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

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. Identifier: NCT00381368
Recruitment Status : Unknown
Verified November 2006 by University of Turku.
Recruitment status was:  Recruiting
First Posted : September 27, 2006
Last Update Posted : December 4, 2006
Hoffmann-La Roche
Information provided by:
University of Turku

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Ibandronic acid Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
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
Study Start Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. 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
  2. Analgesic consumption during the same period will additionally be assessed

Secondary Outcome Measures :
  1. Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28
  2. World Health Organization (WHO) performance status
  3. Safety: serum cystatin C and serum creatinine, and reporting of adverse events

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00381368

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Contact: Outi Paija, MD, PhD +358-2-3130000 ext 52863
Contact: Tiina Saarto, MD, PhD

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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
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Principal Investigator: Outi Paija, MD, PhD Dept of Oncology, Turku University Hospital, Finland
Layout table for additonal information Identifier: NCT00381368    
Other Study ID Numbers: ML20115
EudraCT: 2006-000697-74
First Posted: September 27, 2006    Key Record Dates
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:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs