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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. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by University of Turku.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00381368
First Posted: September 27, 2006
Last Update Posted: December 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Turku
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: Ibandronic acid Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Turku:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: October 2006
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381368


Contacts
Contact: Outi Paija, MD, PhD +358-2-3130000 ext 52863 outi.paija@tyks.fi
Contact: Tiina Saarto, MD, PhD tiina.saarto@hus.fi

Locations
Finland
Dept of Oncology, Helsinki University Central Hospital Not yet recruiting
Helsinki, Finland, 00029
Principal Investigator: Tiina Saarto, MD, PhD         
Dept of Oncology, Oulu University Hospital Recruiting
Oulu, Finland, 90029
Principal Investigator: Arja Jukkola, MD, PhD         
Dept of Oncology, Tampere University Hospital Not yet recruiting
Tampere, Finland, 33521
Principal Investigator: Pirkko Kellokumpu-Lehtinen, PhD, professor         
Sponsors and Collaborators
University of Turku
Hoffmann-La Roche
Investigators
Principal Investigator: Outi Paija, MD, PhD Dept of Oncology, Turku University Hospital, Finland
  More Information

ClinicalTrials.gov Identifier: NCT00381368     History of Changes
Other Study ID Numbers: ML20115
EudraCT: 2006-000697-74
First Submitted: September 25, 2006
First Posted: September 27, 2006
Last Update Posted: December 4, 2006
Last Verified: November 2006

Keywords provided by University of Turku:
breast cancer
skeletal metastases
bisphosphonate therapy
Breast cancer with painful skeletal metastases

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs