Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2022-06-22

Brief Summary

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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.

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Detailed Description

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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

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Osteoporotic Fractures Osteoporosis, Postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active Medication Group

Annual dose: intravenous zoledronic acid (Reclast) 5.0 mg; vitamin D (800 IU/daily) and calcium (approximately 1200 mg/daily, dietary + supplements)

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Annual intravenous 5.0 mg

vitamin D

Intervention Type DIETARY_SUPPLEMENT

800 IU daily

calcium

Intervention Type DIETARY_SUPPLEMENT

approximately 1200 mg (dietary and supplement)

Placebo Group

Annual dose: intravenous saline; vitamin D (800 IU/daily and calcium (approximately 1200 mg/daily, dietary + supplements)

Group Type PLACEBO_COMPARATOR

vitamin D

Intervention Type DIETARY_SUPPLEMENT

800 IU daily

calcium

Intervention Type DIETARY_SUPPLEMENT

approximately 1200 mg (dietary and supplement)

Saline

Intervention Type OTHER

Annual intravenous saline placebo

Interventions

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Zoledronic acid

Annual intravenous 5.0 mg

Intervention Type DRUG

vitamin D

800 IU daily

Intervention Type DIETARY_SUPPLEMENT

calcium

approximately 1200 mg (dietary and supplement)

Intervention Type DIETARY_SUPPLEMENT

Saline

Annual intravenous saline placebo

Intervention Type OTHER

Other Intervention Names

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Reclast

Eligibility Criteria

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Inclusion Criteria

* women age ≥65 years including those using assistive devices to maximize generalizability if they:

1. Reside in long-term care (LTC);
2. Have:

* osteoporosis by axial bone density (spine, hip or forearm bone mineral density (BMD) T-score ≤ -2.5 SD); or
* a previous adult fragility fracture of the spine or hip; or,
* would be treated based on FRAX National Osteoporosis Foundation (NOF) treatment thresholds of a 10 year risk of ≥ 20% for a major osteoporotic fracture or ≥ 3% for hip fracture using femoral neck BMD.

Exclusion Criteria

* Men because osteoporosis is less common in men and our initial ZEST 1 study only included women.
* Institutionalized women with subacute illnesses surviving or discharged in \< 3 years.
* Women currently on bisphosphonate, denosumab, or teriparatide therapy or who have been on a bisphosphonate for greater than 1 year during the previous 2 years because bisphosphonates are long acting.
* Patients with a calculated creatinine clearance \< 35 ml/min or who have a contraindication for bisphosphonates (allergy, hypocalcemia).

Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No