CTRI/2010/091/000637已完成4 期
An open label study to evaluate the safety and efficacy of Aclasta (Zoledronic acid) in treatment of patients with Glucocorticoid induced Osteoporosis
ovartis Healthcare Pvt Limited0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- • Male & female patients aged 18?85 years taking atleast 5 mg/d oral prednisone (or equivalent systemic steroid) for at least 3 months prior to screening.
- • T score for bone mineral density at the lumbar spine or total hip of either?1.5 or less with or without fragility fractures
- •New patients or patients who were on other bisphosphonates earlier
- •Aclasta is medically recommended.
- •Willing to participate for 12 months.
- •Patient willing to provide written informed consent to participate in the study, as per local / institutional practice.
排除标准
- •Hypersensitivity to zoledronic acid, to any of the excipients or to any bisphosphonate
- •Females taking more than 30 micrograms/day of estradiol or equivalent in past 3 months
- •Pregnant women or nursing mothers or women of childbearing potential not using adequate contraception
- •Hypocalcemia
- •Renal impairment (calculated creatinine clearance of less than 35 mL/min)
研究者
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