NCT02616744

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Jan 2011

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

5.3 years

First QC Date

November 24, 2015

Last Update Submit

October 18, 2019

Conditions

Breast Cancer

Keywords

aromatase inhibitorsbreast cancerbone mineral density

Outcome Measures

Primary Outcomes (1)

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

    Lumbar spine and trochanter T-score mean difference

    2 years

Secondary Outcomes (3)

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

    2 years

  • Overall Survival (OS)

    5 years

  • Disease-free Survival (DFS)

    5 years

Study Arms (2)

Arm A: Ibandronic acid

EXPERIMENTAL

Ibandronic acid 150 mg per os per month for two years

Drug: Ibandronic acid

Arm B: Placebo

PLACEBO COMPARATOR

Placebo per os per month for two years

Drug: Placebo

Interventions

Ibandronic acidDRUG

150 mg per month oral ibandronate

Also known as: Ibandronate
Arm A: Ibandronic acid
PlaceboDRUG

1 oral capsule of placebo per month

Also known as: Placebo capsule
Arm B: Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiation Oncology Unit, Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

Location

Related Publications (2)

  • 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.

    PMID: 38979716DERIVED

  • 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.

    PMID: 30648627DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Lorenzo Livi, Professor

    AOU Careggi - University of Florence, Florence, Italy

    PRINCIPAL INVESTIGATOR

  • Meattini Icro, M.D.

    AOU Careggi - University of Florence, Florence, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

November 24, 2015

First Posted

November 30, 2015

Study Start

January 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)