Clinical study on improving osteoporosis after endocrine therapy of breast cancer with Combination of Chinese and Western medicine

Phase 2

• Conditions: breast cancer

• Registration Number: ITMCTR2000003576
• Lead Sponsor: Shanghai First Maternal and Infant Health Care Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1) All patients in this study were female and had no history of osteoporosis or other diseases affecting bone metabolism before endocrine treatment;
2) according to the age of >60 years after bilateral ovariectomy, or age =60 years but with menopause of more than 12 months and estrogen progesterone level within the postmenopausal range, all patients were in postmenopausal status;
3) All patients were histopathologically diagnosed with breast cancer, and the hormone receptors were ER (+) and (or) PR (+).
4) The patient has received modified radical mastectomy, simple resection or breast conserving surgery;
5) The patient has been treated with AI (Letrozole or anastrozole or exemestane) endocrine adjuvant therapy for more than 1 year, and has been diagnosed as bone mass loss or osteoporosis according to the diagnostic criteria of osteoporosis by the World Health Organization;
6) Chest radiographs, B-ultrasound, bone ECT and contralateral mammography confirmed that no obvious distant metastasis was found in the whole body of all the patients, and no abnormalities were found in the three routine, electrocardiogram and liver and kidney functions.

Exclusion Criteria

1) Liver and kidney function was significantly abnormal (serum ALT/AST was 1 times or more than the normal upper limit, serum Cr=150 mol/L;
2) Suffering from other major organ diseases, including severe heart disease;
3) Other primary malignant tumors;
4) Pre-menopausal breast cancer patients;
5) Those who meet the inclusion criteria, fail to complete the treatment as prescribed, fail to judge the curative effect or have incomplete data affecting the judgment of curative effect.

Study & Design

• Study Type: Prevention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hepatorenal function;BMD;