Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Bone Density Conservation Agents

Aromatase Inhibitors

Diphosphonates

Ibandronic Acid

Ibandronic acid 150 mg per os per month for two years

Ibandronic acid

Placebo

Lorenzo Livi, Professor

Meattini Icro, M.D.

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.

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 of Oral Bisphosphonate for Osteopenic Women Treated With Adjuvant Aromatase Inhibitors

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

Lumbar spine and trochanter T-score mean difference

Number of Participants with Adverse Events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Oral Bisphosphonate for Osteopenic Women Treated With Adjuvant Aromatase Inhibitors	NCT02616744	Breast Cancer	Ibandronic acid Placebo	18 Years - 75 Years	Azienda Ospedaliero-Universitaria Careggi
Study of Oral Bisphosphonate for Osteopenic Women Treated With Adjuvant Aromatase Inhibitors	NCT02616744	Breast Cancer	Ibandronic acid Placebo	18 Years - 75 Years	Azienda Ospedaliero-Universitaria Careggi

Spots Global Cancer Trial Database for ibandronic acid