Trial · NCT00542425
Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
NCT00542425, Phase 2, Completed, Radius Health, Inc.; results first posted 2010-07-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis. Trials, record NCT00542425. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00542425
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
- NCT number
- NCT00542425
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 222 participants, actual
- Lead sponsor
- Radius Health, Inc.
- Conditions
- Osteoporosis
- Interventions
- teriparatide, Placebo, BA058 20 µg, BA058 40 µg, BA058 80 µg
- First posted
- 2007-10-11
- Last updated
- 2017-10-30
- Results first posted
- 2010-07-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Marker of Bone Metabolism, PINP | 6 months | PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth. |
| Primary | Change in Bone Mineral Density, Total Spine. | 6 months | Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24. |
| Secondary | Change in Bone Mineral Density, Femoral Neck. | 6 months | Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24. |
| Secondary | Change in Bone Mineral Density, Total Hip. | 6 months | Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24. |
| Secondary | Change in Bone Mineral Density, Total Spine. | 12 months | Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Marker of Bone Metabolism, PINP | 6 months | The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 193 of the 221 ITT patients had data available for analysis at Week 24. | Percent change from baseline | MEAN |
| PRIMARY | Change in Bone Mineral Density, Total Spine. | 6 months | The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 187 of the 221 ITT patients had data available for analysis at Week 24. | Percent change from baseline | MEAN |
| SECONDARY | Change in Bone Mineral Density, Femoral Neck. | 6 months | The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24. | Percent change from baseline | MEAN |
| SECONDARY | Change in Bone Mineral Density, Total Hip. | 6 months | The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24. | Percent change from baseline | MEAN |
| SECONDARY | Change in Bone Mineral Density, Total Spine. | 12 months | The extension population included any patient who continued in the extended 24 weeks of treatment; N=55. 49 of the 55 extension patients had data available for analysis at Week 48. | Percent change from baseline | MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Marker of Bone Metabolism, PINP | Placebo | -13.1 | Standard Deviation 26.47 | Percent change from baseline | |
| Change in Marker of Bone Metabolism, PINP | BA058 20 µg | 20.0 | Standard Deviation 61.05 | Percent change from baseline | |
| Change in Marker of Bone Metabolism, PINP | BA058 40 µg | 90.8 | Standard Deviation 116.92 | Percent change from baseline | |
| Change in Marker of Bone Metabolism, PINP | BA058 80 µg | 97.2 | Standard Deviation 123.88 | Percent change from baseline | |
| Change in Marker of Bone Metabolism, PINP | Teriparatide | 154.3 | Standard Deviation 213.07 | Percent change from baseline | |
| Change in Bone Mineral Density, Total Spine. | Placebo | 1.22 | Standard Deviation 3.211 | Percent change from baseline | |
| Change in Bone Mineral Density, Total Spine. | BA058 20 µg | 3.30 | Standard Deviation 2.068 | Percent change from baseline | |
| Change in Bone Mineral Density, Total Spine. | BA058 40 µg | 5.21 | Standard Deviation 4.427 | Percent change from baseline | |
| Change in Bone Mineral Density, Total Spine. | BA058 80 µg | 6.11 | Standard Deviation 3.744 | Percent change from baseline | |
| Change in Bone Mineral Density, Total Spine. | Teriparatide | 5.47 | Standard Deviation 4.218 | Percent change from baseline |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial 24 Weeks | STARTED | Placebo | 46 | |
| Initial 24 Weeks | STARTED | BA058 20 µg | 43 | |
| Initial 24 Weeks | STARTED | BA058 40 µg | 43 | |
| Initial 24 Weeks | STARTED | BA058 80 µg | 45 | |
| Initial 24 Weeks | STARTED | Teriparatide | 45 | |
| Initial 24 Weeks | COMPLETED | Placebo | 42 | |
| Initial 24 Weeks | COMPLETED | BA058 20 µg | 33 | |
| Initial 24 Weeks | COMPLETED | BA058 40 µg | 36 | |
| Initial 24 Weeks | COMPLETED | BA058 80 µg | 34 | |
| Initial 24 Weeks | COMPLETED | Teriparatide | 39 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events130
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 | Placebo | 0 | 45 | |
| other | Palpitations | Cardiac disorders | BA058 20 µg | 0 | 43 | |
| other | Palpitations | Cardiac disorders | BA058 40 µg | 0 | 43 | |
| other | Palpitations | Cardiac disorders | BA058 80 µg | 3 | 45 | |
| other | Palpitations | Cardiac disorders | Teriparatide | 1 | 45 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 45 | |
| other | Abdominal pain | Gastrointestinal disorders | BA058 20 µg | 3 | 43 | |
| other | Abdominal pain | Gastrointestinal disorders | BA058 40 µg | 1 | 43 | |
| other | Abdominal pain | Gastrointestinal disorders | BA058 80 µg | 0 | 45 | |
| other | Abdominal pain | Gastrointestinal disorders | Teriparatide | 0 | 45 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | BA058 20 µg | ||
| Total, all-cause mortality | BA058 40 µg | ||
| Total, all-cause mortality | BA058 80 µg | ||
| Total, all-cause mortality | Teriparatide | ||
| Total, other adverse events | Placebo | 30 | 45 |
| Total, other adverse events | BA058 20 µg | 31 | 43 |
| Total, other adverse events | BA058 40 µg | 32 | 43 |
| Total, other adverse events | BA058 80 µg | 33 | 45 |
| Total, other adverse events | Teriparatide | 35 | 45 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25393645 | DERIVED |
Source PubMed
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/NCT00542425
GET https://conductscience.org/api/trials/v1/NCT00542425/results?page=2