CLINICAL TRIALS PROFILE FOR ABALOPARATIDE
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All Clinical Trials for ABALOPARATIDE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01343004 ↗ | Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women | Completed | Radius Health, Inc. | Phase 3 | 2011-04-01 | 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. |
| NCT01657162 ↗ | Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis | Completed | Radius Health, Inc. | Phase 3 | 2012-11-20 | The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417). |
| NCT01674621 ↗ | Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis | Completed | Nordic Bioscience A/S | Phase 2 | 2012-09-25 | To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment. |
| NCT01674621 ↗ | Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis | Completed | Radius Health, Inc. | Phase 2 | 2012-09-25 | To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment. |
| NCT03512262 ↗ | Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM) | Completed | Radius Health, Inc. | Phase 3 | 2018-03-30 | A 12 month study to measure the efficacy and safety of abaloparatide in men with osteoporosis. |
| NCT03623633 ↗ | Comparative Antiresorptive Efficacy Discontinuation of Denosumab | Recruiting | Massachusetts General Hospital | Phase 4 | 2018-11-30 | Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene. Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued. This study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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