Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
Recruiting · NCT05866029 · Interventional (participants receive a specific treatment) · Lead sponsor: Peking Union Medical College Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Age range
45 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia;
- Having primary hyperparathyroidism or hypothyroidism;
- Had or have osteomyelitis of the jaw or necrosis of the jaw;
- GFR\<30ml/min/1.73m2;
- Active infection that requires systematic treatment;
- 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) ;
- Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment;
- Have hypocalcemia and hypercalcemia;
- Unexplained elevation of alkaline phosphatase;
- A serious deficiency of vitamin D (25OHD \<10ng/mL);
- Patients who have previously received external radiation or radiation therapy with bone implants;
- Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin \> 8.5%, and severe arrhythmias;
- Planned pregnancy and lactation at present or during the study period;
- Allergic to teriparatide and denosumab;
- Participating in clinical trials of other drugs at present;
- subjects do not suitable for this study
Where it is running
58 locations listed.
- 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
- 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
- The First Affiliated Hospital of Xinjiang Medical University - Ürümqi, China