Sided) 95%
-82.113 to -16.555
Estimation Comments Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).
9.Secondary Outcome
Title Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
Hide Description A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section.
Time Frame Baseline up to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 50 51 47 51 50
Measure Type: Count of Participants
Unit of Measure: Participants
General appearance at Screening
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
General appearance at 6 months
0
   0.0%
0
   0.0%
1
   2.1%
1
   2.0%
0
   0.0%
Skin at Screening
28
  56.0%
24
  47.1%
17
  36.2%
14
  27.5%
21
  42.0%
Skin at 6 months
29
  58.0%
26
  51.0%
16
  34.0%
14
  27.5%
17
  34.0%
Head at Screening
6
  12.0%
3
   5.9%
2
   4.3%
5
   9.8%
1
   2.0%
Head at 6 months
6
  12.0%
4
   7.8%
3
   6.4%
4
   7.8%
2
   4.0%
Lungs at Screening
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
1
   2.0%
Lungs at 6 months
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
Breasts at Screening
4
   8.0%
7
  13.7%
3
   6.4%
3
   5.9%
11
  22.0%
Breasts at 6 months
4
   8.0%
7
  13.7%
3
   6.4%
4
   7.8%
10
  20.0%
Abdomen at Screening
7
  14.0%
8
  15.7%
4
   8.5%
9
  17.6%
4
   8.0%
Abdomen at 6 months
6
  12.0%
7
  13.7%
3
   6.4%
9
  17.6%
3
   6.0%
Lymph nodes at Screening
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
0
   0.0%
Lymph nodes at 6 months
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
Columna at Screening
1
   2.0%
3
   5.9%
7
  14.9%
4
   7.8%
1
   2.0%
Columna at 6 months
1
   2.0%
2
   3.9%
7
  14.9%
3
   5.9%
1
   2.0%
Extremities at Screening
21
  42.0%
13
  25.5%
14
  29.8%
23
  45.1%
21
  42.0%
Extremities at 6 months
23
  46.0%
10
  19.6%
14
  29.8%
25
  49.0%
21
  42.0%
Neurologic at Screening
0
   0.0%
0
   0.0%
0
   0.0%
2
   3.9%
1
   2.0%
Neurologic at 6 months
0
   0.0%
0
   0.0%
0
   0.0%
3
   5.9%
1
   2.0%
10.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes
Hide Description Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Baseline up to 7 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 50 51 47 51 50
Measure Type: Count of Participants
Unit of Measure: Participants
Hypertension
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
Blood Pressure Increased
0
   0.0%
0
   0.0%
1
   2.1%
1
   2.0%
0
   0.0%
Heart Rate increased
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
0
   0.0%
Dyspnoea
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
Dizziness
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result
Hide Description The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Baseline up to 7 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 50 51 47 51 50
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   2.1%
2
   3.9%
0
   0.0%
12.Secondary Outcome
Title Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4
Hide Description Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9*10^9/liter [L]; Grade 4 <1.0*10^9/L), platelets (Grade 3: 25.0-49.9*10^9/L; Grade 4: <25.0*10^9/L), haemoglobin (Grade 3: 65.0-79.0 grams [g]/L or 4.0-4.9 mmol/L; Grade 4: <65.0 g/L or <4.0 millimole [mmol]/L), granulocytes/bands (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5*10^9/L), lymphocytes (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5 *10^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, > 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Baseline up to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 50 51 47 51 50
Measure Type: Count of Participants
Unit of Measure: Participants
6
  12.0%
5
   9.8%
4
   8.5%
1
   2.0%
5
  10.0%
13.Secondary Outcome
Title Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
Hide Description Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), >1.0 g%, or >10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0*normal; Grade 4: >6.0*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units [U]/L*normal, Grade 4: >20.0 U/L*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), total bilirubin (Grade 3: 1.5-3.0*normal; Grade 4: >3.0*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Baseline up to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 50 51 47 51 50
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
Hide Description Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%*normal, Grade 4: >2.00%*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds [sec], Grade 4: >3.00 secs*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Baseline up to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description:
Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Overall Number of Participants Analyzed 50 51 47 51 50
Measure Type: Count of Participants
Unit of Measure: Participants
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Time Frame Baseline up to 7 Months
Adverse Event Reporting Description Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.
