Clinical trial Recruiting at 58 sites Interventional Ages 45 to 90

Prevention and treatment of osteoporotic fractures

Official title: 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)

Run by Peking Union Medical College Hospital · NCT05866029 · Data updated 2026-11-12

This study is testing new ways to prevent and treat fractures in people with osteoporosis to see if they can improve care and outcomes.

More Osteoporotic Fractures trials

Quick facts

Study typeInterventional
Ages45 Years to 90 Years
SexAll
Enrollment2478 (estimated)
SponsorPeking Union Medical College Hospital
Academic / other
Drugs / interventionsdenosumab, radiation, prednisone
Locations58 sites (Beijing and 57 other locations)
StatusRecruiting
StartedMay 26, 2023
Main results expectedSeptember 30, 2026
Study endsSeptember 30, 2026
Registry record updatedJanuary 12, 2026
Trial IDNCT05866029 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men and postmenopausal women aged 45-90 with new brittle fractures.

Probably not a fit

Patients with other bone metabolic diseases or those who have recently used specific osteoporosis treatments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project focuses on osteoporotic fractures by conducting registration and follow-up studies to gather epidemiological data. It includes a prospective treatment study aimed at exploring effective treatment strategies through randomized controlled trials. The study also aims to establish a biomarker warning model using multi-omics research and develop a new imaging technology for creating an imaging omics warning model for osteoporotic refractures.

Why it matters

Potential benefit: If successful, this study could lead to improved prevention and treatment strategies for patients suffering from osteoporotic fractures.

How similar studies have gone: Other studies have shown success with similar approaches in managing osteoporotic fractures, indicating potential for this study's methodologies.

Who can join: the full rules

Show full inclusion / exclusion 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 \< -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

Where it's running

  • Beijing Friendship Hospital, Capital Medical University
    Beijing, China
    Recruiting
  • Beijing Hospital
    Beijing, China
    Recruiting
  • Beijing Pinggu Hospital
    Beijing, China
    Recruiting
  • Beijing Shijingshan Hospital
    Beijing, China
    Recruiting
  • Beijing Yanhua Hospital
    Beijing, China
    Recruiting
  • Peking Union Medical College Hospital
    Beijing, China
    Recruiting
Show 44 more locations
  • Peking University Third Hospital
    Beijing, China
    Recruiting
  • Jilin Province FAW General Hospital
    Changchun, China
    Recruiting
  • The Second XIANGYA Hospital of Central South University
    Changsha, China
    Recruiting
  • Changzhou NO.2 People&amp;#39;s Hospital
    Changzhou, China
    Recruiting
  • The First People&amp;#39;s Hospital of Changzhou
    Changzhou, China
    Recruiting
  • Sichuan Provincial People&#39;s Hospital
    Chengdu, China
    Recruiting
  • West China Fourth Hospital of Sichuan University
    Chengdu, China
    Recruiting
  • The Second People&amp;#39;s Hospital of Dalian
    Dalian, China
    Recruiting
  • Shengli Oilfield Central Hospital
    Dongying, China
    Recruiting
  • Affiliated Hospital of Guizhou Medical University
    Guiyang, China
    Recruiting
  • Zhejiang Provincial People&amp;#39;s Hospital Bijie Hospital
    Guizhou, China
    Recruiting
  • The Fourth Hospital of Harbin Medical University
    Haerbin, China
    Recruiting
  • The Second Hospital of Jilin University
    Haerbin, China
    Recruiting
  • Zhejiang Provincial People&amp;#39;s Hospital
    Hangzhou, China
    Recruiting
  • The First Affiliated Hospital of Anhui Medical University
    Hefei, China
    Recruiting
  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
    Hefei, China
    Recruiting
  • Affiliated Hospital of Inner Mongolia Medical University
    Hohhot, China
    Recruiting
  • Shandong Provincial Hospital
    Jinan, China
    Recruiting
  • The Second Hospital of Shandong University
    Jinan, China
    Recruiting
  • Affiliated Hospital of Jining Medical University
    Jining, China
    Recruiting
  • Gansu Provincial Hospital
    Lanzhou, China
    Recruiting
  • Liaocheng People&amp;#39;s Hospital
    Liaocheng, China
    Recruiting
  • Jiangxi Provincial People&amp;#39;s Hospital
    Nanchang, China
    Recruiting
  • Zhongda Hospital Southeast University
    Nanjing, China
    Recruiting
  • Ningbo NO.2 Hospital
    Ningbo, China
    Recruiting
  • Qingdao Municipal Hospital
    Qingdao, China
    Recruiting
  • Changhai Hospital
    Shanghai, China
    Recruiting
  • Huadong Hospital Affiliated to Fudan University
    Shanghai, China
    Recruiting
  • Shanghai Changzheng Hospital
    Shanghai, China
    Recruiting
  • Shanghai General Hospital
    Shanghai, China
    Recruiting
  • Shanghai Sixth People&amp;#39;s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, China
    Recruiting
  • Tongji Hospital of Tongji University
    Shanghai, China
    Recruiting
  • Huazhong University of Science and Technology Union Shenzhen Hospital
    Shenzhen, China
    Recruiting
  • Shenzhen Shiyan People&amp;#39;s Hospital
    Shenzhen, China
    Recruiting
  • The Seventh Affiliated Hospital of Sun Yat-sen University
    Shenzhen, China
    Recruiting
  • Hebei Medical University Third Hospital
    Shijiazhuang, China
    Recruiting
  • Kunshan Hospital of Traditional Chinese Medicine
    Suzhou, China
    Recruiting
  • The First People&amp;#39;s Hospital of Kunshan
    Suzhou, China
    Recruiting
  • The Second Affiliated Hospital of Soochow University
    Suzhou, China
    Recruiting
  • First Hospital of Shanxi Medical University
    Taiyuan, China
    Recruiting
  • Second Hospital of Shanxi Medical University
    Taiyuan, China
    Recruiting
  • The First Affiliated Hospital of Xinjiang Medical University
    Ürümqi, China
    Recruiting
  • Weifang People&amp;#39;s Hospital
    Weifang, China
    Recruiting
  • The Second Affiliated Hospital of Wenzhou Medical University
    Wenzhou, China
    Recruiting

+8 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.