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Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II) — ZEST II  

Osteoporosis, Postmenopausal Clinical Trial

Official title:
ZEST II for Osteoporotic Fracture Prevention

Clinical Trial 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.

Clinical Trial Description

Although close to 85% of frail women in long-term care (LTC) facilities have osteoporosis and the risk of osteoporotic fractures is nearly 10 times that of community dwelling elderly, few are treated and studies are scarce. It is postulated that in frail, LTC women an annual infusion of zoledronic acid, an antiresorptive therapy for osteoporosis, will: 1. be effective demonstrated by fracture reduction; 2. be safe. To address these hypotheses, up to 1000 female LTC residents age 65 and older will be screened in order to enroll 310 eligible for randomization in a 3 year, randomized, double-blind, calcium and vitamin D controlled trial with the antiresorptive agent zoledronic acid. Use of an intravenous, once yearly agent avoids concerns of oral bisphosphonate side effects, poor absorption and burden on staff. Participants will reside in the long-term care settings associated with the Division of Geriatric Medicine, University of Pittsburgh and will include women with multiple comorbid conditions, functional and cognitive impairment, and limited mobility. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02589600
Study type Interventional
Source University of Pittsburgh
Contact
Status Completed
Phase Phase 4
Start date January 2016
Completion date June 22, 2022
View Details
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