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ACTIVE NOT RECRUITING
NCT03324932
PHASE3

Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer

Sponsor: Kyoto Prefectural University of Medicine

View on ClinicalTrials.gov

Summary

This multicenter, randomized, comparative study will evaluate the efficacy of denosumab to prevent the adjuvant therapy of aromatase inhibitors-induced loss of bone mineral density (BMD) in breast cancer patients with normal BMD. Investigators will compare the inhibitory effects of denosumab on bone loss between participants with normal BMD to whom Letrozole or Arimidex will be administered as postoperative endocrine therapy for stage I-IIIA postmenopausal hormone-sensitive breast cancer and controls.

Official title: A Multicenter, Randomized, Comparative Study Regarding the Efficacy of Denosumab on Normal Bone Mineral Density in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer (ENDEAVOR Trial)

Key Details

Gender

FEMALE

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2017-09-25

Completion Date

2027-12

Last Updated

2023-10-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

Denosumab Injection

AI intake + denosumab injection per 6 months VS only AI intake

Locations (1)

Hisako Ono

Kyoto, Japan