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
Recruitment status was Recruiting
Sponsor:
University of Turku
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
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
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| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| ClinicalTrials.gov 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 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by University of Turku:
|
breast cancer skeletal metastases bisphosphonate therapy Breast cancer with painful skeletal metastases |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasm Metastasis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Neoplastic Processes Pathologic Processes Ibandronic acid Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013