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

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ClinicalTrials.gov Identifier: NCT02589600
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : September 6, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Susan L. Greenspan, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Osteoporotic Fractures Osteoporosis, Postmenopausal Drug: Zoledronic acid Dietary Supplement: vitamin D Dietary Supplement: calcium Other: Saline Phase 4

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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 514 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: ZEST II for Osteoporotic Fracture Prevention
Study Start Date : January 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Drug: Zoledronic acid
Annual intravenous 5.0 mg
Other Name: Reclast

Dietary Supplement: vitamin D
800 IU daily

Dietary Supplement: calcium
approximately 1200 mg (dietary and supplement)

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

Dietary Supplement: calcium
approximately 1200 mg (dietary and supplement)

Other: Saline
Annual intravenous saline placebo




Primary Outcome Measures :
  1. Total non-traumatic incident fractures (vertebral and nonvertebral) except those viewed as severe trauma, cancer-related or fractures of the toes, finger or facial bones as identified by x-ray, CT, MRI, VFA imaging. [ 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589600


Contacts
Contact: Julie M Wagner, PA-C, MPA 412-692-2478 wagnerjm@pitt.edu
Contact: Dory Adams, MFA 412-692-2480 dja21@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Osteoporosis Prevention & Treatment Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Julie Wagner, PA-C, MPA    412-692-2478    wagnerjm@pitt.edu   
Contact: Dory Adams, MFA    412-692-2480    dja21@pitt.edu   
Principal Investigator: Susan L Greenspan, MD         
Sponsors and Collaborators
Susan L. Greenspan
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
Principal Investigator: Susan L Greenspan, MD University of Pittsburgh

Responsible Party: Susan L. Greenspan, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02589600     History of Changes
Other Study ID Numbers: PRO15070573 (ZEST II)
1R01AG050302-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Keywords provided by Susan L. Greenspan, University of Pittsburgh:
Bone loss
Frail Geriatric Women
Nursing Home Patients
Long-term Care Patients
Osteoporosis
Osteoporotic Fractures

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Osteoporosis, Postmenopausal
Osteoporotic Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Zoledronic acid
Calcium, Dietary
Diphosphonates
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents