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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm A: Ibandronic acid

Ibandronic acid 150 mg per os per month for two years

Group Type EXPERIMENTAL

Ibandronic acid

Intervention Type DRUG

150 mg per month oral ibandronate

Arm B: Placebo

Placebo per os per month for two years

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 oral capsule of placebo per month

Interventions

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Ibandronic acid

150 mg per month oral ibandronate

Intervention Type DRUG

Placebo

1 oral capsule of placebo per month

Intervention Type DRUG

Other Intervention Names

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Ibandronate Placebo capsule

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No