Clinical Trials Logo

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
First received
Last updated
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
Health authority
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).

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03931109 - Circulating miRNA in Primary Hyperparathyroidism
Not yet recruiting NCT03232476 - Effect of Mechanical Loading With PTH on Cortical Bone Phase 4
Completed NCT02884401 - Peri-implant Bone Changes in Post-menopausal Osteoporotic Women N/A
Completed NCT00073190 - Patient- and Physician-Based Osteoporosis Education Phase 1
Completed NCT00402441 - Risedronate in the Prevention of Osteoporosis in Postmenopausal Women Phase 4
Completed NCT03710889 - Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption Phase 3
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Recruiting NCT05058976 - Romosozumab Use to Build Skeletal Integrity Phase 4
Active, not recruiting NCT05405894 - Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
Recruiting NCT03337971 - Nutritional Supplement and Bone Health in Post-Menopausal Women N/A
Completed NCT03701113 - Milk Protein and Bone Health in Postmenopausal Women N/A
Completed NCT01381588 - The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women N/A
Completed NCT00383422 - Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis Phase 3
Completed NCT00549965 - Satisfaction and Compliance of Risedronate in PMO Phase 4
Completed NCT00035256 - Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis Phase 4
Completed NCT01386281 - Julina Post-marketing Surveillance for Climacteric Symptoms in Japan
Completed NCT05266261 - Use of Ibandronate in Diabetic Patients N/A
Recruiting NCT04964388 - Effect of GLP-1 Receptor Agonists on Trabecular Bone Score Phase 2
Active, not recruiting NCT03623633 - Comparative Antiresorptive Efficacy Discontinuation of Denosumab Phase 4
Recruiting NCT05575167 - Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)