NCT04087096

Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bariatric Surgery Candidate
• Bone Loss

Interventions

Type	Name	Description
DRUG	Denosumab	Denosumab will be administered at postoperative months 1, 7, and 13
DRUG	Placebo	Placebo will be administered at postoperative months 1, 7, and 13
DRUG	Zoledronic Acid	Zoledronic Acid 5mg will be administered intravenously at postoperative month 19

Timeline

• Start date: 2020-08-24
• Primary completion: 2024-08-06
• Completion: 2024-08-06
• First posted: 2019-09-12
• Last updated: 2025-10-29
• Results posted: 2025-10-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study