Clinical trial · Interventional
Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients
Phase II Open Label Study to Establish the Safety and Efficacy of Intravenous Loading Dose of Ibandronate 6 mg in 3 Consecutive Days in Breast Cancer Patients With Skeletal Metastases
NCT00381368CI-TRIAL-00000523unknownPhase 2ClinicalTrials.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)
The purpose of the study is to determine the efficacy and safety of a three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients with painful skeletal metastases.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibandronic acid | Drug | Ibandronic Acid | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Worst and average pain in movement and rest on the visual analogue scale (VAS) before the first dose, on days 2, 3, 7 and on day 28
- measure
- Analgesic consumption during the same period will additionally be assessed
Secondary outcomes (3)
- measure
- Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28
- measure
- World Health Organization (WHO) performance status
- measure
- Safety: serum cystatin C and serum creatinine, and reporting of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Breast cancer with presence of bone metastases * Pain score over 4 on the VAS Exclusion Criteria: * Patients with pathological fractures or medulla compression or neuropathic pain * Patients with infection or corticosteroid treatment * Pregnant or lactating patients
References
Publications (0)
Data not yet available
No reference posted for this study.