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

Roche

Status and phase: Completed; Phase 3

Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis

Treatments: Drug: Ibandronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02561039

ML20713

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Ibandronate IV Infusion

Experimental group

Description:

Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months.

Treatment:

Drug: Ibandronate

Ibandronate PO Tablet

Experimental group

Description:

Participants will receive ibandronate, 50 mg PO daily, for 4 months.

Treatment:

Drug: Ibandronate