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

Purpose

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.

Condition	Intervention	Phase
Pain; Bone Neoplasms; Neoplasm Metastasis	Drug: ibandronate [Bondronat]	Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Bone Cancer Bone Diseases Breast Cancer Cancer

ChemIDplus related topics:

Ibandronate sodium Ibandronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	24
Study Start Date:	October 2007
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
1: Experimental	Drug: ibandronate [Bondronat] 6mg iv on days 1-3

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502736

Contacts


Contact: Please reference Study ID Number: RLI_ML20684	973-235-5000

Contact: or	800-526-6367 (FOR US ONLY)

Locations


Turkey
		Recruiting
	ISTANBUL, Turkey, 34300
		Recruiting
	IZMIR, Turkey, 35100
		Recruiting
	ANKARA, Turkey, 06100
		Recruiting
	ANKARA, Turkey, 06018
		Recruiting
	ISTANBUL, Turkey, 34390

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20684
First Received:	July 17, 2007
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00502736
Health Authority:	Turkey: Ministry of Health

Study placed in the following topic categories:

Ibandronic acid

Skin Diseases

Musculoskeletal Diseases

Bone Neoplasms

Bone neoplasms

Neoplasm Metastasis

Breast Neoplasms

Pain

Bone Diseases

Breast Diseases

Additional relevant MeSH terms:

Neoplastic Processes

Neoplasms

Pathologic Processes

Neoplasms by Site

Physiological Effects of Drugs

Bone Density Conservation Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00502736