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

Primary Purpose

Osteoporotic Fractures, Osteoporosis, Postmenopausal

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zoledronic acid
vitamin D
calcium
Saline
Sponsored by
Susan L. Greenspan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporotic Fractures focused on measuring Bone loss, Frail Geriatric Women, Nursing Home Patients, Long-term Care Patients, Osteoporosis, Osteoporotic Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Pittsburgh Osteoporosis Prevention & Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Medication Group

Placebo Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Non-traumatic Incidental Fractures (Vertebral and Nonvertebral [Identified by X-ray, CT, MRI, VFA Imaging] Per Person-year)
Number of fractures divided by number of person-years. Effectiveness of fracture reduction will be demonstrated by total non-traumatic incidental fractures (vertebral and nonvertebral [identified by x-ray, CT, MRI, VFA imaging) except those viewed as severe trauma (fall from a height higher than a stool or chair or severe trauma other than a fall), cancer-related or fractures of the toes, finger or facial bones.

Secondary Outcome Measures

Full Information

First Posted
October 27, 2015
Last Updated
September 15, 2023
Sponsor
Susan L. Greenspan
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02589600
Brief Title
Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)
Acronym
ZEST II
Official Title
ZEST II for Osteoporotic Fracture Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
June 22, 2022 (Actual)
Study Completion Date
June 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susan L. Greenspan
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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: be effective demonstrated by fracture reduction; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporotic Fractures, Osteoporosis, Postmenopausal
Keywords
Bone loss, Frail Geriatric Women, Nursing Home Patients, Long-term Care Patients, Osteoporosis, Osteoporotic Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Medication Group
Arm Type
Experimental
Arm Description
Annual dose: intravenous zoledronic acid (Reclast) 5.0 mg; vitamin D (800 IU/daily) and calcium (approximately 1200 mg/daily, dietary + supplements)
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Annual dose: intravenous saline; vitamin D (800 IU/daily and calcium (approximately 1200 mg/daily, dietary + supplements)
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Reclast
Intervention Description
Annual intravenous 5.0 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Intervention Description
800 IU daily
Intervention Type
Dietary Supplement
Intervention Name(s)
calcium
Intervention Description
approximately 1200 mg (dietary and supplement)
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Annual intravenous saline placebo
Primary Outcome Measure Information:
Title
Non-traumatic Incidental Fractures (Vertebral and Nonvertebral [Identified by X-ray, CT, MRI, VFA Imaging] Per Person-year)
Description
Number of fractures divided by number of person-years. Effectiveness of fracture reduction will be demonstrated by total non-traumatic incidental fractures (vertebral and nonvertebral [identified by x-ray, CT, MRI, VFA imaging) except those viewed as severe trauma (fall from a height higher than a stool or chair or severe trauma other than a fall), cancer-related or fractures of the toes, finger or facial bones.
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women age ≥65 years including those using assistive devices to maximize generalizability if they: Reside in long-term care (LTC); 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L Greenspan, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Osteoporosis Prevention & Treatment Center
City
New Kensington
State/Province
Pennsylvania
ZIP/Postal Code
15068
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)

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