Clinical trial · Interventional
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.
An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Bone Pain in Patients With Breast Cancer and Skeletal Metastases
- 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 single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is 3 months, and the target sample size is \<100 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 [Bondronat] | Drug | Ibandronic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: ibandronate [Bondronat]
Primary outcomes (1)
- measure
- Pain and analgesic consumption
- timeFrame
- Days 1, 7 and 14
Secondary outcomes (3)
- measure
- AEs and laboratory parameters
- timeFrame
- Days 1, 4 and 7
- measure
- Serum creatinine
- timeFrame
- Days 1, 4 and 7
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * female patients, \>=18 years of age; * breast cancer; * bone metastases; * moderate to severe pain; * adequate renal function. Exclusion Criteria: * bisphosphonate treatment within 3 weeks of study enrollment.
References
Publications (0)
Data not yet available