Back to resultsA Study of Ibandronate (Bondronat) in Participants With Metastatic Bone Disease
Primary Purpose
Pain; Bone Neoplasms; Neoplasm Metastasis
Status
Completed
Phase
Phase 4
Locations
Bulgaria
Study Type
Interventional
Intervention
Ibandronate
Sponsored by
About this trial
This is an interventional treatment trial for Pain; Bone Neoplasms; Neoplasm Metastasis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ibandronate
Arm Description
Female participants with metastatic bone disease secondary to breast cancer will receive ibandronate for a period of 25 weeks.
Outcomes
Primary Outcome Measures
Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)
Secondary Outcome Measures
Incidence of bone pain according to participant questionnaire
Analgesic consumption according to participant questionnaire
Change in serum pyridinoline cross-linked carboxyterminal telopeptide of collagen type I (ICTP)
Short Form 36 (SF-36) score
Incidence of adverse events (AEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02564107
Brief Title
A Study of Ibandronate (Bondronat) in Participants With Metastatic Bone Disease
Official Title
An Open Label Study of the Efficacy, Safety, and Pharmacoeconomics of Oral Ibandronate (Bondronat 50 mg) in Treatment of Metastatic Bone Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain; Bone Neoplasms; Neoplasm Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibandronate
Arm Type
Experimental
Arm Description
Female participants with metastatic bone disease secondary to breast cancer will receive ibandronate for a period of 25 weeks.
Intervention Type
Drug
Intervention Name(s)
Ibandronate
Other Intervention Name(s)
Bondronat
Intervention Description
Participants will receive ibandronate, 50 milligrams (mg) by mouth every morning, for a period of 25 weeks.
Primary Outcome Measure Information:
Title
Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)
Time Frame
Up to 25 weeks
Secondary Outcome Measure Information:
Title
Incidence of bone pain according to participant questionnaire
Time Frame
Up to 25 weeks
Title
Analgesic consumption according to participant questionnaire
Time Frame
Up to 25 weeks
Title
Change in serum pyridinoline cross-linked carboxyterminal telopeptide of collagen type I (ICTP)
Time Frame
Up to 25 weeks
Title
Short Form 36 (SF-36) score
Time Frame
Up to 25 weeks
Title
Incidence of adverse events (AEs)
Time Frame
Up to approximately 7 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
City
Shumen
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
City
Stara Zagora
ZIP/Postal Code
8000
Country
Bulgaria
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
12. IPD Sharing Statement
Learn more about this trial
A Study of Ibandronate (Bondronat) in Participants With Metastatic Bone Disease
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