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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
36
Denosumab will be administered at postoperative months 1, 7, and 13
Placebo will be administered at postoperative months 1, 7, and 13
Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
University of California, San Francisco
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Percentage Change in Total Hip Bone Mineral Density
Time frame: Pre-operative baseline to post-operative month 19
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