A Study of Ibandronate (Bondronat) in Participants With Metastatic Bone Disease
- Registration Number
- NCT02564107
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 48
Inclusion Criteria
- Females at least 18 years of age
- Breast cancer
- Bone metastases
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ibandronate Ibandronate Female participants with metastatic bone disease secondary to breast cancer will receive ibandronate for a period of 25 weeks.
- Primary Outcome Measures
Name Time Method Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR) Up to 25 weeks
- Secondary Outcome Measures
Name Time Method 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