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Zoledronic Acid for Osteoporosis in the Elderly

NCT00558012 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2015-07-31

Study results available
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Summary

This trial will examine the safety, efficacy and feasibility of a single dose of intravenous zoledronic acid in the maintenance of skeletal integrity for frail, institutionalized women, who are most at risk for the deleterious outcomes of osteoporosis. The investigators will test the hypothesis that in institutionalized elderly women a single dose of intravenous zoledronic acid therapy will: (1) be efficacious as demonstrated by stability or improvement in bone mass measurements and reductions in bone turnover; (2) be safe and feasible; and (3) provide estimates for vertebral and nonvertebral fracture reduction in this cohort for use in planning a future study.

Conditions

Interventions

DRUG

Intravenous zoledronic acid

Intravenous zoledronic acid 5.0 mg once

DIETARY_SUPPLEMENT

Vitamin D 800 IU/daily

Daily divided dose

DIETARY_SUPPLEMENT

Calcium 1200 mg/daily

supplement plus diet

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Pittsburgh

    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
2007-12-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00558012 on ClinicalTrials.gov