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Breast CancerPhase 2BONADIUVNCT02616744

Study of Oral Bisphosphonate for Osteopenic Women Treated With Adjuvant Aromatase Inhibitors

A Phase 2 study testing Ibandronic acid in people with Breast Cancer, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.

Completed

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

Official record
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Trial summary

A single--blind, randomized, placebo--controlled phase II study to evaluate the impact of oral bisphosphonate treatment on bone mineral density in osteopenic women receiving aromatase inhibitors as adjuvant treatment. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Ibandronic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
171 participants
Where
1 siteItaly
Study dates
Jan 2011to May 2016
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 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of hormone-receptor positive early breast cancer
  • Menopausal status
  • Age < 75 years
  • Written informed consent

Who cannot join

  • Premenopausal status at time of randomization
  • Comorbidities with increased risk of osteoporosis (primary hyperparathyroidism, hyperthyroidism, rheumatoid arthritis)
  • BMI < 18
  • Chronic use of steroids
  • Use of bisphosphonates at time of randomization
  • Psychiatric disorders

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Radiation Oncology Unit, Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

Other trials in Italy

About this study

Official title: A Single--blind, Randomized, Placebo--controlled Phase II Study to Evaluate the Impact of Oral Bisphosphonate Treatment on Bone Mineral Density in Osteopenic Women Receiving Adjuvant Aromatase Inhibitors - BONADIUV Trial

A single--blind, randomized, placebo--controlled phase II study to evaluate the impact of oral bisphosphonate treatment on bone mineral density in osteopenic women receiving aromatase inhibitors as adjuvant treatment.

Read the detailed description

Aromatase inhibitors (AIs) are the adjuvant treatment of choice in postmenopausal women with early, hormone receptor-positive breast cancer (BC), because they produce improved survival rates compared with tamoxifen. Progressive bone loss and subsequent fractures are associated with adjuvant AIs, administered either alone or sequentially after tamoxifen in postmenopausal women with early BC. Recent findings of National Surgical Adjuvant Breast and Bowel Project (NSABP) B-34 also suggest that bisphosphonates might have anticancer benefits for older postmenopausal women. "BONADIUV" trial is a single-blind, randomized, placebo-controlled study designed to evaluate the impact of bisphosphonate treatment on bone mineral density (BMD) in women taking AIs.

Patients undergo a baseline BMD and if they result osteopenic (lumbar spine and/or trochanter -1< T-score <2.5), they are randomized in a 1:1 ratio to receive either placebo or oral ibandronate. All patients receive oral supplementation of calcium and Vitamin D3, once daily for two years. Study duration is 2 year, with planned six-months evaluation.

A total of 72 patients per arm of treatment are needed to obtain a 85% statistical power in order to detect a 2% BMD mean difference between the two arms. Considering a 15% dropout, around 82 patients per arm are planned to be enrolled.

Conditions
Breast Cancer
Being tested
Ibandronic acid, Placebo
Keywords
aromatase inhibitors, breast cancer, bone mineral density
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

    Also called Ibandronate

    150 mg per month oral ibandronate

  • PlaceboDrug

    Also called Placebo capsule

    1 oral capsule of placebo per month

Study groups in NCT02616744
Study groupRoleWhat they receive
Arm A: Ibandronic acidExperimentalIbandronic acid 150 mg per os per month for two years
Receives: Drug: Ibandronic acid
Arm B: PlaceboPlacebo comparatorPlacebo per os per month for two years
Receives: Drug: Placebo

What is being measured

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

  1. Lumbar spine and trochanter T-score mean difference as measure of BMD variation

    Lumbar spine and trochanter T-score mean difference

    Measured: 2 years

Secondary outcomes (3)

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Number of Participants with Adverse Events

    Measured: 2 years

  2. Overall Survival (OS)

    Overall Survival (OS) rate

    Measured: 5 years

  3. Disease-free Survival (DFS)

    Disease-free Survival (DFS) rate

    Measured: 5 years

Timeline

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

  1. First posted30 Nov 2015 (estimated)
  2. Study startJan 2011
  3. Primary completionMay 2016
  4. Study completionMay 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02616744
Sponsor's protocol ID
BONADIUV
Acronym
BONADIUV
Status last verified
Oct 2019
First submitted
24 Nov 2015
Last updated
22 Oct 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

    PubMed 38979716

  • Livi L, Scotti V, Desideri I, Saieva C, Cecchini S, Francolini G, Becherini C, Delli Paoli C, Visani L, Salvestrini V, De Feo ML, Nori J, Bernini M, Sanchez L, Orzalesi L, Bianchi S, Meattini I. Phase 2 placebo-controlled, single-blind trial to evaluate the impact of oral ibandronate on bone mineral density in osteopenic breast cancer patients receiving adjuvant aromatase inhibitors: 5-year results of the single-centre BONADIUV trial. Eur J Cancer. 2019 Feb;108:100-110. doi: 10.1016/j.ejca.2018.12.005. Epub 2019 Jan 14.

    PubMed 30648627

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibandronic acid in people with Breast Cancer, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.

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 6 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 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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. Some participants in this study may receive a placebo. 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?

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?

Lumbar spine and trochanter T-score mean difference as measure of BMD variation (time frame: 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 NCT02616744, which also lists 2 linked publications.

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 22 Oct 2019.

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