Clinical trial · Interventional
Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain
- 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)
RATIONALE: Ibandronate may be effective in reducing bone pain caused by metastatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether ibandronate is more effective than standard treatment with radiation therapy in treating metastatic bone pain. PURPOSE: This phase III randomized clinical trial is studying ibandronate to see how well it works compared to single-dose local radiation therapy in treating patients with localized metastatic bone pain.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Pain | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ibandronate sodium | Drug | Ibandronic Acid | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary prostate cancer OR sclerotic bone metastases (for patients with serum prostate-specific antigen \> 100 ng/mL) * Radiologically confirmed bone metastases by plain x-ray, isotope scan, CT scan, or MRI * Clinical diagnosis of metastatic bone pain for which radiotherapy is indicated * Single localized metastatic bone pain AND receiving optimal analgesics and adjuvant drugs, including non-steroidal anti-inflammatory drugs, unless contraindicated * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * Over 18 Sex * Male Menopausal status * Not specified Performance status * Not specified Life expectancy * At least 3 months Hematopoietic * Not specified Hepatic * Not specified Renal * Creatinine ≤ 3.0 mg/dL * No hypercalcemia (corrected calcium \> 10.8 mg/dL) * No hypocalcemia (corrected calcium \< 8.2 mg/dL) Other * No known hypersensitivity to ibandronate or other bisphosphonates * No history of aspirin-sensitive asthma * Able to comply with pain chart and quality of life assessments PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 4 weeks since prior change in systemic chemotherapy * No prior high-dose chemotherapy (dose intensity \> 3 times standard dose) Endocrine therapy * More than 4 weeks since prior change in hormonal therapy Radiotherapy * See Disease Characteristics * No prior external beam radiotherapy to index site * No prior systemic radioisotope therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium) Surgery * Not specified Other * More than 6 months since prior bisphosphonate treatment * More than 4 weeks since prior aminoglycoside antibiotics * More than 30 days since prior investigational drugs
References
Publications (0)
Data not yet available