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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 90 Years |
| Sex | All |
| Enrollment | 2478 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | denosumab, radiation, prednisone |
| Locations | 58 sites (Beijing and 57 other locations) |
| Status | Recruiting |
| Started | May 26, 2023 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT05866029 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 \>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 \<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 \> 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
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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
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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&#39;s Hospital
Changzhou, China Recruiting -
The First People&#39;s Hospital of Changzhou
Changzhou, China Recruiting -
Sichuan Provincial People's Hospital
Chengdu, China Recruiting -
West China Fourth Hospital of Sichuan University
Chengdu, China Recruiting -
The Second People&#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&#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&#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&#39;s Hospital
Liaocheng, China Recruiting -
Jiangxi Provincial People&#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&#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&#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&#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&#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
- Study coordinator: Weibo Xia
- Email: xiaweibo8301@163.com
- Phone: 13501002126
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Ibandronate vs. Zoledronic Acid After Denosumab: Is Either Equal for Postmenopausal Osteoporosis?
In postmenopausal osteoporosis, this study tests whether intravenous ibandronate given after stopping denosumab works as well as zoledronic acid over a year.
-
Romosozumab and denosumab alone or together for postmenopausal osteoporosis
This 6-month pilot tests whether cyclic romosozumab combined with denosumab improves bone density more than denosumab alone in postmenopausal women with osteoporosis.
-
Denosumab effects on muscle strength and insulin sensitivity
This trial will test whether denosumab improves muscle strength and insulin sensitivity in postmenopausal women with osteoporosis and type 2 diabetes who are taking metformin.
-
Combining PD-1 immunotherapy, denosumab, and chemotherapy for advanced non-squamous lung cancer without targetable mutations
This trial will test whether adding a PD-1 immunotherapy and denosumab to standard chemotherapy helps people with advanced non-squamous non-small cell lung cancer who do not have targetable driver mutations.
-
Using an osteoporotic fracture score to guide treatment for thoracic and lumbar spine fractures
This study will try using the OF (osteoporotic fracture) score to help doctors decide between surgery and non-surgical care for older adults with painful thoracic or lumbar osteoporotic fractures.
-
Comparing two treatment regimens for osteoporosis in postmenopausal women
This study is testing two different treatment plans for osteoporosis in postmenopausal women to see which one helps improve bone strength and reduce the risk of fractures better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.