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RECRUITINGINTERVENTIONAL

Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture

Efficacy of Sequential Denosumab After Teriparatide for 6 Months Compared With Denosumab Monotherapy in Reducing Risk of Osteoporotic Fractures in Patients With New Fractures: a Multicenter Randomized Controlled Trial (STAND Study)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This project anchors osteoporotic fractures, conduct registration and follow-up studies, and conduct prospective treatment studies. By registering for follow-up studies on osteoporotic fractures, it is planned to obtain epidemiological data through registration and follow-up studies; A prospective treatment study for patients with osteoporotic fractures is planned to explore effective treatment strategies through randomized controlled trials; To study biomarkers for osteoporotic refractures, we plan to establish a biomarker warning model through multi omics research; To study imaging biomarkers for osteoporotic refractures, a new imaging technology is proposed to establish an imaging omics warning model.

Who May Be Eligible (Plain English)

Who May Qualify: 1. New brittle hip fractures; 2. New brittle vertebral fractures; 3. New other site fractures and/or total hip or neck of femur or L1-L4 T-value \&lt; -1.0; 4. Men or postmenopausal women; 5. Age 45-90 years old; 6. Ability to move autonomously Who Should NOT Join This Trial: 1. bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia; 2. Having primary hyperparathyroidism or hypothyroidism; 3. Had or have osteomyelitis of the jaw or necrosis of the jaw; 4. GFR\<30ml/min/1.73m2; 5. Active infection that requires systematic treatment; 6. Used intravenous bisphosphonate, fluoride, or strontium for osteoporosis within 2 years; 7. Used teriparatide and denosumab for osteoporosis within 6 months; 8. Used glucocorticoids (equivalent to \&gt;5 mg/day prednisone) for more than 10 days within 6 weeks; 9. The time gap between the first time and the last time oral bisphosphonate for osteoporosis less than 1 year( if used within one year, but the cumulative use is ≤ 1 month, the subject can be enrolled) ; 10. Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment; 11. Have hypocalcemia and hypercalcemia; 12. Unexplained elevation of alkaline phosphatase; 13. A serious deficiency of vitamin D (25OHD \&lt;10ng/mL); 14. Patients who have previously received external radiation or radiation therapy with bone implants; 15. Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin \&gt; 8.5%, and severe arrhythmias; 16. Planned pregnancy and lactation at present or during the study period; 17. Allergic to teriparatide and denosumab; 18. Participating in clinical trials of other drugs at present; 19. subjects do not suitable for this study Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. New brittle hip fractures; 2. New brittle vertebral fractures; 3. New other site fractures and/or total hip or neck of femur or L1-L4 T-value \&lt; -1.0; 4. Men or postmenopausal women; 5. Age 45-90 years old; 6. Ability to move autonomously Exclusion Criteria: 1. bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia; 2. Having primary hyperparathyroidism or hypothyroidism; 3. Had or have osteomyelitis of the jaw or necrosis of the jaw; 4. GFR\<30ml/min/1.73m2; 5. Active infection that requires systematic treatment; 6. Used intravenous bisphosphonate, fluoride, or strontium for osteoporosis within 2 years; 7. Used teriparatide and denosumab for osteoporosis within 6 months; 8. Used glucocorticoids (equivalent to \&gt;5 mg/day prednisone) for more than 10 days within 6 weeks; 9. The time gap between the first time and the last time oral bisphosphonate for osteoporosis less than 1 year( if used within one year, but the cumulative use is ≤ 1 month, the subject can be enrolled) ; 10. Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment; 11. Have hypocalcemia and hypercalcemia; 12. Unexplained elevation of alkaline phosphatase; 13. A serious deficiency of vitamin D (25OHD \&lt;10ng/mL); 14. Patients who have previously received external radiation or radiation therapy with bone implants; 15. Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin \&gt; 8.5%, and severe arrhythmias; 16. Planned pregnancy and lactation at present or during the study period; 17. Allergic to teriparatide and denosumab; 18. Participating in clinical trials of other drugs at present; 19. subjects do not suitable for this study

Treatments Being Tested

DRUG

Denosumab

Active Comparator: 60mg of Denosumab treatment by subcutaneous injection

DRUG

Teriparatide

Teriparatide was sequentially treated with Denosumab

Locations (20)

Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
Beijing Pinggu Hospital
Beijing, China
Beijing Shijingshan Hospital
Beijing, China
Beijing Yanhua Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Jilin Province FAW General Hospital
Changchun, China
The Second XIANGYA Hospital of Central South University
Changsha, China
Changzhou NO.2 People&amp;#39;s Hospital
Changzhou, China
The First People&amp;#39;s Hospital of Changzhou
Changzhou, China
Sichuan Provincial People&#39;s Hospital
Chengdu, China
West China Fourth Hospital of Sichuan University
Chengdu, China
The Second People&amp;#39;s Hospital of Dalian
Dalian, China
Shengli Oilfield Central Hospital
Dongying, China
Affiliated Hospital of Guizhou Medical University
Guiyang, China
Zhejiang Provincial People&amp;#39;s Hospital Bijie Hospital
Guizhou, China
The Fourth Hospital of Harbin Medical University
Haerbin, China
The Second Hospital of Jilin University
Haerbin, China
Zhejiang Provincial People&amp;#39;s Hospital
Hangzhou, China