Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy
NCT ID: NCT02455154
Last Updated: 2020-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
278 participants
INTERVENTIONAL
2015-05-31
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Letrozole
Early Breast Cancer patients receiving adjuvant endocrine therapy
Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po.
Letrozole
Letrozole endocrine therapy for 2.5mg qd po.
Letrozole + Xinglinggubao
Early Breast Cancer patients receiving adjuvant endocrine therapy plus Xianlinggubao
Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po.
Xinglinggubao: 0.5g bid po
Letrozole
Letrozole endocrine therapy for 2.5mg qd po.
Xianlinggubao
Traditional Chinese Medicine for patients with Osteoporosis
Letrozole + Zhongyaofufang
Early Breast Cancer patients receiving adjuvant endocrine therapyplus Zhongyaofufang (Traditional Chinses Medicine)
Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po.
Zhongyaofufang: qow po
Letrozole
Letrozole endocrine therapy for 2.5mg qd po.
Zhongyaofufang
Traditional Chinese Medicine for patients with Osteoporosis
Interventions
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Letrozole
Letrozole endocrine therapy for 2.5mg qd po.
Zhongyaofufang
Traditional Chinese Medicine for patients with Osteoporosis
Xianlinggubao
Traditional Chinese Medicine for patients with Osteoporosis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
FEMALE
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Kunwei Shen
Professor
Principal Investigators
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Kunwei Shen, MD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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RJBC1502
Identifier Type: -
Identifier Source: org_study_id
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