Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
- Conditions
- Osteoporotic Fractures
- Interventions
- Registration Number
- NCT05866029
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2478
- 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
- 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 β€ 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 60mg of Denosumab treatment Denosumab Monotherapy with denosumab injection ( 60mg, subcutaneous injection, semi-annually) for 24 months. Teriparatide was sequentially treated with Denosumab 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. Teriparatide was sequentially treated with Denosumab Teriparatide 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.
- Primary Outcome Measures
Name Time Method The incidence of new vertebral fractures Within 24 months of treatment The incidence of new vertebral fractures (clinical and imaging) within 24 months of treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (58)
Beijing Friendship Hospital, Capital Medical University
π¨π³Beijing, China
Beijing Hospital
π¨π³Beijing, China
Beijing Pinggu Hospital
π¨π³Beijing, China
Beijing Shijingshan Hospital
π¨π³Beijing, China
Beijing Yanhua Hospital
π¨π³Beijing, China
Peking Union Medical College Hospital
π¨π³Beijing, China
Peking University Third Hospital
π¨π³Beijing, China
Jilin Province FAW General Hospital
π¨π³Changchun, China
The Second XIANGYA Hospital of Central South University
π¨π³Changsha, China
Changzhou NO.2 People&#39;s Hospital
π¨π³Changzhou, China
Affiliated Hospital of Jining Medical University
π¨π³Jining, China
Gansu Provincial Hospital
π¨π³Lanzhou, China
Liaocheng People&#39;s Hospital
π¨π³Liaocheng, China
Jiangxi Provincial People&#39;s Hospital
π¨π³Nanchang, China
The First People&#39;s Hospital of Changzhou
π¨π³Changzhou, China
Sichuan Provincial People's Hospital
π¨π³Chengdu, China
West China Fourth Hospital of Sichuan University
π¨π³Chengdu, China
The Second People&#39;s Hospital of Dalian
π¨π³Dalian, China
Shengli Oilfield Central Hospital
π¨π³Dongying, China
Affiliated Hospital of Guizhou Medical University
π¨π³Guiyang, China
Zhejiang Provincial People&#39;s Hospital Bijie Hospital
π¨π³Guizhou, China
The Fourth Hospital of Harbin Medical University
π¨π³Haerbin, China
The Second Hospital of Jilin University
π¨π³Haerbin, China
Zhejiang Provincial People&#39;s Hospital
π¨π³Hangzhou, China
The First Affiliated Hospital of Anhui Medical University
π¨π³Hefei, China
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
π¨π³Hefei, China
Affiliated Hospital of Inner Mongolia Medical University
π¨π³Hohhot, China
Shandong Provincial Hospital
π¨π³Jinan, China
The Second Hospital of Shandong University
π¨π³Jinan, China
Zhongda Hospital Southeast University
π¨π³Nanjing, China
Ningbo NO.2 Hospital
π¨π³Ningbo, China
Qingdao Municipal Hospital
π¨π³Qingdao, China
The First Affiliated Hospital of Xinjiang Medical University
π¨π³Urumqi, China
Weifang People&#39;s Hospital
π¨π³Weifang, China
The Second Affiliated Hospital of Wenzhou Medical University
π¨π³Wenzhou, China
Qinghai University Affiliated Hospital
π¨π³Xining, China
Changhai Hospital
π¨π³Shanghai, China
Huadong Hospital Affiliated to Fudan University
π¨π³Shanghai, China
Shanghai Changzheng Hospital
π¨π³Shanghai, China
Shanghai General Hospital
π¨π³Shanghai, China
Shanghai Sixth People&#39;s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
π¨π³Shanghai, China
Tongji Hospital of Tongji University
π¨π³Shanghai, China
Huazhong University of Science and Technology Union Shenzhen Hospital
π¨π³Shenzhen, China
Shenzhen Shiyan People&#39;s Hospital
π¨π³Shenzhen, China
The Seventh Affiliated Hospital of Sun Yat-sen University
π¨π³Shenzhen, China
Hebei Medical University Third Hospital
π¨π³Shijiazhuang, China
Kunshan Hospital of Traditional Chinese Medicine
π¨π³Suzhou, China
The First People&#39;s Hospital of Kunshan
π¨π³Suzhou, China
The Second Affiliated Hospital of Soochow University
π¨π³Suzhou, China
First Hospital of Shanxi Medical University
π¨π³Taiyuan, China
Second Hospital of Shanxi Medical University
π¨π³Taiyuan, China
General Hospital of Ningxia Medical University
π¨π³Yinchuan, China
People&#39;s Hospital of Ningxia Hui Autonomous Region
π¨π³Yinchuan, China
Henan Provincial General Hospital
π¨π³Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, China
The Fifth Affiliated Hospital Sun Yat-sen University
π¨π³Zhuhai, China
PKUCare Luzhong Hospital
π¨π³Zibo, China
Zibo Central Hospital
π¨π³Zibo, China