ISRCTN48348637已完成3 期
SOTI and TROPOS phase III studies open-label extension. The long term efficacy and long term safety assessment of a five-year oral administration of strontium ranelate in osteoporotic postmenopausal women having participated either in Spinal Osteoporosis Therapeutic Intervention SOTI study or TReatment Of Peripheral OSteoporosis TROPOS study. A five-year multicentric multinational open study with strontium ranelate.
Institut de Recherches Internationales Servier (France)0 个研究点目标入组 3,000 人开始时间: 2008年5月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
研究概览
简要总结
2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22124575
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Caucasian women
- •2. Postmenopausal
- •3. Osteoporosis
- •4. Having participated up to the SOTI or TROPOS M060 visit or withdrawn under study treatment from the SOTI or TROPOS study within a 6-month period preceding the theoretical M060 visit
排除标准
- •1. Patients having attended the M060 or withdrawn SOTI-TROPOS visit at a time greater than one year prior to the inclusion visit of the CL3-12911-012 protocol
- •2. Significant concomitant disease (evolutive major illnesses)
- •3. Severe disease interfering with bone metabolism
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