Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women (ACTIVE)
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ClinicalTrials.gov Identifier: NCT01343004 |
Recruitment Status :
Completed
First Posted : April 27, 2011
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
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Sponsor:
Radius Health, Inc.
Information provided by (Responsible Party):
Radius Health, Inc.
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Tracking Information | ||||
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First Submitted Date ICMJE | April 26, 2011 | |||
First Posted Date ICMJE | April 27, 2011 | |||
Results First Submitted Date ICMJE | October 25, 2016 | |||
Results First Posted Date ICMJE | March 1, 2017 | |||
Last Update Posted Date | March 1, 2017 | |||
Study Start Date ICMJE | April 2011 | |||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of Participants With New Vertebral Fractures at 18 Months [ Time Frame: 18 months ] | |||
Original Primary Outcome Measures ICMJE |
New vertebral fractures [ Time Frame: 18 months ] Number of BA058-treated patients showing new vertebral fractures by X-ray at End-of-Treatment when compared to Placebo in postmenopausal women
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women | |||
Official Title ICMJE | A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at Risk of Fracture | |||
Brief Summary | The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures. | |||
Detailed Description | This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter international study to evaluate the efficacy and safety of BA058 (abaloparatide) 80 µg in the prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe osteoporosis. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
2463 | |||
Original Estimated Enrollment ICMJE |
2400 | |||
Actual Study Completion Date ICMJE | October 2014 | |||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 85 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Brazil, Czech Republic, Denmark, Estonia, Hong Kong, Lithuania, Poland, Romania, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01343004 | |||
Other Study ID Numbers ICMJE | BA058-05-003 ACTIVE Trial ( Other Identifier: Radius Health, Inc. ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Radius Health, Inc. | |||
Original Responsible Party | Program Director, Radius Health, Inc. | |||
Current Study Sponsor ICMJE | Radius Health, Inc. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Radius Health, Inc. | |||
Verification Date | January 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |