Clinical trial · Interventional
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
NCT02564107CI-TRIAL-00024650completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain; Bone Neoplasms; Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibandronate | Drug | Ibandronic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ibandronate
- description
- Female participants with metastatic bone disease secondary to breast cancer will receive ibandronate for a period of 25 weeks.
- interventionNames
- Drug: Ibandronate
Primary outcomes (1)
- measure
- Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)
- timeFrame
- Up to 25 weeks
Secondary outcomes (5)
- measure
- Incidence of bone pain according to participant questionnaire
- timeFrame
- Up to 25 weeks
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.