Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)

Osteoporosis, Postmenopausal Clinical Trial

— ZEST II  

Official title:

ZEST II for Osteoporotic Fracture Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589600
• Other study ID #: STUDY19040149 (ZEST II)
• Secondary ID: 1R01AG050302-01A
• Status: Completed
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: June 22, 2022

Study information

• Verified date: September 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Osteoporosis, Postmenopausal
• Osteoporotic Fractures

Intervention

Drug:
• Zoledronic acid
Annual intravenous 5.0 mg

Dietary Supplement:
• vitamin D
800 IU daily
• calcium
approximately 1200 mg (dietary and supplement)

Other:
• Saline
Annual intravenous saline placebo

Locations

Country	Name	City	State
United States	University of Pittsburgh Osteoporosis Prevention & Treatment Center	New Kensington	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Susan L. Greenspan	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years