Osteoporosis
Conditions
Interventions
Denosumab group:Denosumab 60mg SC / 6 months
Zoledronic acid group:Zoledronic acid 5mg IV / 12months
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study, sign informed consent, are willing and able to comply with the treatment plan, examination and follow-up; 2. Women with histologically determined non-metastatic estrogen receptor-positive or progesterone receptor-positive early breast cancer (stage I,II,IIIA) who have completed local regional therapy (surgery, chemotherapy, radiotherapy, etc.) and are receiving or will begin adjuvant aromatase inhibitor therapy;; 3. Postmenopausal status: if a woman underwent bilateral oophorectomy; aged 60 years or older; or younger than 60 years, after or without medical castration (such as GnRHa), their follicle-stimulating hormone and estradiol levels are in the postmenopausal range, it is defined as postmenopausal status; 4. Bone mineral density T value 65 years; (3) Low BMI ( 6 months; (6) Smoking (smoking and smoking history); 5. Serum calcium higher than 2.1 mmol/L; 6. 25-hydroxyvitamin D higher than 12 ng/mL; 7. ECOG score 0, 1, and 2.
Exclusion criteria
Exclusion criteria: 1. Evidence of metastatic disease; 2. Known allergy to denosumab; 3. Known allergy to zoledronic acid; 4. Zoledronic acid group should be excluded from receiving bisphosphonates for more than 3 years, or bisphosphonates for less than 3 years but less than 12 months; 5. Known Paget's disease (bone damage), Cushing's syndrome, hyperprolactinemia, multiple myeloma or other active metabolic bone disease, uncorrectable hypercalcemia or hypocalcemia; 6. Zoledronic acid group is not included in patients with severe renal insufficiency (creatinine clearance < 35 mL/min); 7. Serum calcium is still less than 2.1 mmol/L after calcium supplementation; 8. 25-hydroxyvitamin D is still less than 12 ng/ml after vitamin D supplementation. 9. Suffering from mental illness or other conditions, such as uncontrollable heart disease or lung disease, diabetes, etc., can not cooperate with the study treatment and monitoring requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bone mineral density at lumber spine; | — |
Secondary
| Measure | Time frame |
|---|---|
| bone mineral density at total hip;New vertebral or hip fracture;Bone turnover markers; | — |
Countries
China
Contacts
Public ContactBo Chen
The First Hospital of China Medical University
Outcome results
None listed