NCT05866029Recruiting
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)
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2478 (estimated)
- First submitted
- 28 Apr 2023
- Start date
- 26 May 2023
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT05866029
What you commit to
- Study type: Interventional
- Planned participants: 2478
- From 26 May 2023 to the primary completion date, 30 Sept 2026
- 58 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously received external radiation or radiation therapy with bone implants;
- Participating in clinical trials of other drugs at present;
Other illness
- bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia;
- Active infection that requires systematic treatment;
- Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment;
- Allergic to teriparatide and denosumab;
Lab values
- GFR\<30ml/min/1.73m2;
- Unexplained elevation of alkaline phosphatase;
- Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin \> 8.5%, and severe arrhythmias;
Other
- Having primary hyperparathyroidism or hypothyroidism;
- Had or have osteomyelitis of the jaw or necrosis of the jaw;
- Used intravenous bisphosphonate, fluoride, or strontium for osteoporosis within 2 years;
- Used teriparatide and denosumab for osteoporosis within 6 months;
- Used glucocorticoids (equivalent to \>5 mg/day prednisone) for more than 10 days within 6 weeks;
- 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) ;
- Have hypocalcemia and hypercalcemia;
- A serious deficiency of vitamin D (25OHD \<10ng/mL);
- Planned pregnancy and lactation at present or during the study period;
- subjects do not suitable for this study
Who the study is looking for
- New brittle hip fractures;
- New brittle vertebral fractures;
- New other site fractures and/or total hip or neck of femur or L1-L4 T-value \< -1.0;
- Men or postmenopausal women;
- Age 45-90 years old;
- Ability to move autonomously
Age in the registry: 45 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (58)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Shijingshan Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Yanhua Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Pinggu Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Jilin Province FAW General Hospital Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Changzhou NO.2 People&#39;s Hospital Coordinator of this site? Confirm its status | Changzhou | China | Recruiting |
| The First People&#39;s Hospital of Changzhou Coordinator of this site? Confirm its status | Changzhou | China | Recruiting |
| West China Fourth Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The Second People&#39;s Hospital of Dalian Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| Shengli Oilfield Central Hospital Coordinator of this site? Confirm its status | Dongying | China | Recruiting |
| Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| Zhejiang Provincial People&#39;s Hospital Bijie Hospital Coordinator of this site? Confirm its status | Guizhou | China | Recruiting |
| The Second Hospital of Jilin University Coordinator of this site? Confirm its status | Haerbin | China | Recruiting |
| The Fourth Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Haerbin | China | Recruiting |
| Zhejiang Provincial People&#39;s Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital of USTC(Anhui Provincial Hospital) Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Affiliated Hospital of Inner Mongolia Medical University Coordinator of this site? Confirm its status | Hohhot | China | Recruiting |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| The Second Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Affiliated Hospital of Jining Medical University Coordinator of this site? Confirm its status | Jining | China | Recruiting |
| Gansu Provincial Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Recruiting |
| Liaocheng People&#39;s Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Recruiting |
| Jiangxi Provincial People&#39;s Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Zhongda Hospital Southeast University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Ningbo No.2 Hospital Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| QingDao Municipal Hospital Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Tongji Hospital of Tongji University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Changhai Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Huadong Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Sixth People&#39;s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The Seventh Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Huazhong University of Science and Technology Union Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Shenzhen Shiyan People&#39;s Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Hebei medical university third hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| The First People&#39;s Hospital of Kunshan Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| The Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Kunshan Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Second hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| First Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| The First Affiliated Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Recruiting |
| Weifang People&#39;s Hospital Coordinator of this site? Confirm its status | Weifang | China | Recruiting |
| The Second Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Qinghai university affiliated hospital Coordinator of this site? Confirm its status | Xining | China | Recruiting |
| People&#39;s Hospital of Ningxia Hui Autonomous Region Coordinator of this site? Confirm its status | Yinchuan | China | Recruiting |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Recruiting |
| Henan Provincial General Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| The Fifth Affiliated Hospital Sun Yat-sen University Coordinator of this site? Confirm its status | Zhuhai | China | Recruiting |
| PKUCare Luzhong Hospital Coordinator of this site? Confirm its status | Zibo | China | Recruiting |
| Zibo Central hospital Coordinator of this site? Confirm its status | Zibo | China | Recruiting |
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This page is information, not medical advice. Discuss any trial with your doctor.