ISRCTN59279012已完成3 期
The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D insufficiency in the treatment of osteoporotic postmenopausal women and men. A prospective, international phase III study with a 6-month double-blind period to assess the efficacy and safety of a daily oral administration of S06911 versus S12911 (strontium ranelate 2g) and a 6-month open-labelled extension for a subgroup of patients to assess safety of a daily oral administration of S06911.
Institut de Recherches Internationales Servier (France)0 个研究点目标入组 500 人开始时间: 2010年5月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
研究概览
简要总结
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24322182
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Osteoporotic men and osteoporotic post-menopausal women
- •2. Age superior or equal 50 years, either sex
- •3. Caucasian
- •4. 25-OH vitamin D3 serum concentration greater than 22.5 nmol/
排除标准
- •1. Progressive major illness, uncontrolled active disease, skeletal disease
- •2. History or increased risk of deep venous thrombosis or pulmonary embolism
- •3. History of intolerance, allergy or severe hypersensitivity with study drugs
研究者
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