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

Hoffmann-La Roche97 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain; Bone Neoplasms; Neoplasm Metastasis

Interventions

IbandronateDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Unnamed facility

Burgas, Bulgaria

Unnamed facility

Haskovo, Bulgaria

Unnamed facility

Pleven, Bulgaria

Unnamed facility

Plovdiv, Bulgaria

Outcomes

Primary Outcomes

Response rate according to reduction in BPI most acute pain score from Baseline

Time frame: Month 4

Change in KPI

Time frame: Baseline to Month 4

Secondary Outcomes

Time to onset of decrease in most acute pain score

Time frame: Up to 4 months

Analgesic consumption according to participant diary

Time frame: Up to 5 months

Incidence of adverse events

Time frame: Up to 5 months

Data from ClinicalTrials.gov

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