Efficacy of Sequential Therapies After Osteoanabolic Treatment in Postmenopausal Women With Severe Osteoporosis: the Sequential Treatment After Romosozumab and Teriparatide/Abaloparatide (START) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 14
- 主要终点
- lumbar spine bone mineral density
研究概览
简要总结
12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics
详细描述
Caucasian women with severe postmenopausal osteoporosis who have completed their course with romosozumab or a PTH analog will be assigned to one of the following 3 options: i) zoledronate 5mg infusion or ii) denosumab subcutaneous injections or iii) teriparatide or abaloparatide (for those previously treated with romosozumab) or romosozumab (for those previously treated with teriparatide or abaloparatide).
Endpoints: Primary: BMD changes at the lumbar spine at 12 months. Secondary: i) BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months; ii) changes at levels of bone turnover markers throughout the study; iii) incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide
排除标准
- •a bone disease other than postmenopausal osteoporosis
- •use of medications other than romosozumab or teriparatide affecting bone metabolism during the last 12 months before entering the study
- •creatinine clearance <60 mL/min/1.73 m2
- •liver failure
- •any type of cancer
- •uncontrolled endocrine diseases
- •serum 25-hydroxy vitamin D (25-OHD) concentrations lower than 20 ng/mL (50 nmol/L)
- •hypersensitivity to denosumab or zoledronate or teriparatide or romosozumab or any of the excipients
研究组 & 干预措施
Romo-Zol group
Postmenopausal women treated with romosozumab for 12 months will receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose
干预措施: Zoledronate (Drug)
Romo-Dmab group
Postmenopausal women treated with romosozumab for 12 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months starting at 1 month after the last romosozumab dose
干预措施: Denosumab (Drug)
Romo-PTH group
Postmenopausal women treated with romosozumab for 12 months will receive daily injections of teriparatide 20μg or abaloparatide 80μg for 12 months starting at 1 month after the last romosozumab dose
干预措施: Teriparatide (Drug)
PTH-Zol group
Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 monthswill receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose
干预措施: Zoledronate (Drug)
PTH-Dmab group
Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months
干预措施: Denosumab (Drug)
TPTD-Romo group
Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive month injections of romosozumab for 12 months
干预措施: Romosozumab (Drug)
Romo-PTH group
Postmenopausal women treated with romosozumab for 12 months will receive daily injections of teriparatide 20μg or abaloparatide 80μg for 12 months starting at 1 month after the last romosozumab dose
干预措施: Abaloparatide Injection (80 mcg) (Drug)
结局指标
主要结局
lumbar spine bone mineral density
时间窗: baseline to 12 months
bone mineral density changes at the lumbar spine at 12 months measured by dual-energy absorptiometry (DXA)
次要结局
- total hip bone mineral density(baseline to 12 months)
- femoral neck bone mineral density(baseline to 12 months)
- P1NP(baseline, 3 months, 6 months, 12 months)
- CTx(baseline, 3 months, 6 months, 12 months)
- Fractures(12 months)
研究者
Athanasios D. Anastasilakis
Head of the Department of Endocrinology
424 General Military Hospital