CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 181 enrolled
Drug / intervention
Intravenous zoledronic acid +2 moredrug
Likely dose
Vitamin D 800 IU/dailyfrom 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/NCT00558012
NCT00558012N/ACompleted

Maintenance of Skeletal Integrity in Frail Elders

University of Pittsburgh·interventional·Posted Nov 14, 2007·Updated Jul 31, 2015

In Brief

A clinical study evaluating Intravenous zoledronic acid, Vitamin D 800 IU/daily, and 1 other intervention for Osteoporosis and 2 related conditions. Completed, enrolled 181 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 14, 2007
Enrollment StartDec 1, 2007
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 18.6 years ago

Interventions

Intravenous zoledronic aciddrug

Intravenous zoledronic acid 5.0 mg once

Vitamin D 800 IU/dailydietary

Daily divided dose

Calcium 1200 mg/dailydietary

supplement plus diet