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

Study Overview
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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.

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.

Official Title
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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 Adjuvant Aromatase Inhibitors - BONADIUV Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Ibandronic acid
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Ibandronic acid<br>Ibandronic acid 150 mg per os per month for two years | Drug: Ibandronic acid<br>* 150 mg per month oral ibandronate<br>* Other names: Ibandronate;|
| Placebo Comparator: Arm B: Placebo<br>Placebo per os per month for two years | Drug: Placebo<br>* 1 oral capsule of placebo per month<br>* Other names: Placebo capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar spine and trochanter T-score mean difference as measure of BMD variation | Lumbar spine and trochanter T-score mean difference | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Number of Participants with Adverse Events | 2 years | 
| Overall Survival (OS) | Overall Survival (OS) rate | 5 years | 
| Disease-free Survival (DFS) | Disease-free Survival (DFS) rate | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aromatase inhibitors, breast cancer, bone mineral density