Prevention and treatment of osteoporotic fractures

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)

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2478 (estimated)
• Ages: 45 Years to 90 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: denosumab, radiation, prednisone
• Locations: 58 sites (Beijing and 57 other locations)
• Trial ID: NCT05866029 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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

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 \< -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 this trial is running

Beijing and 57 other locations

• 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)
• 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's Hospital — Changzhou, China (Recruiting)
• The First People'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'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'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'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's Hospital — Liaocheng, China (Recruiting)
• Jiangxi Provincial People'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'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'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'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's Hospital — Weifang, China (Recruiting)
• The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, China (Recruiting)

Study contacts

• Study coordinator: Weibo Xia

Conditions Osteoporotic Fractures; osteoporosis; osteoporotic fractures; bone turnover markers; imaging biomarkers