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

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

Detailed Description
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Breast cancer is the most common malignant tumor in female wolrdwide. Results from clinical trials like ATAC trial have demonstrated the efficacy of AIs in postmenopausal breast cancer patients. Meanwhile it may cause a certain rate of osteoporosis in postmenopausal patients. The aim of this trial is to test the efficacy of two traditional Chinese medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

Official Title
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Traditional Chinese Medicine as Preventive Method for Osteoporosis in Early Breast Cancer Patients Receiving Adjuvant Endocrine Therapy

Conditions
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Breast Cancer, Osteoporosis

Intervention / Treatment
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* Drug: Letrozole
* Drug: Zhongyaofufang
* Drug: Xianlinggubao


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Letrozole<br>Early Breast Cancer patients receiving adjuvant endocrine therapy Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. | Drug: Letrozole<br>* Letrozole endocrine therapy for 2.5mg qd po.<br>* Other names: L;|
| Active Comparator: Letrozole + Xinglinggubao<br>Early Breast Cancer patients receiving adjuvant endocrine therapy plus Xianlinggubao Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. Xinglinggubao: 0.5g bid po | Drug: Letrozole<br>* Letrozole endocrine therapy for 2.5mg qd po.<br>* Other names: L;Drug: Xianlinggubao<br>* Traditional Chinese Medicine for patients with Osteoporosis<br>* Other names: X;|
| Active Comparator: Letrozole + Zhongyaofufang<br>Early Breast Cancer patients receiving adjuvant endocrine therapyplus Zhongyaofufang (Traditional Chinses Medicine) Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. Zhongyaofufang: qow po | Drug: Letrozole<br>* Letrozole endocrine therapy for 2.5mg qd po.<br>* Other names: L;Drug: Zhongyaofufang<br>* Traditional Chinese Medicine for patients with Osteoporosis<br>* Other names: Z;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Bone Mineral Density | The change of bone mineral density of the L2-L4 region of the spine and hip between pre- and post-endocrine therapy for one year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Frature Rate | the rate of bone fracture in patient receiving endocrine therapy | 1 year | 
| Bone Metabolism | The change of bone metabolism assessed by the scale of serum bone alkaline phosphatase, serum C-telopeptide and urineN-telopeptide between pre- and post-endocrine therapy for one year | 1 year | 
| Disease Free Survival | the rate of patients without disease | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese Traditional Medicine, Osteoporosis, adjuvant endocrine therapy, early breast cancer