CompletedPhase 2

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

Italy171 participantsStarted 2011-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Lumbar spine and trochanter T-score mean difference as measure of BMD variation

Timeframe: 2 years

Trial details

NCT IDNCT02616744

SponsorAzienda Ospedaliero-Universitaria Careggi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05

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