Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
- Conditions
- Bariatric Surgery CandidateBone Loss
- 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 ability of denosumab to prevent bone loss after RYGB or SG surgery in older adults. At the conclusion of the study, all participants will be given zoledronic acid.
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