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

Phase 3

Completed

• Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis
• Interventions: Drug: Ibandronate

• Registration Number: NCT02561039
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-25
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

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Exclusion Criteria

• Previous treatment with ibandronate (Bondronat) within previous 2 months
• Severely impaired renal function
• Known brain metastases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibandronate IV Infusion	Ibandronate	Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months.
Ibandronate PO Tablet	Ibandronate	Participants will receive ibandronate, 50 mg PO daily, for 4 months.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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