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

Breast Cancer Clinical Trial

— BONADIUV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616744
• Other study ID #: BONADIUV
• Status: Completed
• Phase: Phase 2
• Start date: January 2011
• Est. completion date: May 2016

Study information

• Verified date: October 2019
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Ibandronic acid
150 mg per month oral ibandronate
• Placebo
1 oral capsule of placebo per month

Locations

Country	Name	City	State
Italy	Radiation Oncology Unit, Azienda Ospedaliero-Universitaria Careggi	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar spine and trochanter T-score mean difference as measure of BMD variation	Lumbar spine and trochanter T-score mean difference	2 years
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Number of Participants with Adverse Events	2 years
Secondary	Overall Survival (OS)	Overall Survival (OS) rate	5 years
Secondary	Disease-free Survival (DFS)	Disease-free Survival (DFS) rate	5 years

External Links

•   Eur J Cancer. 2019 Feb;108:100-110. doi: 10.1016/j.ejca.2018.12.005. Epub 2019 Jan 14.