Effects of zoledronic acid after a fragility fracture

Phase 1

• Conditions: on-hip, non-vertebral fragility fracture; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-004766-17-SE
• Lead Sponsor: Region Uppsala

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2900

Inclusion Criteria

1. Willing and able to provide written informed consent
2. Ambulatory (i.e., able to walk without the assistance of another person; canes, walkers, and other assistive devices are permitted)
3. Community dwelling (i.e., living in own home or with friends or relatives)
4. Sustained a non-hip, non-vertebral fragility fracture in the past 2 years
5. Age =65 years at the time of fracture

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2900

Exclusion Criteria

1. History of hip fracture or vertebral compression fracture
2. Undergone bone density scanning since the fragility fracture
3. Severe renal impairment (estimated glomerular filtration rate of <35 ml per minute per 1.73 m2 of body surface area)
4. Remaining life expectancy of <1 year, according the investigator’s judgement
5. Hypocalcemia/hypercalcemia (serum calcium <2.2 or >2.6 mmol/L)
6. Sarcoidosis (contraindication for vitamin D)
7. Previous use of bone-protective drug (e.g., bisphosphonate, teriparatide, denosumab, raloxifene, or strontium ranelate; calcium and vitamin D are acceptable)
8. Use of systemic glucocorticoids at a dose of =5 mg (prednisolone or equivalent) for =3 months in the past year
9. Malabsorption of calcium and/or vitamin D (e.g., due to gastric bypass)
10. Other medication or medical condition for which bone-protective therapy is indicated (e.g., bone metastases or use of aromatase inhibitor; osteoporosis is permitted)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether zoledronic acid reduces the risk of new clinical fractures, as compared with placebo, in older adults with a recent non-hip, non-vertebral fragility fracture;Secondary Objective: To investigate whether zoledronic acid, as compared with placebo:<br><br>1. has a greater effect in reducing the risk of new clinical fractures in women than in men <br>2. reduces the risk of cancer<br>3. reduces the risk of cardiovascular disease (stroke or myocardial infarction)<br>4. reduces the risk of death<br>5. reduces the risk of falling;Primary end point(s): Time to new clinical fracture;Timepoint(s) of evaluation of this end point: 4 and 10 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Time to first non-vertebral fracture<br>2. Time to first new non-hip, non-vertebral fracture<br>3. Time to first hip fracture<br>4. Time to first new forearm fracture<br>5. Time to first clinical vertebral fracture<br>6. Time to death<br>7. Time to first new cardiovascular event (stroke or myocardial infarction)<br>8. Time to first new cancer diagnosis, excluding non-melanoma skin cancer<br>9. Time to first fall from standing height or less not resulting in fracture;Timepoint(s) of evaluation of this end point: 4 and 10 years