Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

STATUS

Recruiting
End date

Aug 27, 2023
participants needed

36
sponsor

Massachusetts General Hospital

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Updated on 27 April 2022

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gastrectomy

denosumab

gastric bypass

roux-en-y

zoledronic acid

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.

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.

Details

Condition	Bariatric Surgery Candidate, Bone Loss
Treatment	Placebo, Zoledronic Acid, Denosumab
Clinical Study Identifier	NCT04087096
Sponsor	Massachusetts General Hospital
Last Modified on	27 April 2022

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Eligibility		Yes	No	Not Sure
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

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Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery