Status:
ACTIVE_NOT_RECRUITING
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborating Sponsors:
Radius Health, Inc.
Crozer-Keystone Health System
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
45+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Some women on denosumab treatment for osteoporosis remain at high risk for fracture. These include women who sustain incident fractures on denosumab and those who have declining bone mineral density (...
Eligibility Criteria
Inclusion
- postmenopausal woman \>age 45 of any racial origin
- Participants will have received at least 4 prior denosumab treatments and be within 7 months from their last denosumab injection
- Participants are willing to participate for the duration of the study and have no physical or psychological illness that would prohibit them from participating.
- Diagnosis of osteoporosis based on bone mineral density and/or fracture criteria. Osteoporosis will be defined by bone mineral density T-Score \< -2.5 at lumbar spine (at least 2 evaluable vertebrae between L1 and L4), total hip or femoral neck. Osteoporosis will also be defined clinically in women with osteoporotic fractures within the preceding 5 years, including clinical vertebral or nonvertebral fractures or vertebral fracture confirmed by radiograph or lateral DXA VFA image, along with a DXA BMD T-Score \< -1.5 at one or more skeletal sites.
Exclusion
- Use of drugs other than denosumab (within the preceding 3 months) known to affect skeletal or calcium homeostasis.
- Fewer than 2 evaluable lumbar vertebrae
- A history of a symptomatic renal stone within the past 2 years or history of multiple symptomatic renal stones within the preceding 10 years
- Skeletal Disorders other than osteoporosis, including hypercalcemia, hyperparathyroidism, or Paget's Disease
- History of external or internal radiation therapy
- Estimated GFR below 30 ml/min
- Any contraindications to receipt of Abaloparatide or Denosumab
- History of any cancer in past 5 years (except basal/squamous skin cancer)
- Unexplained elevation of Serum Alkaline Phosphatase
- History of atypical femoral fracture
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04467983
Start Date
February 1 2021
End Date
December 1 2026
Last Update
May 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital for Special Surgery
New York, New York, United States, 10021