ITMCTR2000003576
Not yet recruiting
Phase 2
Clinical study on improving osteoporosis after endocrine therapy of breast cancer with Combination of Chinese and Western medicine
Shanghai First Maternal and Infant Health Care Hospital0 sitesTBD
Conditionsbreast cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- breast cancer
- Sponsor
- Shanghai First Maternal and Infant Health Care Hospital
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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