NL-OMON53469招募中4 期
DEnosumab for the treatment of FIbrous Dysplasia/McCune-Albright Syndrome in adults (DeFiD): a randomized double-blind placebo-controlled trial - DeFiD
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Being symptomatic with an established diagnosis of FD/MAS and closed growth
- •plates (>18 years)
- •- Pain in the region of an FD localization, not responding to adequate pain
- •treatment and
- •without mechanical component e.g. impending fracture
- •- Pain score from FD lesion for maximum or average pain on VAS >= 4
- •- Increased lesional activity defined as increased bone turnover markers (ALP,
- •P1NP or CTX) or increased activity on Na[18F]-PET/CT or bone scintigraphy in at
- •least one lesion
- •- Normal levels of calcium, parathyroid hormone and vitamin D (supplementation
- •is allowed)
- •- Treated hypophosphatemia (defined as >0.7 at two separate measures)
- •- good dental health (last check within the last 12 months)
排除标准
- •- Active pregnancy wish, pregnancy or nursing
- •- Pain not related to FD
- •- Uncontrolled endocrine disease
- •- Untreated vitamin D deficiency, hypocalcemia or hypophosphatemia
- •- Previous use of bisphosphonates or Dmab < 6 months before inclusion (*6
- •months wash out*)
- •- Previously reported side effects on Dmab
- •- Inability to fulfil study requirements
- •- Poor untreated dental health without intention to get treatment
- •- Treatment with other bone influencing drugs, such as high doses
- •corticosteroids
研究者
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