Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: San Francisco VA Health Care System; University of California, San Francisco
• Treatments: Denosumab; Zoledronic Acid

Criteria

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