Clinical trial · Observational
An Observational Study in Patients With Breast Cancer and Bone Metastases Receiving Ibandronate (Bondronat)
A SURVEY TO STUDY THE CORRELATION BETWEEN THE SERUM LEVELS OF BONE TURNOVER MARKERS AND THE CLINICAL PICTURE IN PATIENTS WITH BREAST CANCER AND BONE METASTASES RECEIVING IBRADONIC ACID TREATMENT
- 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 open non-randomized, single-arm, multicenter, observational study is designed to evaluate the correlation between bone turnover markers and the response to treatment in patients with breast cancer and bone metastases. In this observational study, ibandronate (Bondronat) will be prescribed and used in accordance with the standards of care. Data will be collected for 12 months.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Ibandronate
- description
- Patients receiving ibandronate will be evaluated for bone turnover markers for 12 months. Ibandronate is not an investigational medicinal product (IMP) in this study.
Primary outcomes (2)
- measure
- Beta C-terminal telopeptide (B-CTx) level
- timeFrame
- 12 months
- measure
- Treatment response rate
- timeFrame
- 12 months
Secondary outcomes (2)
- measure
- Number of patients who died due to progression of breast cancer
- timeFrame
- 12 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All criteria in accordance with the Summary of Product Characteristics of Bondronat (ibandronate) * Adult patients greater than (\>) 18 years of age * Histologically confirmed breast cancer * Confirmed bone metastasis (by bone scintigraphy, X-ray, computed tomography or magnetic resonance imaging) * Life expectancy \>6 months * No previous bisphosphonate therapy * Patients signed written informed consent form before study start Exclusion Criteria: * All criteria in accordance with the Summary of Product Characteristics of Bondronat(ibandronate) * Hypersensitivity to the active substance or any of the excipients of Bondronat (ibandronate) * Hypersensitivity to bisphosphonates
References
Publications (0)
Data not yet available