Breast CancerPhase 2NCT00381368
Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients
A Phase 2 study testing Ibandronic acid in people with Breast Cancer, run by University of Turku at 3 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ibandronic acid
- How many people
- 60 participants
- Where
- 3 sitesFinland
- Study dates
- Oct 2006to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Breast cancer with presence of bone metastases
- Pain score over 4 on the VAS
Who cannot join
- Patients with pathological fractures or medulla compression or neuropathic pain
- Patients with infection or corticosteroid treatment
- Pregnant or lactating patients
Trial locations and contacts
3 sites in 1 country.
Tiina Saarto, MD, PhD contact
Finland3 sites, 3 recruiting
- Not yet recruiting
Dept of Oncology, Helsinki University Central Hospital
Helsinki, Helsinki, 00029
Tiina Saarto, MD, PhD
- Recruiting
Dept of Oncology, Oulu University Hospital
Oulu, Oulu, 90029
Arja Jukkola, MD, PhD
- Not yet recruiting
Dept of Oncology, Tampere University Hospital
Tampere, 33521
Pirkko Kellokumpu-Lehtinen, PhD, professor
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Ibandronic acid
- Keywords
- breast cancer, skeletal metastases, bisphosphonate therapy, Breast cancer with painful skeletal metastases
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibandronic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Outi Paija, MD, PhD, Principal investigator, Dept of Oncology, Turku University Hospital, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381368
- Sponsor's protocol ID
- ML20115
- Other IDs
- EudraCT: 2006-000697-74
- Status last verified
- Nov 2006
- First submitted
- 25 Sep 2006
- Last updated
- 4 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00381368
- Acronym / sponsor ID
- ML20115
- Conditions
- Breast Cancer
- Keywords
- breast cancer, skeletal metastases, bisphosphonate therapy, Breast cancer with painful skeletal metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Oct 2006
- First posted
- 27 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Breast cancer with presence of bone metastases
- Pain score over 4 on the VAS
Key exclusion criteria (3 listed)
- Patients with pathological fractures or medulla compression or neuropathic pain
- Patients with infection or corticosteroid treatment
- Pregnant or lactating patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibandronic acid | Drug | – |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiina Saarto, MD, PhD contact
Outi Paija, MD, PhD principal investigator
Dept of Oncology, Turku University Hospital, Finland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibandronic acid in people with Breast Cancer, run by University of Turku at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Outi Paija, MD, PhD (+358-2-3130000 ext. 52863, outi.paija@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2006.