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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 (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00502736
First received: July 17, 2007
Last updated: January 20, 2014
Last verified: January 2014
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pain and analgesic consumption [ Time Frame: Days 1, 7 and 14 ]

Secondary Outcome Measures:
  • AEs and laboratory parameters [ Time Frame: Days 1, 4 and 7 ]
  • Serum creatinine [ Time Frame: Days 1, 4 and 7 ]
  • Karnofsky index [ Time Frame: Day 7 ]

Enrollment: 13
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bondronat]
6mg iv on days 1-3

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Turkey
Ankara, Turkey, 06018
Ankara, Turkey, 06230
Istanbul, Turkey, 34300
Istanbul, Turkey, 34390
Izmir, Turkey, 35100
Shhiye, Ankara, Turkey, 06100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00502736     History of Changes
Other Study ID Numbers: ML20684
Study First Received: July 17, 2007
Last Updated: January 20, 2014

Additional relevant MeSH terms:
Neoplasm Metastasis
Bone Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Ibandronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017