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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi
• Treatments: Aromatase Inhibitors; Diphosphonates; Ibandronic Acid

Criteria

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