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

This study has been completed.

First Received: July 17, 2007 Last Updated: September 16, 2009 History of Changes

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

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Bone Cancer Bone Diseases Breast Cancer Cancer

Drug Information available for: Ibandronic acid Ibandronate sodium

U.S. FDA Resources

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 ]

Enrollment:	13
Study Completion Date:	March 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

Locations

Turkey

ISTANBUL, Turkey, 34300

IZMIR, Turkey, 35100

ANKARA, Turkey, 06100

ANKARA, Turkey, 06018

ISTANBUL, Turkey, 34390

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20684
Study First Received:	July 17, 2007
Last Updated:	September 16, 2009
ClinicalTrials.gov Identifier:	NCT00502736 History of Changes
Health Authority:	Turkey: Ministry of Health

Additional relevant MeSH terms:

Bone Neoplasms
Skin Diseases
Physiological Effects of Drugs
Breast Neoplasms
Bone Density Conservation Agents
Bone Diseases
Pharmacologic Actions
Neoplasms

Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Musculoskeletal Diseases
Ibandronic acid
Neoplasm Metastasis
Breast Diseases

ClinicalTrials.gov processed this record on November 25, 2009