NCT03424239

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators are evaluating the ability of a single dose of zoledronic acid to improve bone outcomes after RYGB or SG surgery. The investigators have previously shown that RYGB and SG have negative effects on bone density, bone microarchitecture, and that bariatric procedures potentially increase the risk of fractures. The purpose of this study is to evaluate the safety and efficacy of zoledronic acid to prevent the high-turnover bone loss that occurs in adults who have chosen to undergo RYGB or SG.

Conditions

• Bariatric Surgery Candidate

Interventions

Type	Name	Description
DRUG	Zoledronic Acid	5mg zoledronic acid
DIETARY_SUPPLEMENT	Calcium citrate + vitamin D	Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3
DIETARY_SUPPLEMENT	Vitamin D3	1000IU Vitamin D3 gummy

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2018-02-06
• Last updated: 2021-04-29
• Results posted: 2021-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study