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Healthy Body, Healthy Bones After Bariatric Surgery Trial

NCT04279392 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-09-24

Study results available
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Summary

One in three adults in the United States suffers from obesity. Bariatric surgery is an increasingly utilized and effective treatment for obesity and obesity-related comorbidities, however, the massive weight loss associated with bariatric surgery adversely affects bone leads to an increased risk of fracture. Bisphosphonate medications, such as zoledronic acid, are used to treat bone loss in patients with osteoporosis, and this study investigates whether this medication can prevent bone loss associated with surgical weight loss procedures.

Conditions

  • Bariatric Surgery Candidate
  • Bone Loss
  • Bone Resorption

Interventions

DRUG

Zoledronic Acid 5 mg/Bag 100 ml Inj

Zoledronic acid infusion

DRUG

Placebos

Saline infusion

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Laura D Bilek, PT, PhD · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-12-30
Completion
2022-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04279392 on ClinicalTrials.gov