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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60mg of Denosumab treatment | Active Comparator | Monotherapy with denosumab injection ( 60mg, subcutaneous injection, semi-annually) for 24 months. |
|
| Teriparatide was sequentially treated with Denosumab | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | Active Comparator: 60mg of Denosumab treatment by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The main study:The incidence of new vertebral fractures | The main study:the incidence of new vertebral fractures (clinical and imaging) within 24 months of treatment | Within 24 months of treatment |
| The sub study:The rate of change in BMD from baseline at lumbar spine in 24 months | Within 24 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The main study:New vertebral fractures in 12 months | Within 12 months of treatment | |
| The main study:New hip fractures, new fractures at other sites, and all new fractures at 12 and 24 months | Within 12 months and 24 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weibo Xia | Contact | 13501002126 | xiaweibo8301@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weibo Xia, MD. | Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41748193 | Derived | Chi Y, Zhu Y, Yuan J, Pang Q, Cui L, Jiang Y, Jiajue R, Liu W, Wang O, Li M, Xing X, Li H, Xie G, Wu Y, Xia W. 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 multicentre randomised controlled trial (STAND study) protocol. BMJ Open. 2026 Feb 26;16(2):e111364. doi: 10.1136/bmjopen-2025-111364. |
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Data related to this study will be made available upon reasonable request.
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| Teriparatide | Drug | Teriparatide was sequentially treated with Denosumab |
|
| The main study:The rate of BMD change from the baseline at the lumbar spine, total hip, and femoral neck in 12 and 24 months; | Within 12 months and 24 months of treatment |
| The main study:The rate of changes from baseline in serum type 1 collagen cross-linked C-terminal peptide (β-CTX) and type 1 procollagen N-terminal propeptide (P1NP) at 6, 12, and 24 months | 6, 12, and 24 months |
| The main study:The patients' adherence to treatment | Non-adherence rate=Number of patients non-adherencet with teriparatide or denosumab / Total number of patients.
| 24 months |
| The main study:Cost-effectiveness | The incremental cost-effectiveness ratio is defined as the average additional drug cost required per additional fracture event avoided in the intervention group compared to the control group. | 24 months |
| The sub study:BMD change at lumbar spine in 12 months | Within 12 months of treatment |
| The sub study:BMD changes at total hip and femoral neck in 12 and 24 months | Within 12 months and 24 months of treatment |
| The sub study:Serum β-CTX and P1NP levels at 12 and 24 months | 12 months and 24 months |
| The sub study:The incidence of new vertebral fractures, hip fractures, new fractures at other sites, and all new fractures in 12 and 24 months | Within 12 months and 24 months of treatment |
| Beijing Hospital | Recruiting | Beijing | China |
|
| Beijing Pinggu Hospital | Recruiting | Beijing | China |
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| Beijing Shijingshan Hospital | Recruiting | Beijing | China |
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| Beijing Yanhua Hospital | Recruiting | Beijing | China |
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| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| Peking University Third Hospital | Recruiting | Beijing | China |
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| Jilin Province FAW General Hospital | Recruiting | Changchun | China |
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| The Second XIANGYA Hospital of Central South University | Recruiting | Changsha | China |
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| Changzhou NO.2 People's Hospital | Recruiting | Changzhou | China |
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| The First People's Hospital of Changzhou | Recruiting | Changzhou | China |
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| Sichuan Provincial People's Hospital | Recruiting | Chengdu | China |
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| West China Fourth Hospital of Sichuan University | Recruiting | Chengdu | China |
|
| The Second People's Hospital of Dalian | Recruiting | Dalian | China |
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| Shengli Oilfield Central Hospital | Recruiting | Dongying | China |
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| Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | China |
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| Zhejiang Provincial People's Hospital Bijie Hospital | Recruiting | Guizhou | China |
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| The Fourth Hospital of Harbin Medical University | Recruiting | Haerbin | China |
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| The Second Hospital of Jilin University | Recruiting | Haerbin | China |
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| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | China |
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| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | China |
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| The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | Recruiting | Hefei | China |
|
| Affiliated Hospital of Inner Mongolia Medical University | Recruiting | Hohhot | China |
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| Shandong Provincial Hospital | Recruiting | Jinan | China |
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| The Second Hospital of Shandong University | Recruiting | Jinan | China |
|
| Affiliated Hospital of Jining Medical University | Recruiting | Jining | China |
|
| Gansu Provincial Hospital | Recruiting | Lanzhou | China |
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| Liaocheng People's Hospital | Recruiting | Liaocheng | China |
|
| Jiangxi Provincial People's Hospital | Recruiting | Nanchang | China |
|
| Zhongda Hospital Southeast University | Recruiting | Nanjing | China |
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| Ningbo NO.2 Hospital | Recruiting | Ningbo | China |
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| Qingdao Municipal Hospital | Recruiting | Qingdao | China |
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| Changhai Hospital | Recruiting | Shanghai | China |
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| Huadong Hospital Affiliated to Fudan University | Recruiting | Shanghai | China |
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| Shanghai Changzheng Hospital | Recruiting | Shanghai | China |
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| Shanghai General Hospital | Recruiting | Shanghai | China |
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| Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
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| Tongji Hospital of Tongji University | Recruiting | Shanghai | China |
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| Huazhong University of Science and Technology Union Shenzhen Hospital | Recruiting | Shenzhen | China |
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| Shenzhen Shiyan People's Hospital | Recruiting | Shenzhen | China |
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| The Seventh Affiliated Hospital of Sun Yat-sen University | Recruiting | Shenzhen | China |
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| Hebei Medical University Third Hospital | Recruiting | Shijiazhuang | China |
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| Kunshan Hospital of Traditional Chinese Medicine | Recruiting | Suzhou | China |
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| The First People's Hospital of Kunshan | Recruiting | Suzhou | China |
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| The Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | China |
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| First Hospital of Shanxi Medical University | Recruiting | Taiyuan | China |
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| Second Hospital of Shanxi Medical University | Recruiting | Taiyuan | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | China |
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| Weifang People's Hospital | Recruiting | Weifang | China |
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| The Second Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | China |
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| Qinghai University Affiliated Hospital | Recruiting | Xining | China |
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| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | China |
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| People's Hospital of Ningxia Hui Autonomous Region | Recruiting | Yinchuan | China |
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| Henan Provincial General Hospital | Recruiting | Zhengzhou | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | China |
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| The Fifth Affiliated Hospital Sun Yat-sen University | Recruiting | Zhuhai | China |
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| PKUCare Luzhong Hospital | Recruiting | Zibo | China |
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| Zibo Central Hospital | Recruiting | Zibo | China |
|
| ID | Term |
|---|---|
| D058866 | Osteoporotic Fractures |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
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