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).