Back to resultsSafety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Ibandronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, skeletal metastases, bisphosphonate therapy, Breast cancer with painful skeletal metastases
Eligibility 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
Sites / Locations
- Dept of Oncology, Helsinki University Central Hospital
- Dept of Oncology, Oulu University HospitalRecruiting
- Dept of Oncology, Tampere University Hospital
Outcomes
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
Full Information
NCT ID
NCT00381368
First Posted
September 25, 2006
Last Updated
December 1, 2006
Sponsor
University of Turku
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00381368
Brief Title
Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients
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 Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Turku
Collaborators
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, skeletal metastases, bisphosphonate therapy, Breast cancer with painful skeletal metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ibandronic acid
Primary Outcome Measure Information:
Title
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
Title
Analgesic consumption during the same period will additionally be assessed
Secondary Outcome Measure Information:
Title
Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28
Title
World Health Organization (WHO) performance status
Title
Safety: serum cystatin C and serum creatinine, and reporting of adverse events
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Outi Paija, MD, PhD
Phone
+358-2-3130000
Ext
52863
Email
outi.paija@tyks.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Tiina Saarto, MD, PhD
Email
tiina.saarto@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Outi Paija, MD, PhD
Organizational Affiliation
Dept of Oncology, Turku University Hospital, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Oncology, Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiina Saarto, MD, PhD
Facility Name
Dept of Oncology, Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arja Jukkola, MD, PhD
Facility Name
Dept of Oncology, Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pirkko Kellokumpu-Lehtinen, PhD, professor
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients
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