Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture

Last updated: October 22, 2024
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Treatment

Teriparatide

Denosumab

Clinical Study ID

NCT05866029
2022-PUMCH-D-006
  • Ages 45-90
  • All Genders

Study 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

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 < -1.0;

  4. Men or postmenopausal women;

  5. Age 45-90 years old;

  6. Ability to move autonomously

Exclusion

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 2years;

  7. Used teriparatide and denosumab for osteoporosis within 6 months;

  8. Used glucocorticoids (equivalent to &gt;5 mg/day prednisone) for more than 10 dayswithin 6 weeks;

  9. The time gap between the first time and the last time oral bisphosphonate forosteoporosis 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 thatare 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 withbone implants;

  15. Uncontrolled comorbidities included heart failure above the New York cardiacFunction 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

Study Design

Total Participants: 2478
Treatment Group(s): 2
Primary Treatment: Teriparatide
Phase:
Study Start date:
May 26, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Beijing Friendship Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • Beijing Hospital

    Beijing,
    China

    Active - Recruiting

  • Beijing Pinggu Hospital

    Beijing,
    China

    Active - Recruiting

  • Beijing Shijingshan Hospital

    Beijing,
    China

    Active - Recruiting

  • Beijing Yanhua Hospital

    Beijing,
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing,
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing,
    China

    Active - Recruiting

  • Jilin Province FAW General Hospital

    Changchun,
    China

    Active - Recruiting

  • The Second XIANGYA Hospital of Central South University

    Changsha,
    China

    Active - Recruiting

  • Changzhou NO.2 People&amp;#39;s Hospital

    Changzhou,
    China

    Active - Recruiting

  • The First People&amp;#39;s Hospital of Changzhou

    Changzhou,
    China

    Active - Recruiting

  • Sichuan Provincial People&#39;s Hospital

    Chengdu,
    China

    Active - Recruiting

  • West China Fourth Hospital of Sichuan University

    Chengdu,
    China

    Active - Recruiting

  • The Second People&amp;#39;s Hospital of Dalian

    Dalian,
    China

    Active - Recruiting

  • Shengli Oilfield Central Hospital

    Dongying,
    China

    Active - Recruiting

  • Affiliated Hospital of Guizhou Medical University

    Guiyang,
    China

    Active - Recruiting

  • Zhejiang Provincial People&amp;#39;s Hospital Bijie Hospital

    Guizhou,
    China

    Active - Recruiting

  • The Fourth Hospital of Harbin Medical University

    Haerbin,
    China

    Active - Recruiting

  • The Second Hospital of Jilin University

    Haerbin,
    China

    Active - Recruiting

  • Zhejiang Provincial People&amp;#39;s Hospital

    Hangzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei,
    China

    Active - Recruiting

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Hefei,
    China

    Active - Recruiting

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot,
    China

    Active - Recruiting

  • Shandong Provincial Hospital

    Jinan,
    China

    Active - Recruiting

  • The Second Hospital of Shandong University

    Jinan,
    China

    Active - Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining,
    China

    Active - Recruiting

  • Gansu Provincial Hospital

    Lanzhou,
    China

    Active - Recruiting

  • Liaocheng People&amp;#39;s Hospital

    Liaocheng,
    China

    Active - Recruiting

  • Jiangxi Provincial People&amp;#39;s Hospital

    Nanchang,
    China

    Active - Recruiting

  • Zhongda Hospital Southeast University

    Nanjing,
    China

    Active - Recruiting

  • Ningbo NO.2 Hospital

    Ningbo,
    China

    Active - Recruiting

  • Qingdao Municipal Hospital

    Qingdao,
    China

    Active - Recruiting

  • Changhai Hospital

    Shanghai,
    China

    Active - Recruiting

  • Huadong Hospital Affiliated to Fudan University

    Shanghai,
    China

    Active - Recruiting

  • Shanghai Changzheng Hospital

    Shanghai,
    China

    Active - Recruiting

  • Shanghai General Hospital

    Shanghai,
    China

    Active - Recruiting

  • Shanghai Sixth People&amp;#39;s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai,
    China

    Active - Recruiting

  • Tongji Hospital of Tongji University

    Shanghai,
    China

    Active - Recruiting

  • Huazhong University of Science and Technology Union Shenzhen Hospital

    Shenzhen,
    China

    Active - Recruiting

  • Shenzhen Shiyan People&amp;#39;s Hospital

    Shenzhen,
    China

    Active - Recruiting

  • The Seventh Affiliated Hospital of Sun Yat-sen University

    Shenzhen,
    China

    Active - Recruiting

  • Hebei Medical University Third Hospital

    Shijiazhuang,
    China

    Active - Recruiting

  • Kunshan Hospital of Traditional Chinese Medicine

    Suzhou,
    China

    Active - Recruiting

  • The First People&amp;#39;s Hospital of Kunshan

    Suzhou,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou,
    China

    Active - Recruiting

  • First Hospital of Shanxi Medical University

    Taiyuan,
    China

    Active - Recruiting

  • Second Hospital of Shanxi Medical University

    Taiyuan,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Urumqi,
    China

    Active - Recruiting

  • Weifang People&amp;#39;s Hospital

    Weifang,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou,
    China

    Active - Recruiting

  • Qinghai University Affiliated Hospital

    Xining,
    China

    Active - Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan,
    China

    Active - Recruiting

  • People&amp;#39;s Hospital of Ningxia Hui Autonomous Region

    Yinchuan,
    China

    Active - Recruiting

  • Henan Provincial General Hospital

    Zhengzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Active - Recruiting

  • The Fifth Affiliated Hospital Sun Yat-sen University

    Zhuhai,
    China

    Active - Recruiting

  • PKUCare Luzhong Hospital

    Zibo,
    China

    Active - Recruiting

  • Zibo Central Hospital

    Zibo,
    China

    Active - Recruiting

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