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

Tracking Information

First Received Date ^ICMJE

July 17, 2007

Last Updated Date

September 16, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Pain and analgesic consumption [ Time Frame: Days 1, 7 and 14 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Pain and analgesic consumption on days 1, 7 and 14.

Change History

Complete list of historical versions of study NCT00502736 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

AEs and laboratory parameters [ Time Frame: Days 1, 4 and 7 ] [ Designated as safety issue: No ]
Serum creatinine [ Time Frame: Days 1, 4 and 7 ] [ Designated as safety issue: No ]
Karnofsky index [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety: AEs, serum creatinine, laboratory parameters.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pain; Bone Neoplasms; Neoplasm Metastasis

Intervention ^ICMJE

Drug: ibandronate [Bondronat]

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT ID ^ICMJE

NCT00502736

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Study ID Numbers ^ICMJE

ML20684

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP