Status:
COMPLETED
Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
University of California, San Francisco
San Francisco VA Health Care System
Conditions:
Bariatric Surgery Candidate
Bone Loss
Eligibility:
All Genders
25+ years
Phase:
PHASE4
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 s...
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 monoclon...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Postmenopausal women who are planning RYGB or SG surgery
- Men aged ≥ 50 years who are planning RYGB or SG surgery
- Exclusion criteria:
- Prior bariatric surgery
- Weight = 400 lbs (due to limitations of bone imaging equipment)
- Renal disease
- Hypercalcemia or hypocalcemia
- Hypomagnesemia
- Serum 25-OH vitamin D (25OHD) \< 20 ng/mL
- Hyperparathyroidism
- Liver disease (AST or ALT \> 2 x upper normal limit)
- HCT \< 32%
- History of malignancy (except basal cell carcinoma) in the past 1 year
- Significant cardiopulmonary disease
- Major psychiatric disease
- History of celiac disease or inflammatory bowel disease
- Excessive alcohol or substance abuse
- Paget's disease, primary hyperparathyroidism, or any other known congenital or acquired bone disease other than osteoporosis
- Current hyperthyroidism or use of levothyroxine with TSH \< 0.1 uIU/mL
- Current use of loop diuretics
- Current use or use in the past 12 months of oral bisphosphonates or DMAB
- Current use or use within the past 3 months of SERMs or calcitonin
- Current use or use within the past 3 months of estrogen
- Use of testosterone therapy if dose has changed within the last 3 months, or if dose change or discontinuation is planned in the upcoming 18 months
- Any current or previous use of teriparatide, strontium, or any parenteral bisphosphonate
- Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
- Extensive dental work involving extraction or dental implant within the past 2 months or planned in the upcoming 18 months
- DXA BMD T-score of \< -3.0 at PA spine, total hip, or femoral neck
- Current use of anti-VEGF drug
Exclusion
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04087096
Start Date
August 24 2020
End Date
August 6 2024
Last Update
October 29 2025
Active Locations (2)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114