NCT00909961已完成3 期
A One Year, Local, Open Label, Multicentre Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on BMD and Biochemical Markers of Bone in PMO Pts Between the Ages of 50 and 65 Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Efficacy - BMD
研究概览
简要总结
This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical markers of bone in post-menopausal osteoporotic patients aged between 50-65.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal osteoporosis
- •Patients who has a low bone mineral density at hip or vertebral
- •Patients who has an osteoporotic fracture at hip or vertebra
排除标准
- •Hypersensitivity either to the active substance or to any of the excipients or to any biphosphonates.
- •Known metabolic bone disease excluding osteoporosis.
- •Serious systemic disorder treated with drugs interfering with bone metabolism.
- •Significant liver or renal failure
- •Pathologic fracture in the examined body area or elsewhere.
- •Previous anti-osteoporotic treatment within 12 months or less prior to the recruitment.
- •Patients with hypocalcaemia
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Zoledronic acid
Experimental
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
Efficacy - BMD
时间窗: 1 year
次要结局
- Efficacy - Biochemical markers(6 months)
- Safety - Rate of adverse events and serious adverse events(6 months)
研究者
研究点 (2)
Loading locations...
相似试验
终止
3 期
Zoledronic Acid in MS-patients With OsteoporosisMultiple SclerosisOsteoporosisNCT01166178Novartis29
已完成
3 期
Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal TherapyBreast NeoplasmsOsteoporosisNCT00050011Novartis Pharmaceuticals602
已完成
3 期
Efficacy and Safety of Zoledronic Acid in Patients With Bone Metastases of Any Solid Tumors or Multiple MyelomaTreatment of Bone MetastasesNCT00219258Novartis240
已完成
3 期
Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With OsteoporosisOsteoporosisNCT00404820Novartis604
已完成
4 期
Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone MetastasesNeoplasm MetastasisNCT00434317Novartis80