A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease

Study Overview
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Brief Summary
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This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky Performance Index (KPI) will be measured at intervals throughout the study. The anticipated time on study treatment is 4 months and the target sample size is 150 individuals.

Official Title
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Randomized, Open Label Study to Assess the Efficacy and Safety of the Intravenous and Oral Ibandronic Acid for Improving the Performance Status of Patients With Malignant Bone Disease Secondary to Solid Tumors and Hematological Malignancies

Conditions
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Pain; Bone Neoplasms; Neoplasm Metastasis

Intervention / Treatment
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* Drug: Ibandronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults at least 18 years of age Malignant bone disease due to multiple myeloma or cancer of the lung, prostate, gastrointestinal (GI) tract, ovary, or bladder Bone pain defined as a Brief Pain Inventory (BPI) most acute pain score greater than or equal to 4 Radiologically confirmed bone disease disease Exclusion Criteria: Previous treatment with ibandronate (Bondronat) within previous 2 months Severely impaired renal function Known brain metastases

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: Ibandronate IV Infusion<br>Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months. | Drug: Ibandronate<br>* Participants will receive ibandronate, either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily, for 4 months.<br>* Other names: Bondronat;|
| Experimental: Ibandronate PO Tablet<br>Participants will receive ibandronate, 50 mg PO daily, for 4 months. | Drug: Ibandronate<br>* Participants will receive ibandronate, either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily, for 4 months.<br>* Other names: Bondronat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate according to reduction in BPI most acute pain score from Baseline |  | Month 4 | 
| Change in KPI |  | Baseline to Month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of decrease in most acute pain score |  | Up to 4 months | 
| Analgesic consumption according to participant diary |  | Up to 5 months | 
| Incidence of adverse events |  | Up to 5 months |