Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

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
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPlacebo subcutaneous injection every 6 months
PlaceboZoledronic AcidPlacebo subcutaneous injection every 6 months
DenosumabZoledronic AcidDenosumab 60mg subcutaneous injection every 6 months
DenosumabDenosumabDenosumab 60mg subcutaneous injection every 6 months
Primary Outcome Measures
NameTimeMethod
Percentage change in total hip bone mineral densityPre-operative baseline to post-operative month 19
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

University of California, San Francisco

🇺🇸

San Francisco, California, United States

© Copyright 2024. All Rights Reserved by MedPath