Clinical Research Directory
Browse clinical research sites, groups, and studies.
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Sponsor: Hospital for Special Surgery, New York
Summary
This randomized open label clinical trial will evaluate the effect of continued denosumab alone over 18 months versus denosumab with added abaloparatide for 18 months. 70 postmenopausal women will be enrolled over a period of 18 months. The co-primary outcomes will be group differences in bone mineral density (BMD) of the total hip and lumbar spine at 18 months. Secondary outcomes will include group differences in bone mineral density (BMD) at the femoral neck, trochanter and wrist sites at 6, 12 and 18 months, spine and total hip bone mineral density (BMD) at 6 and 12 months and trabecular bone score (TBS) at 18 months. Secondary outcomes will also include within group changes from baseline for each of these variables. Bone turnover markers will also be measured to demonstrate that PINP levels will increase with administration of abaloparatide even in the setting of ongoing denosumab, while CTX levels will remain low.
Key Details
Gender
FEMALE
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2021-02-01
Completion Date
2026-12-01
Last Updated
2025-05-02
Healthy Volunteers
Yes
Conditions
Interventions
Denosumab Injection
Denosumab alone: 3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment.
Abaloparatide
Combination therapy: 3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment, with added abaloparatide 80 mcg subcutaneously daily, started within 6 months of the last denosumab treatment, for a total of 18 months.
Locations (1)
Hospital for Special Surgery
New York, New York, United States