Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
- Conditions
- Interventions
- Registration Number
- NCT04087096
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
Bariatric surgery leads to bone loss and increases fracture risk. This study evaluates whether denosumab can prevent the high-turnover bone loss that occurs after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.
- Detailed Description
Bariatric surgery is a highly effective weight loss treatment, but one of the unintended side effects of these procedures is high-turnover bone loss and metabolic bone disease. Denosumab is a monoclonal antibody to RANKL that acts as a potent inhibitor of bone resorption. The investigators are conducting a randomized placebo-controlled trial to evaluate the ...
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo subcutaneous injection every 6 months Placebo Zoledronic Acid Placebo subcutaneous injection every 6 months Denosumab Zoledronic Acid Denosumab 60mg subcutaneous injection every 6 months Denosumab Denosumab Denosumab 60mg subcutaneous injection every 6 months
- Primary Outcome Measures
Name Time Method Percentage change in total hip bone mineral density Pre-operative baseline to post-operative month 19
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States