A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.

Phase 2

Completed

• Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis
• Interventions: Drug: ibandronate [Bondronat]

• Registration Number: NCT00502736
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is 3 months, and the target sample size is \<100 individuals.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-18
• Study Start: 2008-01
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

• female patients, >=18 years of age;
• breast cancer;
• bone metastases;
• moderate to severe pain;
• adequate renal function.

Exclusion Criteria

• bisphosphonate treatment within 3 weeks of study enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ibandronate [Bondronat]	-

Primary Outcome Measures

Name	Time	Method
Pain and analgesic consumption	Days 1, 7 and 14

Secondary Outcome Measures

Name	Time	Method
AEs and laboratory parameters	Days 1, 4 and 7
Serum creatinine	Days 1, 4 and 7
Karnofsky index	Day 7