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Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

NCT04087096 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-10-29

Study results available
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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.

Conditions

  • Bariatric Surgery Candidate
  • Bone Loss

Interventions

DRUG

Denosumab

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

DRUG

Placebo

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

DRUG

Zoledronic Acid

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-24
Primary Completion
2024-08-06
Completion
2024-08-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04087096 on ClinicalTrials.gov