NCT02564107已完成4 期
An Open Label Study of the Efficacy, Safety, and Pharmacoeconomics of Oral Ibandronate (Bondronat 50 mg) in Treatment of Metastatic Bone Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)
研究概览
简要总结
This study will evaluate the efficacy, safety, and effect on quality of life of oral ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The anticipated time on study treatment is 25 weeks, and the target sample size is 50 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females at least 18 years of age
- •Breast cancer
- •Bone metastases
排除标准
- •Use of bisphosphonates within the last 3 months
- •Prior use of gallium nitrate or metastron
- •Severely impaired renal function
- •Hypocalcemia or primary hyperparathyroidism
- •Central nervous system (CNS) metastases
研究组 & 干预措施
Ibandronate
Experimental
Female participants with metastatic bone disease secondary to breast cancer will receive ibandronate for a period of 25 weeks.
干预措施: Ibandronate (Drug)
结局指标
主要结局
Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)
时间窗: Up to 25 weeks
次要结局
- Incidence of bone pain according to participant questionnaire(Up to 25 weeks)
- Analgesic consumption according to participant questionnaire(Up to 25 weeks)
- Change in serum pyridinoline cross-linked carboxyterminal telopeptide of collagen type I (ICTP)(Up to 25 weeks)
- Short Form 36 (SF-36) score(Up to 25 weeks)
- Incidence of adverse events (AEs)(Up to approximately 7 months)
研究者
相似试验
已完成
3 期
A Study of Ibandronate (Bondronat) in Participants With Malignant Bone DiseasePain; Bone Neoplasms; Neoplasm MetastasisNCT02561039Hoffmann-La Roche97
已完成
2 期
A Long Term Safety Study of BCX7353 in Hereditary AngioedemaHAEProphylaxisHereditary AngioedemaNCT03472040BioCryst Pharmaceuticals387
已完成
4 期
A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal OsteoporosisPost Menopausal OsteoporosisNCT02598934Hoffmann-La Roche308
终止
不适用
A Study to Evaluate the Safety and Efficacy of Apremilast in the Treatment of Skin Disease in Patients With DermatomyositisDermatomyositisNCT01140503Stanford University5
已完成
4 期
A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast CancerPain; Bone Neoplasms; Neoplasm MetastasisNCT02553707Hoffmann-La Roche182