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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003576
Enrollment
Unknown
Registered
2020-08-16
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Sponsors

Shanghai First Maternal and Infant Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 70 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
hepatorenal function;BMD;

Countries

China

Contacts

Public ContactZhuang Zhigang
zhuangzhigang@51mch.com+86 13371985057

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026