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

Pain; Bone Neoplasms; Neoplasm Metastasis Clinical Trial

Official title:

An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Bone Pain in Patients With Breast Cancer and Skeletal Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502736
• Other study ID #: ML20684
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2007
• Last updated: January 20, 2014
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: January 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Neoplasms
• Neoplasm Metastasis
• Pain; Bone Neoplasms; Neoplasm Metastasis

Intervention

Drug:
• ibandronate [Bondronat]
6mg iv on days 1-3

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and analgesic consumption		Days 1, 7 and 14	No
Secondary	AEs and laboratory parameters		Days 1, 4 and 7	No
Secondary	Serum creatinine		Days 1, 4 and 7	No
Secondary	Karnofsky index		Day 7	No