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Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)

NCT02589600 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2023-09-26

Study results available
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Summary

The goal of this study is to perform the first fracture reduction clinical trial with a potent antiresorptive agent (intravenous zoledronic acid) in the most vulnerable long-term care population.

Conditions

  • Osteoporotic Fractures
  • Osteoporosis, Postmenopausal

Interventions

DRUG

Zoledronic acid

Annual intravenous 5.0 mg

DIETARY_SUPPLEMENT

vitamin D

800 IU daily

DIETARY_SUPPLEMENT

calcium

approximately 1200 mg (dietary and supplement)

OTHER

Saline

Annual intravenous saline placebo

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Aging (NIA)

    collaborator NIH

  • Susan L. Greenspan

    lead OTHER

Principal Investigators

  • Susan L Greenspan, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2022-06-22
Completion
2022-06-22

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 NCT02589600 on ClinicalTrials.gov