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

Hoffmann-La Roche48 enrolled

Overview

This study will evaluate the efficacy, safety, and effect on quality of life of oral ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The anticipated time on study treatment is 25 weeks, and the target sample size is 50 individuals.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain; Bone Neoplasms; Neoplasm Metastasis

Interventions

IbandronateDRUG

Participants will receive ibandronate, 50 milligrams (mg) by mouth every morning, for a period of 25 weeks.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Females at least 18 years of age * Breast cancer * Bone metastases Exclusion Criteria: * Use of bisphosphonates within the last 3 months * Prior use of gallium nitrate or metastron * Severely impaired renal function * Hypocalcemia or primary hyperparathyroidism * Central nervous system (CNS) metastases

Locations (8)

Unnamed facility

Plovdiv, Bulgaria

Unnamed facility

Shumen, Bulgaria

Unnamed facility

Sofia, Bulgaria

Unnamed facility

Sofia, Bulgaria

Outcomes

Primary Outcomes

Cumulative incidence of skeletal events according to Skeletal Morbidity Period Rate (SMPR)

Time frame: Up to 25 weeks

Secondary Outcomes

Incidence of bone pain according to participant questionnaire

Time frame: Up to 25 weeks

Analgesic consumption according to participant questionnaire

Time frame: Up to 25 weeks

Change in serum pyridinoline cross-linked carboxyterminal telopeptide of collagen type I (ICTP)

Time frame: Up to 25 weeks

Short Form 36 (SF-36) score

Time frame: Up to 25 weeks

Incidence of adverse events (AEs)

Time frame: Up to approximately 7 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.