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临床试验/NCT00493532
NCT00493532No Longer Available不适用

An Open Label Study to Evaluate the Effect on Bone Mineral Density, and the Safety, of Quarterly Intravenous Bonviva in Patients With Post-menopausal Osteoporosis.

Hoffmann-La Roche0 个研究点开始时间: 2007年6月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
No Longer Available

研究概览

简要总结

This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

研究设计

研究类型
Expanded Access

入排标准

年龄范围
— 至 80 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • post-menopausal women with osteoporosis;
  • <=80 years of age;
  • naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for >1 year.

排除标准

  • metabolic bone disease other than post-menopausal osteoporosis;
  • treatment with other drugs affecting bone metabolism within last 6 months;
  • previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).

研究者

申办方类型
Industry
责任方
Sponsor

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