Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy

• Status: Completed
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Letrozole

Criteria

Inclusion Criteria:

• Histologically confirmed invasive breast cancer;

• Post-surgery, primary lesion been removed;

• Post-Menopausal patients or pre-menopausal patients who will receive ovarian function suppression;

• Histologically confirmed ER and/or PR positive ;

• Receiving adjuvant AIs therapy in the following one years;

• Leukocyte ≥ 3*10(9)/L; Platelets ≥ 75*10(9)/L;

• Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) <2.5 times of upper limit of normal range;

• Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range;

• Written informed consent according to the local ethics committee equirements;

Exclusion Criteria:

• Metastatic Breast Cancer;

• Received Neo-Adjuvant Endocrine Therapy;

• History of pelvic fracture or bone metabolic disease;

• Received drugs interfering bone metabolism in the last 12 months;

• Baseline Bone Mineral Density: T < -2SD;

• With other primary malignant disease;

• With severe non-malignant co-morbidity that will influence long-term follow up;

• Known severe hypersensitivity to any drugs in this study;