2024-511090-30-00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
Leids Universitair Medisch Centrum (LUMC)1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2024年4月2日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The effect of Denosumab on pain, assessed by the difference in maximum pain score after 6 months (2 injections) by Brief Pain Inventory
研究概览
简要总结
To evaluate the effect of Denosumab on pain, assessed by the difference in maximum pain scores after 6 months (2 injections)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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 Fibrous dysplasia localization, not responding to adequate pain treatment and without mechanical component e.g. impending fracture
- •Pain score from Fibrous dysplasia 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 Na18F-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 Fibrous dysplasia
- •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 severe side effects on Denosumab
- •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
结局指标
主要结局
The effect of Denosumab on pain, assessed by the difference in maximum pain score after 6 months (2 injections) by Brief Pain Inventory
The effect of Denosumab on pain, assessed by the difference in maximum pain score after 6 months (2 injections) by Brief Pain Inventory
次要结局
- To investigate the number of analgesics, use and dosage used at baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months
- To assess the effect of Denosumab on disease activity through laboratory measurements of bone markers at baseline, 3 months and 6 months, and in case of open label treatment after 9 and 12 months
- To assess the effect of Denosumab on lesions activity and lesions size through bone scans at baseline and after 6 months, and in the case of open label treatment after 12 months
- To assess disease quantification by nuclear imaging before and after treatment (Skeletal Burden Score (SBS)
- To assess bone density and the presence of vertebral fractures (Dual-energy X-ray absorptiometry (DXA) + Vertebral Fractures Assessment (VFA) at baseline and after 12 months
- To assess potential side effects in the form of Atypical femoral fractures by performing and extended DXA after 12 months
- To evaluate the effect of Denosumab on average pain scores after 3, 6 months of treatment and in case of open label treatment after 9 and 12 months
- To evaluate the number of patients with 50% reduction of maximal pain (BPI) after 3, 6 months of treatment and in case of open label treatment after 9 and 12 months
- To evaluate the effect of Denosumab on quality of life, assessed with questionaries (SF-36) at baseline, 3 months and after 6 months and in case of open label treatment after 9 and 12 months
- To evaluate the effect of Denosumab on average weekly pain assessed through a pain diary with VAS score
- To investigate the effect of Denosumab on Physical activity assessment (Health Assessment Questionnaire – Disability Index and screenshot of pedometer of activity during the last week on smartphone) measured at baseline, 3 months and 6 months, and in case of open label treatment after 9 and 12 months
- To evaluate the prevalence of possible neuropathic component of the reported pain through Pain Detect questionnaire at baseline, 3 months and 6 months and in case of open label treatment after 9 and 12 months
研究者
Natasha Appelman-Dijkstra
Scientific
Leids Universitair Medisch Centrum (LUMC)
研究点 (1)
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