Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
NCT ID: NCT05866029
Last Updated: 2026-01-12
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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RECRUITING
NA
2478 participants
INTERVENTIONAL
2023-05-26
2026-09-30
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
TREATMENT
SINGLE
Study Groups
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60mg of Denosumab treatment
Monotherapy with denosumab injection ( 60mg, subcutaneous injection, semi-annually) for 24 months.
Denosumab
Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
Teriparatide was sequentially treated with Denosumab
1. Treatment with teriparatide injection ( 20ug, subcutaneous injection, once daily) for 6 months, followed by discontinuation of teriparatide and change to denosumab injection ( 60mg, subcutaneous injection, once every six months) and continued until the 24th month.
2. Treatment with teriparatide injection ( 20ug, subcutaneous injection, once daily) for 12 months, followed by discontinuation of teriparatide and change to denosumab injection ( 60mg, subcutaneous injection, semi-annually) treatment continued until the 24th month.
Denosumab
Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
Teriparatide
Teriparatide was sequentially treated with Denosumab
Interventions
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Denosumab
Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
Teriparatide
Teriparatide was sequentially treated with Denosumab
Eligibility Criteria
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Inclusion Criteria
2. New brittle vertebral fractures;
3. New other site fractures and/or total hip or neck of femur or L1-L4 T-value \< -1.0;
4. Men or postmenopausal women;
5. Age 45-90 years old;
6. Ability to move autonomously
Exclusion Criteria
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 \>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 \<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 \> 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
45 Years
90 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Weibo Xia, MD.
Role: STUDY_CHAIR
Peking Union Medical College Hospital
Locations
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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&#39;s Hospital
Changzhou, , China
The First People&#39;s Hospital of Changzhou
Changzhou, , China
Sichuan Provincial People's Hospital
Chengdu, , China
West China Fourth Hospital of Sichuan University
Chengdu, , China
The Second People&#39;s Hospital of Dalian
Dalian, , China
Shengli Oilfield Central Hospital
Dongying, , China
Affiliated Hospital of Guizhou Medical University
Guiyang, , China
Zhejiang Provincial People&#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&#39;s Hospital
Hangzhou, , China
The First Affiliated Hospital of Anhui Medical University
Hefei, , China
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, , China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, , China
Shandong Provincial Hospital
Jinan, , China
The Second Hospital of Shandong University
Jinan, , China
Affiliated Hospital of Jining Medical University
Jining, , China
Gansu Provincial Hospital
Lanzhou, , China
Liaocheng People&#39;s Hospital
Liaocheng, , China
Jiangxi Provincial People&#39;s Hospital
Nanchang, , China
Zhongda Hospital Southeast University
Nanjing, , China
Ningbo NO.2 Hospital
Ningbo, , China
Qingdao Municipal Hospital
Qingdao, , China
Changhai Hospital
Shanghai, , China
Huadong Hospital Affiliated to Fudan University
Shanghai, , China
Shanghai Changzheng Hospital
Shanghai, , China
Shanghai General Hospital
Shanghai, , China
Shanghai Sixth People&#39;s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Tongji Hospital of Tongji University
Shanghai, , China
Huazhong University of Science and Technology Union Shenzhen Hospital
Shenzhen, , China
Shenzhen Shiyan People&#39;s Hospital
Shenzhen, , China
The Seventh Affiliated Hospital of Sun Yat-sen University
Shenzhen, , China
Hebei Medical University Third Hospital
Shijiazhuang, , China
Kunshan Hospital of Traditional Chinese Medicine
Suzhou, , China
The First People&#39;s Hospital of Kunshan
Suzhou, , China
The Second Affiliated Hospital of Soochow University
Suzhou, , China
First Hospital of Shanxi Medical University
Taiyuan, , China
Second Hospital of Shanxi Medical University
Taiyuan, , China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, , China
Weifang People&#39;s Hospital
Weifang, , China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Qinghai University Affiliated Hospital
Xining, , China
General Hospital of Ningxia Medical University
Yinchuan, , China
People&#39;s Hospital of Ningxia Hui Autonomous Region
Yinchuan, , China
Henan Provincial General Hospital
Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
The Fifth Affiliated Hospital Sun Yat-sen University
Zhuhai, , China
PKUCare Luzhong Hospital
Zibo, , China
Zibo Central Hospital
Zibo, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-PUMCH-D-006
Identifier Type: -
Identifier Source: org_study_id
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