Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)

NCT02589600 | Completed Phase 4 Results DMC

• 2 other identifiers: STUDY19040149 (ZEST II)1R01AG050302-01A1
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporotic Fractures; Osteoporosis, Postmenopausal

Keywords

Bone loss; Frail Geriatric Women; Nursing Home Patients; Long-term Care Patients; Osteoporosis; Osteoporotic Fractures

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Active Medication Group

EXPERIMENTAL

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

Drug: Zoledronic acid; Dietary Supplement: vitamin D; Dietary Supplement: calcium

Placebo Group

PLACEBO COMPARATOR

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

Dietary Supplement: vitamin D; Dietary Supplement: calcium; Other: Saline

Interventions

Zoledronic acid DRUG

Annual intravenous 5.0 mg

Also known as: Reclast

Active Medication Group

vitamin D DIETARY_SUPPLEMENT

800 IU daily

Active Medication Group; Placebo Group

calcium DIETARY_SUPPLEMENT

approximately 1200 mg (dietary and supplement)

Active Medication Group; Placebo Group

Saline OTHER

Annual intravenous saline placebo

Placebo Group

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Susan L. Greenspan: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh Osteoporosis Prevention & Treatment Center

New Kensington, Pennsylvania, 15068, United States

Location

MeSH Terms

Conditions

Osteoporotic Fractures; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Osteoporosis

Interventions

Zoledronic Acid; Vitamin D; Calcium; Sodium Chloride

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Results Point of Contact

• Title: Susan Greenspan
• Organization: University of Pittsburgh

greenspn@pitt.edu

4126922477

Study Officials

• Susan L Greenspan, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 28, 2015
• Study Start: January 1, 2016
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: September 26, 2023
• Results First Posted: August 16, 2023

Record last verified: 2023-09

Locations

US (1)