EUCTR2011-000708-17-BE
进行中（未招募）
不适用
A 24 months, prospective, randomized, double-blind study to assess the effect of daily oral administration of 2 g of strontium ranelate versus placebo on bone mineral density in postmenopausal osteoporotic women previously treated with bisphosphonates
适应症Postmenopausal osteoporotic womenMedDRA version: 14.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
相关药物PROTELOS
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Postmenopausal osteoporotic women
- 发起方
- Institut de Recherches Internationales Servier
- 入组人数
- 160
- 状态
- 进行中（未招募）
- 最后更新
- 10年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Postmenopausal women, aged \> or \= 50 years
- •\- Osteroporotic patients at high risk for fracture
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 40
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 120
排除标准
- •\- Patients with at least one of the following DXA related criteria in reference to the lowest BMD value at any relevant site (L1\-4, total hip, femoral neck):\= \-4\.0 SD T\-score, \> \-1\.5 SD T\-score in patients with prevalent osteoporotic fractures, \> \-2\.0 SD T\-score in patients without prevalent osteoporotic fractures
- •\- Patients with two or more clinical osteoporotic fractures within the last 3 years
- •\-Current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
- •\- Current or previous venous thromboembolism events, including deep vein thrombosis and pulmonary embolism, or patients at high risk of venous thromboembolism.
- •\- Temporary or permanent immobilzation due to e.g. post\-surgical recovery or prolonged bed rest.
- •\- BMI \<18 or \> 32 kg/m²
- •\- Skeletal disease other than primary osteoporosis
- •\- Sarcoidosis
- •\- Phenylketonuria
- •\- Hypersensitivity to the active substance or to any of the excipients, hypersensitivity to soy or peanuts
结局指标
主要结局
未指定
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