CLINICAL TRIALS PROFILE FOR ABALOPARATIDE

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.
NCT03708926 ↗	Effect of Abaloparatide on Lumbar Disc Degeneration	Withdrawn	Johns Hopkins University	Phase 2	2021-03-01	Low back pain is a major public health issue as the leading cause of disability globally. Degeneration of intervertebral disc (IVD) disorder is once source of low back pain. Current treatment options for low back pain secondary to degeneration of intervertebral disc include conservative care, steroid injections, prescription pain medications, physical therapy, or surgery, such as discectomy or laminectomy. Treatments focus on addressing manifested symptoms rather than functional causes, and symptomatic treatment of discogenic low back pain is less than ideal. The investigators have recently found that parathyroid hormone (PTH) effectively attenuates disc degeneration in aged mice. This clinical trial will test if 3-months of daily PTH-related protein (PTHrP), abaloparatide will improve pain, function, and disc health in people with low back pain secondary to lumbar disc degeneration.

Clinical Trial Conditions for abaloparatide

Condition Name

Condition Name for abaloparatide
Intervention	Trials
Osteoporosis	5
Osteoporosis, Postmenopausal	3
Osteoporosis, Age-Related	2
Postmenopausal Osteoporosis	2

Condition MeSH

Condition MeSH for abaloparatide
Intervention	Trials
Osteoporosis	8
Osteoporosis, Postmenopausal	6
Fractures, Bone	3
Osteoporotic Fractures	1

Clinical Trial Locations for abaloparatide

Trials by Country

Trials by Country for abaloparatide
Location	Trials
United States	40
Poland	7
Estonia	3
Denmark	3
Italy	3

Trials by US State

Trials by US State for abaloparatide
Location	Trials
Georgia	5
Colorado	5
Maryland	4
New York	4
Massachusetts	3

Clinical Trial Progress for abaloparatide

Clinical Trial Phase

Clinical Trial Phase for abaloparatide
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	4
Phase 2	5

Clinical Trial Status

Clinical Trial Status for abaloparatide
Clinical Trial Phase	Trials
Recruiting	6
Completed	5
Not yet recruiting	2

Clinical Trial Sponsors for abaloparatide

Sponsor Name

Sponsor Name for abaloparatide
Sponsor	Trials
Radius Health, Inc.	8
Hospital for Special Surgery, New York	2
University of Wisconsin, Madison	1

Sponsor Type

Sponsor Type for abaloparatide
Sponsor	Trials
Other	17
Industry	9