Effect of denosumab in acute Charcot neuropathic osteoarthropathy on inflammation and on bone health using calcaneal quantitative ultrasound: a phase II randomised controlled trial.

Garvan Institute of Medical Research0 个研究点目标入组 26 人开始时间: 2017年6月28日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•* Pre-existing diagnosis of diabetes mellitus
•* Ambulant
•* Willingness to provide written consent and to participate in study
•* Peripheral neuropathy confirmed with monofilament
•* Acute CN confirmed radiologically, significantly higher temperature in affected foot compared to contralateral foot (greater than 2 degrees Celsius maximal difference), and less than or equal to 3 months since symptoms onset

•* Unable to provide informed consent
•* Previous or planned (within subsequent 18 months) osteotomy or surgical fixation involving the foot
•* Previous or planned (within subsequent 18 months) lower limb amputation above level of ankle
•* Non-weight bearing for greater than 2 month period during past year
•* Antiresorptive therapy during past 12 months, and/or greater than 5 year cumulative exposure
•* Pre-existing diagnosis of peripheral arterial disease, or impalpable pedal pulses
•* Heal ulceration at site of calcaneal quantitative ultrasound probe
•* Other acute foot disease: ulceration (>1A on Texas Classification) or infection
•* Vitamin D deficiency (25-hydroxyvitamin D < 50 nmol/L) if sufficiency cannot be rapidly achieved by supplementation
•* Hypocalcaemia (corrected calcium < 2.10 mmol/L)
•* Active dental infection, invasive dental procedure within preceding 3 months, planned invasive dental procedure within subsequent year, other dental contraindication to antiresorptive therapy
•* Women lactating, pregnant or of childbearing potential not using contraception
•* Life expectancy less than 2 years

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