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Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by University of Turku.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT00381368
First received: September 25, 2006
Last updated: December 1, 2006
Last verified: November 2006

September 25, 2006
December 1, 2006
October 2006
Not Provided
  • Worst and average pain in movement and rest on the visual analogue scale (VAS) before the first dose, on days 2, 3, 7 and on day 28
  • Analgesic consumption during the same period will additionally be assessed
  • Worst and average pain in movement and rest on the VAS before the first dose, on days 2,3, 7 and on day 28.
  • Analgesic consumption during the same period will additionally be assessed.
Complete list of historical versions of study NCT00381368 on ClinicalTrials.gov Archive Site
  • Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28
  • World Health Organization (WHO) performance status
  • Safety: serum cystatin C and serum creatinine, and reporting of adverse events
  • Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28.
  • WHO performance status
  • Safety: serum cystatin C and serum creatinine, and reporting of adverse events
Not Provided
Not Provided
 
Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients
Phase II Open Label Study to Establish the Safety and Efficacy of Intravenous Loading Dose of Ibandronate 6 mg in 3 Consecutive Days in Breast Cancer Patients With Skeletal Metastases

The purpose of the study is to determine the efficacy and safety of a three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients with painful skeletal metastases.

Painful skeletal metastases are a common site of advanced disease. For instance, in breast cancer, and despite cancer treatments (radiotherapy, cytotoxic treatment and adequate treatment of pain), the patients often need additional treatments that may relieve their symptoms. Bisphosphonates, such as ibandronic acid, have in pilot studies shown a significant decrease in pain scores, both after loading dose and after long-term treatment. In this study the safety and efficacy of an intravenous loading dose of three times 6 mg ibandronate during three consecutive days in breast cancer patients with painful skeletal metastases will be studied.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: Ibandronic acid
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
Not Provided

Inclusion Criteria:

  • Breast cancer with presence of bone metastases
  • Pain score over 4 on the VAS

Exclusion Criteria:

  • Patients with pathological fractures or medulla compression or neuropathic pain
  • Patients with infection or corticosteroid treatment
  • Pregnant or lactating patients
Both
Not Provided
No
Contact: Outi Paija, MD, PhD +358-2-3130000 ext 52863 outi.paija@tyks.fi
Contact: Tiina Saarto, MD, PhD tiina.saarto@hus.fi
Finland
 
NCT00381368
ML20115, EudraCT: 2006-000697-74
Not Provided
Not Provided
University of Turku
Hoffmann-La Roche
Principal Investigator: Outi Paija, MD, PhD Dept of Oncology, Turku University Hospital, Finland
University of Turku
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP