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

Institut de Recherches Internationales Servier0 个研究点目标入组 160 人2013年2月6日

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注册库

who.int

开始日期

2013年2月6日

结束日期

待定

最后更新

11年前

研究类型

Interventional clinical trial of medicinal product

性别

Female

发起方

•\- Postmenopausal women, aged \> or \= 50 years
•\- Osteroporotic patients at high risk for fracture previously treated by bisphosphonate for at least 60 months
•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

•\- 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 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
•\- Hereditary fructose intolerance, glucose\-galactose malabsorption, saccharase isomaltase deficiency