The effects of pubertal induction on bone health in children with neuromuscular conditions

Murdoch Childrens Research Institute0 个研究点目标入组 58 人开始时间: 2019年10月8日最近更新: 2019年10月14日

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•Participants will include girls 13 years and over, and boys 14.5 years and older, who have not reached puberty as defined by onset of breast development in girls, testicular enlargement in boys >4ml , with associated and continuing changes in feminization or virilisation over at least 6 months and who have one of the following conditions
•1)Spinal muscular atrophy Types 2 & 3
•2)Cerebral palsy with a level 4 or 5 on the Gross Motor Function Classification System (GMFCS)
•3)Muscular dystrophies other than Duchenne (eg Becker) and congenital myopathies
•(eg. Nemaline )

•Children who
•Have Duchenne Muscular Dystrophy (because of corticosteroid use interferes with pubertal onset and progress)
•Are currently participating in other trials because altered pubertal status is likely to affect other care aspects in many areas
•Are using or have prior use of bisphosphonates or other bone modifying drugs
•Have used corticosteroids for the last 12 months
•Has active or completed puberty
•Have a contraindication to Androgens (Testogel®) or oestrogens (Climara®) use due to a severe pro-coagulopathic disorder or medication allergies
•Have vertebral fractures greater than Genant 3 found on back x-ray at screening or 6 months prior as this will require bisphosphonate treatment
•Previous incidences of deep vein thrombosis, clots or stroke
•Older than 18 years of age

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