Trial · NCT01674621
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
NCT01674621, Phase 2, Completed, Radius Health, Inc.; results first posted 2016-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis. Trials, record NCT01674621. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01674621
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
- NCT number
- NCT01674621
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 250 participants, actual
- Lead sponsor
- Radius Health, Inc.
- Conditions
- Post Menopausal Osteoporosis
- Interventions
- Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal (100 mcg), Abaloparatide Transdermal (150 mcg), Abaloparatide Injection (80 mcg), Abaloparatide Placebo
- First posted
- 2012-08-29
- Last updated
- 2020-06-16
- Other registries' IDs
- eudract:2012-001921-29
- Results first posted
- 2016-12-19
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | Baseline, 6 Months | Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine. |
| Secondary | Percent Change From Baseline in BMD of Total Hip at 6 Months | Baseline, 6 Months | Percent change in BMD as specified by DXA scans of the total hip. |
| Secondary | Percent Change From Baseline in BMD of Forearm at 6 Months | Baseline, 6 Months | Percent change in BMD as specified by DXA scans of the forearm. |
| Secondary | Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months | Baseline, 6 Months | |
| Secondary | Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months | Baseline, 6 Months | |
| Secondary | Percent Change From Baseline in Serum Osteocalcin at 6 Months | Baseline, 6 Months | |
| Secondary | Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months | Baseline, 6 Months | |
| Secondary | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months | Baseline, 6 Months | |
| Secondary | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Baseline up to 6 Months | 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. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Baseline up to 7 Months | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in BMD of Total Hip at 6 Months | Baseline, 6 Months | mITT population included all participants with pre-treatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in BMD of Forearm at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Osteocalcin at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months | Baseline, 6 Months | mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized. | Percent change | MEAN |
| SECONDARY | Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months) | Baseline up to 6 Months | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes | Baseline up to 7 Months | Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group185
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | Abaloparatide Transdermal (50 mcg) | 1.87 | Standard Deviation 2.87 | Percent change | |
| Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | Abaloparatide Transdermal (100 mcg) | 2.33 | Standard Deviation 2.96 | Percent change | |
| Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | Abaloparatide Transdermal (150 mcg) | 2.95 | Standard Deviation 3.13 | Percent change | |
| Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | Abaloparatide Injection (80 mcg) | 5.80 | Standard Deviation 4.21 | Percent change | |
| Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months | Abaloparatide Transdermal Placebo (0 mcg) | 0.04 | Standard Deviation 2.47 | Percent change | |
| Percent Change From Baseline in BMD of Total Hip at 6 Months | Abaloparatide Transdermal (50 mcg) | 0.97 | Standard Deviation 1.95 | Percent change | |
| Percent Change From Baseline in BMD of Total Hip at 6 Months | Abaloparatide Transdermal (100 mcg) | 1.32 | Standard Deviation 1.96 | Percent change | |
| Percent Change From Baseline in BMD of Total Hip at 6 Months | Abaloparatide Transdermal (150 mcg) | 1.49 | Standard Deviation 1.73 | Percent change | |
| Percent Change From Baseline in BMD of Total Hip at 6 Months | Abaloparatide Injection (80 mcg) | 2.74 | Standard Deviation 3.05 | Percent change | |
| Percent Change From Baseline in BMD of Total Hip at 6 Months | Abaloparatide Transdermal Placebo (0 mcg) | -0.02 | Standard Deviation 2.39 | Percent change |
1 to 10 of 185Source ClinicalTrials.gov
See all 185 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abaloparatide Transdermal (50 mcg) | 50 | |
| Overall Study | STARTED | Abaloparatide Transdermal (100 mcg) | 51 | |
| Overall Study | STARTED | Abaloparatide Transdermal (150 mcg) | 48 | |
| Overall Study | STARTED | Abaloparatide Injection (80 mcg) | 51 | |
| Overall Study | STARTED | Abaloparatide Transdermal Placebo (0 mcg) | 50 | |
| Overall Study | Modified Intent-to-Treat Population | Abaloparatide Transdermal (50 mcg) | 47 | |
| Overall Study | Modified Intent-to-Treat Population | Abaloparatide Transdermal (100 mcg) | 46 | |
| Overall Study | Modified Intent-to-Treat Population | Abaloparatide Transdermal (150 mcg) | 43 | |
| Overall Study | Modified Intent-to-Treat Population | Abaloparatide Injection (80 mcg) | 49 | |
| Overall Study | Modified Intent-to-Treat Population | Abaloparatide Transdermal Placebo (0 mcg) | 46 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events135
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Abaloparatide Transdermal (50 mcg) | 0 | 50 | |
| other | Palpitations | Cardiac disorders | Abaloparatide Transdermal (100 mcg) | 2 | 51 | |
| other | Palpitations | Cardiac disorders | Abaloparatide Transdermal (150 mcg) | 0 | 47 | |
| other | Palpitations | Cardiac disorders | Abaloparatide Injection (80 mcg) | 3 | 51 | |
| other | Palpitations | Cardiac disorders | Abaloparatide Transdermal Placebo (0 mcg) | 0 | 50 | |
| other | Diarrhoea | Gastrointestinal disorders | Abaloparatide Transdermal (50 mcg) | 4 | 50 | |
| other | Diarrhoea | Gastrointestinal disorders | Abaloparatide Transdermal (100 mcg) | 0 | 51 | |
| other | Diarrhoea | Gastrointestinal disorders | Abaloparatide Transdermal (150 mcg) | 3 | 47 | |
| other | Diarrhoea | Gastrointestinal disorders | Abaloparatide Injection (80 mcg) | 1 | 51 | |
| other | Diarrhoea | Gastrointestinal disorders | Abaloparatide Transdermal Placebo (0 mcg) | 0 | 50 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abaloparatide Transdermal (50 mcg) | ||
| Total, all-cause mortality | Abaloparatide Transdermal (100 mcg) | ||
| Total, all-cause mortality | Abaloparatide Transdermal (150 mcg) | ||
| Total, all-cause mortality | Abaloparatide Injection (80 mcg) | ||
| Total, all-cause mortality | Abaloparatide Transdermal Placebo (0 mcg) | ||
| Total, other adverse events | Abaloparatide Transdermal (50 mcg) | 40 | 50 |
| Total, other adverse events | Abaloparatide Transdermal (100 mcg) | 40 | 51 |
| Total, other adverse events | Abaloparatide Transdermal (150 mcg) | 37 | 47 |
| Total, other adverse events | Abaloparatide Injection (80 mcg) | 41 | 51 |
| Total, other adverse events | Abaloparatide Transdermal Placebo (0 mcg) | 39 | 50 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01674621
GET https://conductscience.org/api/trials/v1/NCT01674621/results?page=2