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

Roche

Status and phase: Completed; Phase 4

Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis

Treatments: Drug: Ibandronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02564107

ML18044

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Ibandronate

Experimental group

Description:

Female participants with metastatic bone disease secondary to breast cancer will receive ibandronate for a period of 25 weeks.

Treatment:

Drug: Ibandronate