DRKS00026630招募中未知
Dietary Intervention with Maritime Pine Bark Extract Pycnogenol® to Reveal the Course of Bone Loss in Osteopenia and clinically stable Osteoporosis - PROtectO
Klinische StudieneinheitOrthopädische Klinik, Universität Würzburg0 个研究点目标入组 76 人开始时间: 2021年9月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 99 Years（—）
- 性别
- All
入选标准
- •Males / females, age = 18 years
- •- Increased 10-year fracture risk =20 % according to the National German Guidelines for Diagnosis and
- •Treatment of Osteoporosis for postmenopausal women and men = 60 years of age
- •- DXA T-Score = -1,0 at either total hip, femoral neck or lumbar spine
- •- Signed informed consent
排除标准
- •- Current / ongoing treatment with bisphosphonates, denosumab, strontium ranelate, teriparatide,
- •odanacatib or romosozumab
- •- Osteoporotic fracture within 3 months prior to enrollment
- •- Given medical indication for treatment with bisphosphonates, denosumab, strontium ranelate, teriparatide,
- •odanacatib or romosozumab according to applicable national guidelines with the following
- •exceptions:
- •* Participant refuses to take such medication
- •* Participant cannot be treated due to contraindications or an unfavorable risk/benefit ratio
- •* Participant was previously treated with such medication and is now pausing is considered to
- •avoid long-term treatment associated side-effects
- •- Use of nutritional supplements
研究者
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