ACTRN12624000027516招募中2 期
Romosozumab for Patients with Multiple Myeloma with Skeletal Events on Zoledronic Acid: A Pilot Study
St Vincent's Hospital, Sydney0 个研究点目标入组 12 人开始时间: 2024年1月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Males or females with multiple myeloma
- •Age 18 years or older.
- •Skeletal related event with at least 3 doses of anti-resorptive therapy
- •Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
排除标准
- •History of myocardial infarction or stroke in prior 12 months
- •Women of child bearing potential
- •Active unstable cardiovascular function
- •Previous teriparatide or any parathyroid hormone (PTH) analogs
- •History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Paget’s disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia and malabsorption syndrome
- •Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 50nmol/L. Vitamin D repletion will be permitted and subjects may be rescreened
- •Current hyper- or hypocalcemia
- •Current, uncontrolled hyper- or hypothyroidism
- •Current, uncontrolled hyper- or hypoparathyroidism,
- •History of dental extraction or other invasive dental work within 3 years, or who require invasive dental work within the next two years or history of osteonecrosis of the jaw
- •Life expectancy of less than 2 years.
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
研究者
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