Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
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)
1 other identifier
interventional
2,478
1 country
58
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2023
CompletedFirst Posted
Study publicly available on registry
May 19, 2023
CompletedStudy Start
First participant enrolled
May 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
January 12, 2026
December 1, 2025
3.4 years
April 28, 2023
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The main study：The incidence of new vertebral fractures
The main study：the incidence of new vertebral fractures (clinical and imaging) within 24 months of treatment
Within 24 months of treatment
The sub study：The rate of change in BMD from baseline at lumbar spine in 24 months
Within 24 months of treatment
Secondary Outcomes (10)
The main study：New vertebral fractures in 12 months
Within 12 months of treatment
The main study：New hip fractures, new fractures at other sites, and all new fractures at 12 and 24 months
Within 12 months and 24 months of treatment
The main study：The rate of BMD change from the baseline at the lumbar spine, total hip, and femoral neck in 12 and 24 months;
Within 12 months and 24 months of treatment
The main study：The rate of changes from baseline in serum type 1 collagen cross-linked C-terminal peptide (β-CTX) and type 1 procollagen N-terminal propeptide (P1NP) at 6, 12, and 24 months
6, 12, and 24 months
The main study：The patients' adherence to treatment
24 months
- +5 more secondary outcomes
Study Arms (2)
60mg of Denosumab treatment
ACTIVE COMPARATORMonotherapy with denosumab injection ( 60mg, subcutaneous injection, semi-annually) for 24 months.
Teriparatide was sequentially treated with Denosumab
EXPERIMENTAL1. Treatment with teriparatide injection ( 20ug, subcutaneous injection, once daily) for 6 months, followed by discontinuation of teriparatide and change to denosumab injection ( 60mg, subcutaneous injection, once every six months) and continued until the 24th month. 2. Treatment with teriparatide injection ( 20ug, subcutaneous injection, once daily) for 12 months, followed by discontinuation of teriparatide and change to denosumab injection ( 60mg, subcutaneous injection, semi-annually) treatment continued until the 24th month.
Interventions
Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
Teriparatide was sequentially treated with Denosumab
Eligibility Criteria
You may qualify if:
- New brittle hip fractures;
- New brittle vertebral fractures;
- New other site fractures and/or total hip or neck of femur or L1-L4 T-value \< -1.0;
- Men or postmenopausal women;
- Age 45-90 years old;
- Ability to move autonomously
You may not qualify if:
- bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia;
- Having primary hyperparathyroidism or hypothyroidism;
- Had or have osteomyelitis of the jaw or necrosis of the jaw;
- GFR\<30ml/min/1.73m2;
- Active infection that requires systematic treatment;
- Used intravenous bisphosphonate, fluoride, or strontium for osteoporosis within 2 years;
- Used teriparatide and denosumab for osteoporosis within 6 months;
- Used glucocorticoids (equivalent to \>5 mg/day prednisone) for more than 10 days within 6 weeks;
- 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) ;
- Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment;
- Have hypocalcemia and hypercalcemia;
- Unexplained elevation of alkaline phosphatase;
- A serious deficiency of vitamin D (25OHD \<10ng/mL);
- Patients who have previously received external radiation or radiation therapy with bone implants;
- Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin \> 8.5%, and severe arrhythmias;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
Beijing Pinggu Hospital
Beijing, China
Beijing Shijingshan Hospital
Beijing, China
Beijing Yanhua Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Jilin Province FAW General Hospital
Changchun, China
The Second XIANGYA Hospital of Central South University
Changsha, China
Changzhou NO.2 People&#39;s Hospital
Changzhou, China
The First People&#39;s Hospital of Changzhou
Changzhou, China
Sichuan Provincial People's Hospital
Chengdu, China
West China Fourth Hospital of Sichuan University
Chengdu, China
The Second People&#39;s Hospital of Dalian
Dalian, China
Shengli Oilfield Central Hospital
Dongying, China
Affiliated Hospital of Guizhou Medical University
Guiyang, China
Zhejiang Provincial People&#39;s Hospital Bijie Hospital
Guizhou, China
The Fourth Hospital of Harbin Medical University
Haerbin, China
The Second Hospital of Jilin University
Haerbin, China
Zhejiang Provincial People&#39;s Hospital
Hangzhou, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, China
Shandong Provincial Hospital
Jinan, China
The Second Hospital of Shandong University
Jinan, China
Affiliated Hospital of Jining Medical University
Jining, China
Gansu Provincial Hospital
Lanzhou, China
Liaocheng People&#39;s Hospital
Liaocheng, China
Jiangxi Provincial People&#39;s Hospital
Nanchang, China
Zhongda Hospital Southeast University
Nanjing, China
Ningbo NO.2 Hospital
Ningbo, China
Qingdao Municipal Hospital
Qingdao, China
Changhai Hospital
Shanghai, China
Huadong Hospital Affiliated to Fudan University
Shanghai, China
Shanghai Changzheng Hospital
Shanghai, China
Shanghai General Hospital
Shanghai, China
Shanghai Sixth People&#39;s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Tongji Hospital of Tongji University
Shanghai, China
Huazhong University of Science and Technology Union Shenzhen Hospital
Shenzhen, China
Shenzhen Shiyan People&#39;s Hospital
Shenzhen, China
The Seventh Affiliated Hospital of Sun Yat-sen University
Shenzhen, China
Hebei Medical University Third Hospital
Shijiazhuang, China
Kunshan Hospital of Traditional Chinese Medicine
Suzhou, China
The First People&#39;s Hospital of Kunshan
Suzhou, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
First Hospital of Shanxi Medical University
Taiyuan, China
Second Hospital of Shanxi Medical University
Taiyuan, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
Weifang People&#39;s Hospital
Weifang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Qinghai University Affiliated Hospital
Xining, China
General Hospital of Ningxia Medical University
Yinchuan, China
People&#39;s Hospital of Ningxia Hui Autonomous Region
Yinchuan, China
Henan Provincial General Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
The Fifth Affiliated Hospital Sun Yat-sen University
Zhuhai, China
PKUCare Luzhong Hospital
Zibo, China
Zibo Central Hospital
Zibo, China
Related Publications (1)
Chi Y, Zhu Y, Yuan J, Pang Q, Cui L, Jiang Y, Jiajue R, Liu W, Wang O, Li M, Xing X, Li H, Xie G, Wu Y, Xia W. 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 multicentre randomised controlled trial (STAND study) protocol. BMJ Open. 2026 Feb 26;16(2):e111364. doi: 10.1136/bmjopen-2025-111364.
PMID: 41748193DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Weibo Xia, MD.
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2023
First Posted
May 19, 2023
Study Start
May 26, 2023
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
January 12, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
Data related to this study will be made available upon reasonable request.