DEnosumab for the treatment of FIbrous Dysplasia/McCune-Albright Syndrome in adults (DeFiD): a randomized double-blind placebo-controlled trial

eids Universitair Medisch Centrum (LUMC)0 个研究点目标入组 82 人开始时间: 2024年3月15日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•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

•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

发起方

eids Universitair Medisch Centrum (LUMC)