Effect of an annual infusion of zoledronate on bone mineral density in patients on long term follow up with cancer remission and anti-neoplastic treatment induced bone loss study

niversity of Sheffield (UK)0 个研究点目标入组 80 人开始时间: 2010年6月30日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Histologically proven malignant disease
•2. Complete response of primary disease to chemotherapy and/or radiotherapy and no evidence of metastases
•3. Osteoporosis or osteopaenia (as defined by World Health Organization [WHO] criteria) at screening dual energy x-ray absorptiometry (DEXA) scan
•4. Confirmation of post-menopausal status (female patients) as determined by serum follicle-stimulating hormone (FSH) greater than 15 mU/ml and oestradiol levels of less than 30 pg/ml
•5. Aged 18 years or above
•6. Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2
•7. No previous treatment with bisphosphonate
•8. No treatment with anabolic steroids, fluoride, calcitonin or vitamin D within the last six months
•9. No change in endocrine therapy in last three months
•10. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
•11. Written informed consent

•1. Abnormal renal function (serum creatinine level greater than 130 µM/L or greater than 1.5 mg/dL)
•2. Pregnancy/lactation (female patients)
•3. Other disorders of bone metabolism e.g., Paget's disease, hyperparathyroidism, renal osteodystrophy

发起方

niversity of Sheffield (UK)