Phase 4
N=310
Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)
Osteoporotic Fractures · Osteoporosis, Postmenopausal
Bottom Line
View on ClinicalTrials.gov: NCT02589600 ↗Enrolled (actual)
310
Serious AEs
49.4%
Results posted
Aug 2023
Primary outcome: Primary: Non-traumatic Incidental Fractures (Vertebral and Nonvertebral [Identified by X-ray, CT, MRI, VFA Imaging] Per Person-year) — 1.06093; 1.01563 Fractures per person-year — p=0.7251
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Zoledronic acid (Drug); vitamin D (Dietary_supplement); calcium (Dietary_supplement); Saline (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- Female
- Sponsor
- Susan L. Greenspan
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-traumatic Incidental Fractures (Vertebral and Nonvertebral [Identified by X-ray, CT, MRI, VFA Imaging] Per Person-year) |
1.06093; 1.01563 | 0.7251 |
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.
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).
Data sourced from ClinicalTrials.gov (NCT02589600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.