This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
Hoffmann-La Roche
Information provided by:
University of Turku Identifier:
First received: September 25, 2006
Last updated: December 1, 2006
Last verified: November 2006
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.

Ages Eligible for Study:   Child, Adult, Senior
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
  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 identifier: NCT00381368

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

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
Principal Investigator: Outi Paija, MD, PhD Dept of Oncology, Turku University Hospital, Finland
  More Information Identifier: NCT00381368     History of Changes
Other Study ID Numbers: ML20115
EudraCT: 2006-000697-74
Study First Received: September 25, 2006
Last Updated: December 1, 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
Breast Diseases
Skin Diseases
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on September 19, 2017