A Study of Ibandronate (Bondronat) in Participants With Metastatic Bone Disease
An Open Label Study of the Efficacy, Safety, and Pharmacoeconomics of Oral Ibandronate (Bondronat 50 mg) in Treatment of Metastatic Bone Disease
1 other identifier
interventional
48
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2004
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
September 30, 2015
CompletedNovember 2, 2016
November 1, 2016
1.4 years
September 28, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)
Up to 25 weeks
Secondary Outcomes (5)
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
Study Arms (1)
Ibandronate
EXPERIMENTALFemale participants with metastatic bone disease secondary to breast cancer will receive ibandronate for a period of 25 weeks.
Interventions
Participants will receive ibandronate, 50 milligrams (mg) by mouth every morning, for a period of 25 weeks.
Eligibility Criteria
You may qualify if:
- Females at least 18 years of age
- Breast cancer
- Bone metastases
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Plovdiv, 4004, Bulgaria
Unknown Facility
Shumen, Bulgaria
Unknown Facility
Sofia, 1527, Bulgaria
Unknown Facility
Sofia, 1756, Bulgaria
Unknown Facility
Sofia, 1784, Bulgaria
Unknown Facility
Stara Zagora, 8000, Bulgaria
Unknown Facility
Varna, 9010, Bulgaria
Unknown Facility
Veliko Tarnovo, 5000, Bulgaria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2015
First Posted
September 30, 2015
Study Start
November 1, 2004
Primary Completion
April 1, 2006
Study Completion
April 1, 2006
Last Updated
November 2, 2016
Record last verified: 2016-11