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

Sponsor

Azienda Ospedaliero-Universitaria Careggi (Other)

Overall Status

Completed

CT.gov ID

NCT02616744

Collaborator

(none)

171

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Ibandronic acid Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

171 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: Ibandronic acid Ibandronic acid 150 mg per os per month for two years	Drug: Ibandronic acid 150 mg per month oral ibandronate Other Names: Ibandronate
Placebo Comparator: Arm B: Placebo Placebo per os per month for two years	Drug: Placebo 1 oral capsule of placebo per month Other Names: Placebo capsule

Arm

Intervention/Treatment

Experimental: Arm A: Ibandronic acid

Ibandronic acid 150 mg per os per month for two years

Drug: Ibandronic acid

150 mg per month oral ibandronate

Other Names:

Ibandronate

Placebo Comparator: Arm B: Placebo

Placebo per os per month for two years

Drug: Placebo

1 oral capsule of placebo per month

Other Names:

Placebo capsule

Outcome Measures

Primary Outcome Measures

Lumbar spine and trochanter T-score mean difference as measure of BMD variation [2 years]
Lumbar spine and trochanter T-score mean difference

Secondary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [2 years]
Number of Participants with Adverse Events
Overall Survival (OS) [5 years]
Overall Survival (OS) rate
Disease-free Survival (DFS) [5 years]
Disease-free Survival (DFS) rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiation Oncology Unit, Azienda Ospedaliero-Universitaria Careggi	Florence		Italy	50134

Sponsors and Collaborators

Azienda Ospedaliero-Universitaria Careggi

Investigators

Principal Investigator: Lorenzo Livi, Professor, AOU Careggi - University of Florence, Florence, Italy
Principal Investigator: Meattini Icro, M.D., AOU Careggi - University of Florence, Florence, Italy