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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00478270
• Other study ID #: ML20247
• Status: Withdrawn
• Phase: Phase 2
• First received: May 23, 2007
• Last updated: August 14, 2017
• Start date: June 2007
• Est. completion date: February 2008

Study information

• Verified date: August 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic 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• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• breast cancer;

• bone metastases;

• mean worst pain score >=4 during 3 day baseline period;

• stable dose of analgesics over a 3 day baseline period;

• adequate renal function.

Exclusion Criteria:

• bisphosphonate treatment within 3 weeks of study enrollment;

• a change in antineoplastic treatment within 6 weeks of study enrollment;

• bone radiation within 2 weeks of study enrollment;

• active infection.

Related Conditions & MeSH terms

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

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

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption		Days 5 - 7
Secondary	Mean worst pain score over first 7 days		Day 7
Secondary	Analgesic consumption		Day 7
Secondary	Karnofsky index		Day 7
Secondary	AEs, laboratory parameters		Throughout study