Clinical trial · Interventional
Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal Metastasis
A Randomized Study to Evaluate the Safety and Efficacy of Loading Dose of Bondronat Versus Standard Dose of Bondronat in Patients With Lung Cancer and Skeletal Metastasis Experiencing Moderate to Severe Pain
NCT00492843CI-TRIAL-00020931terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): It is too difficult to recruit suitable patients.
Summary
Brief summary (as posted)
The objective of this trial is to assess the efficacy and safety of loading doses versus standard dose of intravenous Bondronat in reducing pain in patients with lung cancer and bone metastatic disease.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibandronate (Bondronat) | Drug | Ibandronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Intravenous infusion of either 6mg Bondronat on three consecutive days
- interventionNames
- Drug: Ibandronate (Bondronat)
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Intravenous infusion of 6mg Bondronat on one day
- interventionNames
- Drug: Ibandronate (Bondronat)
Primary outcomes (1)
- measure
- bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption)
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Age ≥ 18 years * Histological or cytological evidence of lung cancer * Presence of bone metastases documented on bone X-ray, bone ECT, CT scan or MRI scan * Mean pain score ≥ 4 during 3-day baseline period on the WORSE pain scale of the VAS * Patients must be on a stable dose of analgesics over the 3-day baseline period (maximum 15% variation is allowed) * ECOG Performance status of 0-3 (patients with PS of 3 must have their score based on bone pain, not underlying neoplastic disease) * Adequate renal function: creatinine clearance ≥ 50 ml/min (cockroft formula) and serum creatinine ≤ 2.0mg/dl (168 µmol/L); ALT or AST within 2 times the upper limit of the normal range Exclusion Criteria: * Patients with an uncontrolled infection * Hypocalcemia * Patients who have received a bisphosphonate within 3 weeks of the start of the Baseline period or who are currently receiving another bisphosphonate * Patients with known hypersensitivity to any of the components of ibandronic acid * Patients who are pregnant or lactating * Radiotherapy to bone within the 28 days prior inclusion or during the trial duration * Patient who are currently treated with any other investigational therapy or have received it within 30 days of the first schedule day of dosing
References
Publications (0)
Data not yet available
No reference posted for this study.