 
Arm/Group Title Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Hide Arm/Group Description Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
All-Cause Mortality
Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   2/51 (3.92%)   2/47 (4.26%)   4/51 (7.84%)   1/50 (2.00%) 
Cardiac disorders           
Coronary artery disease † 1  0/50 (0.00%)  0/51 (0.00%)  0/47 (0.00%)  1/51 (1.96%)  0/50 (0.00%) 
Gastrointestinal disorders           
Abdominal Pain † 1  0/50 (0.00%)  0/51 (0.00%)  0/47 (0.00%)  1/51 (1.96%)  0/50 (0.00%) 
Colitis † 1  0/50 (0.00%)  0/51 (0.00%)  1/47 (2.13%)  0/51 (0.00%)  0/50 (0.00%) 
Injury, poisoning and procedural complications           
Radius fracture † 1  0/50 (0.00%)  1/51 (1.96%)  0/47 (0.00%)  0/51 (0.00%)  0/50 (0.00%) 
Musculoskeletal and connective tissue disorders           
Osteoarthritis † 1  0/50 (0.00%)  0/51 (0.00%)  1/47 (2.13%)  1/51 (1.96%)  0/50 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Breast Cancer † 1  0/50 (0.00%)  0/51 (0.00%)  0/47 (0.00%)  1/51 (1.96%)  0/50 (0.00%) 
Cervix carcinoma † 1  0/50 (0.00%)  1/51 (1.96%)  0/47 (0.00%)  0/51 (0.00%)  0/50 (0.00%) 
Malignant melanoma † 1  0/50 (0.00%)  0/51 (0.00%)  0/47 (0.00%)  0/51 (0.00%)  1/50 (2.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abaloparatide Transdermal (50 mcg) Abaloparatide Transdermal (100 mcg) Abaloparatide Transdermal (150 mcg) Abaloparatide Injection (80 mcg) Abaloparatide Transdermal Placebo (0 mcg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   40/50 (80.00%)   40/51 (78.43%)   37/47 (78.72%)   41/51 (80.39%)   39/50 (78.00%) 
Cardiac disorders           
Palpitations † 1  0/50 (0.00%)  2/51 (3.92%)  0/47 (0.00%)  3/51 (5.88%)  0/50 (0.00%) 
Gastrointestinal disorders           
Diarrhoea † 1  4/50 (8.00%)  0/51 (0.00%)  3/47 (6.38%)  1/51 (1.96%)  0/50 (0.00%) 
Nausea † 1  2/50 (4.00%)  3/51 (5.88%)  6/47 (12.77%)  3/51 (5.88%)  2/50 (4.00%) 
General disorders           
Application site erythema † 1  4/50 (8.00%)  5/51 (9.80%)  4/47 (8.51%)  0/51 (0.00%)  2/50 (4.00%) 
Application site pruritus † 1  0/50 (0.00%)  1/51 (1.96%)  4/47 (8.51%)  0/51 (0.00%)  0/50 (0.00%) 
Influenza like illness † 1  1/50 (2.00%)  3/51 (5.88%)  1/47 (2.13%)  1/51 (1.96%)  2/50 (4.00%) 
Injection site erythema † 1  0/50 (0.00%)  0/51 (0.00%)  0/47 (0.00%)  3/51 (5.88%)  0/50 (0.00%) 
Infections and infestations           
Bronchitis † 1  0/50 (0.00%)  0/51 (0.00%)  4/47 (8.51%)  1/51 (1.96%)  1/50 (2.00%) 
Cystitis † 1  2/50 (4.00%)  0/51 (0.00%)  4/47 (8.51%)  1/51 (1.96%)  1/50 (2.00%) 
Influenza † 1  4/50 (8.00%)  4/51 (7.84%)  2/47 (4.26%)  5/51 (9.80%)  4/50 (8.00%) 
Nasopharyngitis † 1  11/50 (22.00%)  10/51 (19.61%)  8/47 (17.02%)  13/51 (25.49%)  9/50 (18.00%) 
Upper respiratory tract infection † 1  0/50 (0.00%)  1/51 (1.96%)  0/47 (0.00%)  3/51 (5.88%)  1/50 (2.00%) 
Metabolism and nutrition disorders           
Hypocalcaemia † 1  3/50 (6.00%)  3/51 (5.88%)  1/47 (2.13%)  1/51 (1.96%)  2/50 (4.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia † 1  1/50 (2.00%)  0/51 (0.00%)  4/47 (8.51%)  3/51 (5.88%)  3/50 (6.00%) 
Back pain † 1  1/50 (2.00%)  4/51 (7.84%)  3/47 (6.38%)  3/51 (5.88%)  5/50 (10.00%) 
Nervous system disorders           
Dizziness † 1  2/50 (4.00%)  2/51 (3.92%)  3/47 (6.38%)  8/51 (15.69%)  1/50 (2.00%) 
Headache † 1  2/50 (4.00%)  2/51 (3.92%)  5/47 (10.64%)  5/51 (9.80%)  5/50 (10.00%) 
Renal and urinary disorders           
Hypercalciuria † 1  0/50 (0.00%)  1/51 (1.96%)  2/47 (4.26%)  3/51 (5.88%)  3/50 (6.00%) 
Respiratory, thoracic and mediastinal disorders           
Oropharyngeal pain † 1  3/50 (6.00%)  1/51 (1.96%)  3/47 (6.38%)  0/51 (0.00%)  1/50 (2.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
[Not Specified]
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 may not be published prior to the Study Report completion. Investigators may publish results, providing a manuscript to the Sponsor =/> 30 days prior to its submission to a publisher. Sponsor will provide manuscript to Investigators =/> 30 days prior to its submission. Investigator shall comply with Sponsor's policy, withholding publication for an additional 60 days to permit the Sponsor to obtain patent or other proprietary rights protection, if deemed necessary.
Results Point of Contact
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Name/Title: Program Director
Organization: Radius Health Inc.
Phone: (617) 551-4700
EMail: info@radiuspharm.com
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Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT01674621    
Other Study ID Numbers: BA058-05-007
2012-001921-29 ( EudraCT Number )
First Submitted: August 24, 2012
First Posted: August 29, 2012
Results First Submitted: October 25, 2016
Results First Posted: December 19, 2016
Last Update Posted: June 16, 2020