AzTrials
AzTrials

Pain; Bone Neoplasms; Neoplasm MetastasisPhase 3NCT02716792

A Study to Evaluate Renal Safety of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Disease Due to Breast Cancer

A Phase 3 study testing Ibandronate in people with Pain; Bone Neoplasms; Neoplasm Metastasis, run by Hoffmann-La Roche at 30 sites in France.

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 evaluate renal function in participants with metastatic bone disease due to breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams (mg), over either 15 minutes or 60 minutes, every 3 weeks. 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
334 participants
Where
30 sitesFrance
Study dates
Jan 2006to Aug 2008
Phase
Phase 3
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

  • For participants of childbearing potential: negative pregnancy test and ready to use effective contraceptive measures
  • Metastatic breast cancer with at least one bone metastasis
  • Karnofsky index >/= 60
  • Life expectancy >/= 6 months
  • Estimated creatinine clearance (Cockcroft and Gault formula) >/= 30 milliliters per minute (mL/min)

Who cannot join

  • Pregnancy or breast feeding participant
  • Participant who had a current dental problem, particularly tooth or jaw infection, trauma or surgery on tooth or jaw in the previous six weeks, medical history of jaw osteonecrosis or delayed healing after dental surgery
  • Participant who was participating or had participated in the last 30 days to a clinical trial investigating treatments
  • Uncontrolled brain metastasis
  • Severe or concomitant infection
  • Known medical history of systemic disease with renal lesion
Show all 13Show fewer
  • Rapidly progressing renal failure at inclusion
  • Uncontrolled cardiac disorder
  • Hypercalcaemia (> 2.7 millimoles per liter [mmol/L]), hypocalcaemia (< 2 mmol/L)
  • Participant receiving nephrotoxic chemotherapy
  • Participant eligible for haematopoietic stem cell transplantation at inclusion time
  • Bisphosphonate therapy in the 3 weeks before randomization
  • Known hypersensitivity to ibandronate or other bisphosphonates

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

France30 sites

  • Study site

    Amboise, 37403

  • Study site

    Angers, 49933

  • Study site

    Bayonne, 64100

  • Study site

    Besançon, 25030

  • Study site

    Boulogne-Billancourt, 92100

  • Study site

    Brest, 29609

  • Study site

    Chambéry, 73011

  • Study site

    Clermont-Ferrand, 63011

  • Study site

    Évreux, 27000

  • Study site

    Gap, 05007

  • Study site

    Hyères, 83400

  • Study site

    Le Chesnay, 78157

  • Study site

    Metz-Tessy, 74370

  • Study site

    Nantes, 44202

  • Study site

    Neuilly-sur-Seine, 92200

  • Study site

    Paris, 75475

  • Study site

    Paris, 75674

  • Study site

    Paris, 75970

  • Study site

    Rennes, 35042

  • Study site

    Rouen, 76000

  • Study site

    Saint-Brieuc, 22015

  • Study site

    Saint-Cloud, 92210

  • Study site

    Saint-Grégoire, 35768

  • Study site

    Saint-Jean, 31240

  • Study site

    Salouël, 80480

  • Study site

    Strasbourg, 67010

  • Study site

    Trappes, 78190

  • Study site

    Valenciennes, 59322

  • Study site

    Vandœuvre-lès-Nancy, 54511

  • Study site

    Villejuif, 94804

Other trials in France

About this study

Official title: Randomized, Open Label Study to Evaluate Renal Safety of Intravenous Bondronat 6 mg Infusions Over 15 Minutes Versus 60 Minutes in Patients With Metastatic Bone Disease Due to Breast Cancer

This study will evaluate renal function in participants with metastatic bone disease due to breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams (mg), over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of ibandronate in the 2 groups of participants will also be compared. The anticipated time on study treatment is 7 months, and the target sample size is 318 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 via IV infusion, every 3 weeks for up to 9 cycles. The infusion interval will be either 15 or 60 minutes depending upon treatment group assignment every 3 weeks (9 treatment cycles in total).

Study groups in NCT02716792
Study groupRoleWhat they receive
Ibandronate 15-Minute InfusionExperimentalParticipants will receive ibandronate IV infusions over a 15-minute interval.
Receives: Drug: Ibandronate
Ibandronate 60-Minute InfusionActive comparatorParticipants will receive ibandronate IV infusions over a 60-minute interval.
Receives: Drug: Ibandronate

What is being measured

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

  1. Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula

    Measured: 28 days after last infusion (approximately 2 years)

Secondary outcomes (4)

  1. Number of Participants with Bone Pain According to Visual Analog Scale (VAS)

    Measured: Every 3 weeks up to approximately 6 months

  2. Number of Participants With of Skeletal Events (Vertebral and Non-Vertebral Fractures, Impending Fracture, Radiotherapy or Surgery to Bone)

    Measured: Up to approximately 7 months

  3. Percentage of Participants on Analgesics According to World Health Organization (WHO) Three-Step Analgesic Ladder

    Measured: Up to approximately 7 months

  4. Karnofsky Index score

    Measured: Every 3 weeks up to approximately 6 months

Timeline

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

  1. First posted23 Mar 2016 (estimated)
  2. Study startJan 2006
  3. Primary completionJun 2008
  4. Study completionAug 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02716792
Sponsor's protocol ID
ML19188
Status last verified
Mar 2016
First submitted
18 Mar 2016
Last updated
23 Mar 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibandronate in people with Pain; Bone Neoplasms; Neoplasm Metastasis, run by Hoffmann-La Roche at 30 sites in France.

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 5 inclusion and 13 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 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula (time frame: 28 days after last infusion (approximately 2 years)). 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 NCT02716792.

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 23 Mar 2016.

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