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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02455154

Acronym

COAT

Enrollment

278

Registered

2015-05-27

Start date

2015-05-31

Completion date

2019-09-30

Last updated

2020-04-14

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

Conditions

Breast Cancer, Osteoporosis

Keywords

Chinese Traditional Medicine, Osteoporosis, adjuvant endocrine therapy, early breast cancer

Brief summary

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

Detailed description

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.

Interventions

DRUGLetrozole

Letrozole endocrine therapy for 2.5mg qd po.

DRUGZhongyaofufang

Traditional Chinese Medicine for patients with Osteoporosis

DRUGXianlinggubao

Traditional Chinese Medicine for patients with Osteoporosis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
Change of Bone Mineral Density	1 year	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

Secondary

Measure	Time frame	Description
Bone Frature Rate	1 year	the rate of bone fracture in patient receiving endocrine therapy
Bone Metabolism	1 year	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
Disease Free Survival	1 year	the rate of patients without disease

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026