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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00478270

Purpose

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.

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

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

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 response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption [ Time Frame: Days 5 - 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean worst pain score over first 7 days [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Analgesic consumption [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Karnofsky index [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	52
Estimated Study Completion Date:	January 2008

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

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478270

Locations

Greece

Alexandroupolis, Greece

Athens, Greece

Haidari, Greece

Patras, Greece

Piraeus, Greece

Thessaloniki, Greece

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00478270 History of Changes
Other Study ID Numbers:	ML20247
Study First Received:	May 23, 2007
Last Updated:	March 19, 2008
Health Authority:	Greece: E.O.F. (National drug organization)

Additional relevant MeSH terms:

Bone Neoplasms
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Breast Diseases

Skin Diseases
Neoplastic Processes
Pathologic Processes
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012