ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.

This study is currently recruiting participants.
Verified by Hoffmann-La Roche, August 2008

Sponsored by: 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

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




Links to all studies - primarily for crawlers