EUCTR2011-002370-23-DE进行中（未招募）不适用
A double-blind, multicenter, international randomised study to assess the effects of 4 month-oral administration of 2g per day of strontium ranelate versus placebo on the bone quality and remodelling, as assessed on an alveolar bone biopsy extracted before dental implantation, in osteoporotic patients or in patients at risk of osteoporotic fracture.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Men or post-menopausal women
- •- > or = 50 years
- •- Osteoporotic patient or with a risk of osteoporotic fracture
- •- Eligible for a premolar extraction followed by a dental implant placement
- •- Without inter-radicular septum at extraction
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Pathological findings in the jaw bone
- •- History of maxillar or cervico-facial irradiation
- •- Chronic inflammatory rheumatoid disease
- •- Inflammatory or metabolic bone disease, excluding osteoporosis
- •- Hypersensitivity to the active substances or to any of the excipients or to tetracycline
- •- Current or previous venous thromboembolism events, including deep vein thrombosis and pulmonary embolism, or patients at high risk of venous thromboembolism.
- •- Temporary or permanent immobilization due to e.g. post-surgical recovery or prolonged bed rest.
研究者
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