Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal Metastasis

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients with lung cancer and bone metastatic disease may experience moderate or severe bone pain. Some researches have reported that loading doses Bondronat (6mg Bondronat on three consecutive days) had great efficacy in reducing pain in patients with malignant bone disease without unacceptable toxicities. So,we designed this clinical trial to compare the efficacy and safety profiles between loading doses Bondronat and standard dose Bondronat.Enrolled patients will receive an intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day. The targeted sample size is 120 individuals. Primary outcome measures will be bone pain response ( ≥ 25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption). Secondary outcome measures will be efficacy including ECOG Performance status, analgesic consumption, bone markers, and safety profiles including AE and laboratory parameters.

Official Title
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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

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Ibandronate (Bondronat)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Intravenous infusion of either 6mg Bondronat on three consecutive days | Drug: Ibandronate (Bondronat)<br>* Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.<br>* Other names: no other names;|
| Active Comparator: B<br>Intravenous infusion of 6mg Bondronat on one day | Drug: Ibandronate (Bondronat)<br>* Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.<br>* Other names: no other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ibandronate, Lung cancer, bone metastasis