Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Bariatric Surgery Candidate

Bone Loss

Treatments

Drug: Denosumab

Drug: Zoledronic Acid

Drug: Placebo

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT04087096

20187525

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

25+ years old

Volunteers

No Healthy Volunteers

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