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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00502736
First received: July 17, 2007
Last updated: September 16, 2009
Last verified: September 2009
History of Changes
  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 2

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 Bone Pain in Patients With Breast Cancer and Skeletal Metastases

Resource links provided by NLM:

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
Experimental: 1 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
Ankara, Turkey, 06100
Ankara, Turkey, 06018
Istanbul, Turkey, 34300
Istanbul, Turkey, 34390
Izmir, Turkey, 35100
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: NCT00502736     History of Changes
Other Study ID Numbers: ML20684
Study First Received: July 17, 2007
Last Updated: September 16, 2009
Health Authority: Turkey: Ministry of Health

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 May 16, 2013