The Fragility Fracture Trial (FFT): A randomized, double-blind, placebo-controlled trial to investigate whether zoledronic acid prevents new fractures in older adults with a recent non-hip, non-vertebral fragility fracture - Fragility Fracture Trial (FFT)

Region Uppsala0 个研究点目标入组 2,900 人开始时间: 2020年12月7日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•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)

发起方

Region Uppsala