NCT02589600

Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)

ZEST II for Osteoporotic Fracture Prevention

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Susan L. Greenspan · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Osteoporotic Fractures
• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-01-01
• Primary completion: 2022-06-22
• Completion: 2022-06-22
• First posted: 2015-10-28
• Last updated: 2023-09-26
• Results posted: 2023-08-16

Locations

1 site across 1 country: United States