Overview

Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)

Status:
Active, not recruiting
Trial end date:
2023-03-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Susan L. Greenspan
University of Pittsburgh
Collaborators:
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Treatments:
Calcium
Calcium, Dietary
Diphosphonates
Ergocalciferols
Vitamin D
Vitamins
Zoledronic Acid
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).