CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 enrolled
Drug / intervention
Denosumab +2 moredrug
Likely dose
Zoledronic Acid 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04087096
NCT04087096Phase 4Completed
CompareCT.gov

Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

Massachusetts General Hospital·interventional·Posted Sep 12, 2019·Updated Oct 29, 2025

In Brief

A Phase 4 clinical trial evaluating Denosumab, Placebo, and 1 other intervention for Bariatric Surgery Candidate and Bone Loss. Completed, enrolled 36 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBariatric Surgery Candidate, Bone Loss
CountriesUnited States
CollaboratorsUniversity of California, San Francisco, San Francisco VA Health Care System

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedSep 12, 2019
Enrollment StartAug 24, 2020
Primary CompletionAug 6, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 6.8 years ago

Interventions

Denosumabdrug

Denosumab will be administered at postoperative months 1, 7, and 13

Placebodrug

Placebo will be administered at postoperative months 1, 7, and 13

Zoledronic Aciddrug

Zoledronic Acid 5mg will be administered intravenously at postoperative month 19