AzTrials
AzTrials

Pain; Bone Neoplasms; Neoplasm MetastasisPhase 4NCT02553707

A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer

A Phase 4 study testing Ibandronate in people with Pain; Bone Neoplasms; Neoplasm Metastasis, run by Hoffmann-La Roche at 15 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will assess the short term efficacy of ibandronate (6 mg intravenous [IV]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Ibandronate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
15 sitesHungary
Study dates
Jul 2006to Dec 2008
Phase
Phase 4
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female participants greater than or equal to (>=) 18 years of age
  • Breast cancer with bone metastases
  • Pain score of >=4 on Worst Pain scale of Brief Pain Inventory (BPI)
  • Stable analgesic regimen.

Who cannot join

  • Participants who have received a bisphosphonate within 3 weeks of start of trial
  • Radiotherapy to bone within 4 weeks of enrolment
  • Hypersensitivity to ibandronate
  • Central nervous system (CNS) or meningeal metastases

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Hungary15 sites

  • Study site

    Budapest, 1031

  • Study site

    Budapest, 1082

  • Study site

    Budapest, 1106

  • Study site

    Budapest, 1122

  • Study site

    Budapest, 1135

  • Study site

    Budapest, 1145

  • Study site

    Győr, 9002

  • Study site

    Gyula, 5700

  • Study site

    Kecskemét, 6000

  • Study site

    Nyíregyháza, 4400

  • Study site

    Szeged, 6720

  • Study site

    Székesfehérvár, 8000

  • Study site

    Szombathely, 9700

  • Study site

    Veszprém, 8200

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

About this study

Official title: Open-Label Study to Establish the Short Term Efficacy of Intravenous Loading-Doses of Bondronat 6 mg in Patients With Breast Cancer and Skeletal Metastases Experiencing Moderate to Severe Pain, Within 7 Days After Initiation of Treatment

This study will assess the short term efficacy of ibandronate (6 mg intravenous [IV]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and the target sample size is 182 individuals.

Being tested
Ibandronate
Medical subject headings
Pain, Bone Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbandronateDrug

    Also called Bondronat

    Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.

Study groups in NCT02553707
Study groupRoleWhat they receive
IbandronateExperimentalParticipants will receive ibandronate 6 mg IV on Days 1, 2, and 3.
Receives: Drug: Ibandronate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with >=25% reduction in mean pain

    Measured: up to Day 6

  2. Percentage of participants with =<35% increase in mean analgesic consumption

    Measured: up to Days 7

Secondary outcomes (4)

  1. Change from Baseline in average pain score

    Measured: Baseline (Days 0), 5, and 7

  2. Analgesic consumption

    Measured: up to Day 7

  3. Pain response

    Measured: up to Day 7

  4. Time to pain response

    Measured: up to Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2015 (estimated)
  2. Study startJul 2006
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02553707
Sponsor's protocol ID
ML20268
Status last verified
Sep 2015
First submitted
16 Sep 2015
Last updated
17 Sep 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ibandronate in people with Pain; Bone Neoplasms; Neoplasm Metastasis, run by Hoffmann-La Roche at 15 sites in Hungary.

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Hungary. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with >=25% reduction in mean pain (time frame: up to Day 6). 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?

On the ClinicalTrials.gov record for NCT02553707.

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 17 Sep 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in