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临床试验/NCT00536653
NCT00536653已完成不适用

Long Term Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer, With Stratification of Treatment Based on Presenting Values

Wirral University Teaching Hospital NHS Trust1 个研究点 分布在 1 个国家目标入组 618 人开始时间: 1999年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
618
试验地点
1
主要终点
Peripheral Forearm bone mineral density

研究概览

简要总结

The aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on the bone mineral density of patients.

详细描述

Androgen ablation is the mainstay of treatment for advanced prostate cancer. However,luteinizing hormone-releasing (LHRH) agonists are associated with accelerated bone loss, osteoporosis and fractures. An alternative is the non steroidal antiandrogen, bicalutamide, which acts at the androgen receptor and maintains serum testosterone levels. Our aim was to assess the effects of these two treatments on bone mineral density (BMD) of selected groups of patients, based on their BMD at presentation. All patients will undergo peripheral bone densitometry of the forearm, using dual energy X-ray absorptiometry. Osteoporotic patients, at high risk of fractures, will be commenced on bicalutamide. Osteopenic and normal BMD patients will be commenced on LHRH agonists. All osteopenic and osteoporotic patients will be given calcium and vitamin D supplementation.Patients will undergo annual bone densitometry scans, and will be seen in the clinic every 3 months to monitor well-being and PSA levels. Any patient who fails to respond or escapes treatment with hormone monotherapy will be managed according to the clinical situation by either being switched to a combination of LHRH and bicalutamide or additional oestrogen therapy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
Male
接受健康志愿者

入选标准

  • Patients will locally advanced prostate cancer for whom immediate androgen deprivation was indicated

排除标准

  • Previous systemic therapy for prostate cancer
  • Patients with any illness or medication that would affect bone and mineral metabolism
  • Severe hepatic or renal insufficiency

研究组 & 干预措施

Osteporosis Group

Active Comparator

Patients with a presenting T score < -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD

干预措施: Bicalutamide and Calcium/ Vitamin D supplementation (Drug)

Osteopenia Group

Active Comparator

Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD

干预措施: LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation (Drug)

Normal Group

Active Comparator

Patients with a presenting T score > -1.0(normal BMD), treated with LHRH agonists

干预措施: LHRH agonists (Goserelin acetate) (Drug)

结局指标

主要结局

Peripheral Forearm bone mineral density

时间窗: Over 7 years

次要结局

  • Fractures of the thoracolumbar spine(Over 7 years)

研究者

发起方
Wirral University Teaching Hospital NHS Trust
申办方类型
Other

研究点 (1)

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