Clinical trial NCT05866029: Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
Official title: Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoporotic Fractures
Keywords: osteoporosis
osteoporotic fractures
bone turnover markers
imaging biomarkers
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 2478
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. New brittle hip fractures;
2. New brittle vertebral fractures;
3. New other site fractures and/or total hip or neck of femur or L1-L4 T-value \&lt; -1.0;
4. Men or postmenopausal women;
5. Age 45-90 years old;
6. Ability to move autonomously

Exclusion Criteria:

1. bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia;
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 \&gt;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 \&lt;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 \&gt; 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

Primary outcomes:
measure: The incidence of new vertebral fractures
timeFrame: Within 24 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Beijing
country: China
facility: Beijing Shijingshan Hospital
city: Beijing
country: China
facility: Beijing Yanhua Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changchun
country: China
facility: Jilin Province FAW General Hospital
city: Changsha
country: China
facility: The Second XIANGYA Hospital of Central South University
city: Changzhou
country: China
facility: Changzhou NO.2 People&amp;#39;s Hospital
city: Changzhou
country: China
facility: The First People&amp;#39;s Hospital of Changzhou
city: Chengdu
country: China
facility: Sichuan Provincial People&#39;s Hospital
city: Chengdu
country: China
facility: West China Fourth Hospital of Sichuan University
city: Dalian
country: China
facility: The Second People&amp;#39;s Hospital of Dalian
city: Dongying
country: China
facility: Shengli Oilfield Central Hospital
city: Guiyang
country: China
facility: Affiliated Hospital of Guizhou Medical University
city: Guizhou
country: China
facility: Zhejiang Provincial People&amp;#39;s Hospital Bijie Hospital
city: Haerbin
country: China
facility: The Fourth Hospital of Harbin Medical University
city: Haerbin
country: China
facility: The Second Hospital of Jilin University
city: Hangzhou
country: China
facility: Zhejiang Provincial People&amp;#39;s Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
city: Hohhot
country: China
facility: Affiliated Hospital of Inner Mongolia Medical University
city: Jinan
country: China
facility: Shandong Provincial Hospital
city: Jinan
country: China
facility: The Second Hospital of Shandong University
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
city: Liaocheng
country: China
facility: Liaocheng People&amp;#39;s Hospital
city: Nanchang
country: China
facility: Jiangxi Provincial People&amp;#39;s Hospital
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Ningbo
country: China
facility: Ningbo NO.2 Hospital
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shanghai
country: China
facility: Shanghai Sixth People&amp;#39;s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
city: Shenzhen
country: China
facility: Huazhong University of Science and Technology Union Shenzhen Hospital
city: Shenzhen
country: China
facility: Shenzhen Shiyan People&amp;#39;s Hospital
city: Shenzhen
country: China
facility: The Seventh Affiliated Hospital of Sun Yat-sen University
city: Shijiazhuang
country: China
facility: Hebei Medical University Third Hospital
city: Suzhou
country: China
facility: Kunshan Hospital of Traditional Chinese Medicine
city: Suzhou
country: China
facility: The First People&amp;#39;s Hospital of Kunshan
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
city: Weifang
country: China
facility: Weifang People&amp;#39;s Hospital
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Yinchuan
country: China
facility: People&amp;#39;s Hospital of Ningxia Hui Autonomous Region
city: Zhengzhou
country: China
facility: Henan Provincial General Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital Sun Yat-sen University
city: Zibo
country: China
facility: PKUCare Luzhong Hospital
city: Zibo
country: China
facility: Zibo Central Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Weibo Xia, MD.
role: STUDY_CHAIR
References: