Trial record 1 of 1 for:
BA058-05-021
Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis
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ClinicalTrials.gov Identifier: NCT04064411 |
Recruitment Status :
Active, not recruiting
First Posted : August 21, 2019
Last Update Posted : December 4, 2020
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Sponsor:
Radius Health, Inc.
Information provided by (Responsible Party):
Radius Health, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | August 19, 2019 | ||||
First Posted Date ICMJE | August 21, 2019 | ||||
Last Update Posted Date | December 4, 2020 | ||||
Actual Study Start Date ICMJE | August 5, 2019 | ||||
Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Percent change from baseline in lumbar spine BMD at 12 months [ Time Frame: 12 months ] percent change from baseline in BMD of lumbar spine using dual-energy X-ray absorptiometry (DXA) results; abaloparatide-sMTS compared with abaloparatide-SC
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis | ||||
Official Title ICMJE | A Randomized, Non-inferiority, Phase 3, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Abaloparatide-sMTS for the Treatment of Postmenopausal Women With Osteoporosis (the wearABLe Study) | ||||
Brief Summary | A 12-month study to compare the efficacy and safety of abaloparatide-sMTS with abaloparatide-subcutaneous (SC) | ||||
Detailed Description | This study aims to evaluate the non-inferiority of abaloparatide-sMTS 300 μg compared to abaloparatide-SC 80 μg based on lumbar spine bone mineral density (BMD) at 12 months and to evaluate the safety and tolerability of abaloparatide-sMTS in the treatment of postmenopausal women with osteoporosis | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: parallel assignment Masking: Single (Outcomes Assessor)Masking Description: outcomes assessor Primary Purpose: Treatment
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Condition ICMJE | Postmenopausal Osteoporosis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* 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 | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
474 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | October 2021 | ||||
Estimated Primary Completion Date | September 2021 (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 | Denmark, Hungary, Poland, Puerto Rico, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04064411 | ||||
Other Study ID Numbers ICMJE | BA058-05-021 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Radius Health, Inc. | ||||
Study Sponsor ICMJE | Radius Health, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Radius Health, Inc. | ||||
Verification Date | April 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |