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Clinical Trials in China / NCT05866029
Recruiting Not applicable

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

NCT05866029 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Not applicable
Started
2023-05-26
Last updated
2026-01-12

Condition(s) studied

Osteoporotic Fractures

Investigational drug(s) / intervention(s)

DenosumabTeriparatide

Denosumab: Active Comparator: 60mg of Denosumab treatment by subcutaneous injection

Teriparatide: Teriparatide was sequentially treated with Denosumab

Study summary

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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
90 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (58)

FacilityCityRegionStatus
Beijing Friendship Hospital, Capital Medical University Beijing China Recruiting
Beijing Hospital Beijing China Recruiting
Beijing Pinggu Hospital Beijing China Recruiting
Beijing Shijingshan Hospital Beijing China Recruiting
Beijing Yanhua Hospital Beijing China Recruiting
Peking Union Medical College Hospital Beijing China Recruiting
Peking University Third Hospital Beijing China Recruiting
Jilin Province FAW General Hospital Changchun China Recruiting
The Second XIANGYA Hospital of Central South University Changsha China Recruiting
Changzhou NO.2 People&amp;#39;s Hospital Changzhou China Recruiting
The First People&amp;#39;s Hospital of Changzhou Changzhou China Recruiting
Sichuan Provincial People&#39;s Hospital Chengdu China Recruiting
West China Fourth Hospital of Sichuan University Chengdu China Recruiting
The Second People&amp;#39;s Hospital of Dalian Dalian China Recruiting
Shengli Oilfield Central Hospital Dongying China Recruiting
Affiliated Hospital of Guizhou Medical University Guiyang China Recruiting
Zhejiang Provincial People&amp;#39;s Hospital Bijie Hospital Guizhou China Recruiting
The Fourth Hospital of Harbin Medical University Haerbin China Recruiting
The Second Hospital of Jilin University Haerbin China Recruiting
Zhejiang Provincial People&amp;#39;s Hospital Hangzhou China Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei China Recruiting
The First Affiliated Hospital of USTC (Anhui Provincial Hospital) Hefei China Recruiting
Affiliated Hospital of Inner Mongolia Medical University Hohhot China Recruiting
Shandong Provincial Hospital Jinan China Recruiting
The Second Hospital of Shandong University Jinan China Recruiting
Affiliated Hospital of Jining Medical University Jining China Recruiting
Gansu Provincial Hospital Lanzhou China Recruiting
Liaocheng People&amp;#39;s Hospital Liaocheng China Recruiting
Jiangxi Provincial People&amp;#39;s Hospital Nanchang China Recruiting
Zhongda Hospital Southeast University Nanjing China Recruiting
Ningbo NO.2 Hospital Ningbo China Recruiting
Qingdao Municipal Hospital Qingdao China Recruiting
Changhai Hospital Shanghai China Recruiting
Huadong Hospital Affiliated to Fudan University Shanghai China Recruiting
Shanghai Changzheng Hospital Shanghai China Recruiting
Shanghai General Hospital Shanghai China Recruiting
Shanghai Sixth People&amp;#39;s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai China Recruiting
Tongji Hospital of Tongji University Shanghai China Recruiting
Huazhong University of Science and Technology Union Shenzhen Hospital Shenzhen China Recruiting
Shenzhen Shiyan People&amp;#39;s Hospital Shenzhen China Recruiting

+ 18 more sites — see the full list on the official registry below.

More Peking Union Medical College Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05866029 on ClinicalTrials.gov ↗ ← All trials in China