Clinical Trial: Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: ZEST II for Osteoporotic Fracture Prevention

Brief 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.

Detailed Summary:

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; and
  3. identify baseline characteristics and concomitant bone structure changes associated with a favorable fracture reduction and bone density response to therapy.

To address these hypotheses, up to 1000 female LTC residents age 65 and older will be screened in order to enroll 514 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.


Sponsor: University of Pittsburgh

Current Primary Outcome: total non-traumatic incident clinical fractures (vertebral and nonvertebral) [ Time Frame: 3 years ]

Primary outcome will be assessed in all randomized women, optimally obtaining partial data in terms of person months of exposure and corresponding counts of fractures for analysis from those expiring/dropping out/moving before 3 years.


Original Primary Outcome: total incident clinical fractures (vertebral and nonvertebral) [ Time Frame: 3 years ]

Primary outcome will be assessed in all randomized women, optimally obtaining partial data in terms of person months of exposure and corresponding counts of fractures for analysis from those expiring/dropping out/moving before 3 years.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Pittsburgh

Dates:
Date Received: October 27, 2015
Date Started: January 2016
Date Completion: July 2021
Last Updated: October 5, 2016
Last Verified: October 2016