Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery

• Status: Completed
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates whether zoledronic acid can prevent the high bone turnover 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
• Treatments: Diphosphonates; Ergocalciferols; Vitamin D; Vitamins; Zoledronic Acid

Criteria

Inclusion Criteria:

• Men must be age ≥ 50

• Women must be age ≥ 25 and postmenopausal

• Planning to receive RYGB or SG surgery

Exclusion Criteria:

• Age < 25

• Prior bariatric surgery

• Weight ≥ 400 lbs

• Liver or renal disease

• Hypercalcemia, hypocalcemia, or hypomagnesemia

• Serum 25-hydroxyvitamin D < 20 ng/mL

• History of bone-modifying disorders

• Use of bone-active medications

• Known sensitivity to bisphosphonates

• Extensive dental work involving extraction or dental implant within the past 2 months or planned in the upcoming 6 months