AzTrials
AzTrials

Osteoporotic FracturesNCT05866029

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

A study testing Denosumab and Teriparatide in people with Osteoporotic Fractures, run by Peking Union Medical College Hospital at 58 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 45 to 90 years
Conditions the study is for
Osteoporotic Fractures
What is being tested?
Denosumab and Teriparatide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,478 participants
Where
58 sitesChina
Study dates
26 May 2023to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 19Show fewer
  • Used teriparatide and denosumab for osteoporosis within 6 months;
  • Used glucocorticoids (equivalent to \&gt;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 \&lt;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 \&gt; 8.5%, and severe arrhythmias;
  • Planned pregnancy and lactation at present or during the study period;
  • Allergic to teriparatide and denosumab;
  • Participating in clinical trials of other drugs at present;
  • subjects do not suitable for this study

Trial locations and contacts

58 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Weibo Xia contact

13501002126

xiaweibo8301@163.com

58 sites in 1 country

China58 sites, 58 recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

    Hai Tang, 13601362187, tanghai@ccmu.edu.cn

    Recruiting

  • Beijing Hospital

    Beijing

    Liangyuan Wen, 13911901100, wenliangyuan1964@126.com

    Recruiting

  • Beijing Pinggu Hospital

    Beijing

    Yufeng Li, 13911080328, doctorlyf@126.com

    Recruiting

  • Beijing Shijingshan Hospital

    Beijing

    Shichun Li, 13701016395, lishichun.2008@163.com

    Recruiting

  • Beijing Yanhua Hospital

    Beijing

    Lin Qi, 13381137318, qilin1964@163.com

    Recruiting

  • Peking Union Medical College Hospital

    Beijing

    Weibo Xia, 13501002126, xiaweibo8301@163.com

    Recruiting

  • Peking University Third Hospital

    Beijing

    Chunli Song, 13901009038, schl@bjmu.edu.cn

    Recruiting

  • Jilin Province FAW General Hospital

    Changchun

    Mengmeng Zhang, 13844825866, zhmm5866@163.com

    Recruiting

  • The Second XIANGYA Hospital of Central South University

    Changsha

    Zhongjian Xie, 17308479573, zhongjian.xie@csu.edu.cn

    Recruiting

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

    Changzhou

    Jinluo Cheng, 13685258866, chengjinluo567@sina.com

    Recruiting

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

    Changzhou

    Xiaohong Jiang, 13912343611, jxh0400@163.com

    Recruiting

  • Sichuan Provincial People&#39;s Hospital

    Chengdu

    Lei Zhang, 18981838308, 1632147793@qq.com

    Recruiting

  • West China Fourth Hospital of Sichuan University

    Chengdu

    Jian Xu, 13408419025, 29511177@qq.com

    Recruiting

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

    Dalian

    Yun Ci, 13332269501, Ciyuan69@163.com

    Recruiting

  • Shengli Oilfield Central Hospital

    Dongying

    Lulu Wang, 18678698276, oawang@126.com

    Recruiting

  • Affiliated Hospital of Guizhou Medical University

    Guiyang

    Nianchun Peng, 18685136019, pnch2001@126.com

    Recruiting

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

    Guizhou

    Jun Zhang, 13868140717, spinezhangjun@aliyun.com

    Recruiting

  • The Fourth Hospital of Harbin Medical University

    Haerbin

    Zhifeng Cheng, 18903602198, hydsynfm1@163.com

    Recruiting

  • The Second Hospital of Jilin University

    Haerbin

    Yanguo Qin, 13904315668, qinyg@jlu.edu.cn

    Recruiting

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

    Hangzhou

    Qifeng Ying, 13958070122, yqf2013@aliyun.com

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

    Fang Dai, 13965053243, dfang1999@163.com

    Recruiting

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

    Hefei

    Chao Chen, 18963788827, chenchao9007@sohu.com

    Recruiting

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot

    Zhaoli Yan, 13848177245, 475715548@qq.com

    Recruiting

  • Shandong Provincial Hospital

    Jinan

    Jin Xu, 13869113268, xujin267903@163.com

    Recruiting

  • The Second Hospital of Shandong University

    Jinan

    Shihong Chen, 17660080807, chengshihong26@163.com

    Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining

    Bo Ban, 18678760007, banbo2011@163.com

    Recruiting

  • Gansu Provincial Hospital

    Lanzhou

    Qi Zhang, 13679479918, lzzq78@126.com

    Recruiting

  • Liaocheng People&amp;#39;s Hospital

    Liaocheng

    Jie, Bai, 13346258761, baijiebnm@163.com

    Recruiting

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

    Nanchang

    Yanan Huo, 13970029871, 13970029871@126.com

    Recruiting

  • Zhongda Hospital Southeast University

    Nanjing

    Yunfeng Rui, 13705182577, ruiyunfeng@126.com

    Recruiting

  • Ningbo NO.2 Hospital

    Ningbo

    Jinping Fei, 13586793626, fjpnb76@126.com

    Recruiting

  • Qingdao Municipal Hospital

    Qingdao

    Qiang Li, 13792870264, qdslliqiang@163.com

    Recruiting

  • Changhai Hospital

    Shanghai

    Jie Gao, 13585561861, Gaojif@qq.com

    Recruiting

  • Huadong Hospital Affiliated to Fudan University

    Shanghai

    Qun Cheng, 13918336748, chengqun@fudan.edu.cn

    Recruiting

  • Shanghai Changzheng Hospital

    Shanghai

    Jiaoyang Zheng, 13918508688, 13918508688@163.com

    Recruiting

  • Shanghai General Hospital

    Shanghai

    Li You, 13501684367, youlisky2002@126.com

    Recruiting

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

    Shanghai

    Hua Yue MD, 18930172517, yueyinglonghua@163.com

    Recruiting

  • Tongji Hospital of Tongji University

    Shanghai

    Keqin Zhang, 13621798084, keqzhang2007@126.com

    Recruiting

  • Huazhong University of Science and Technology Union Shenzhen Hospital

    Shenzhen

    Dazhi Yang, 13670064780, 371272891@qq.com

    Recruiting

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

    Shenzhen

    Mingshan Mi, 18297007198, mmsqh0971@163.com

    Recruiting

  • The Seventh Affiliated Hospital of Sun Yat-sen University

    Shenzhen

    Fangping Li, 13929751968, 472655037@qq.com

    Recruiting

  • Hebei Medical University Third Hospital

    Shijiazhuang

    JIanxia Ma, 13315169756, 809967567@qq.com

    Recruiting

  • Kunshan Hospital of Traditional Chinese Medicine

    Suzhou

    Yong Chen, 13405664488, carlacj@163.com

    Recruiting

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

    Suzhou

    Huiqing Shan, 13962423432, hawkshan@126.com

    Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou

    Youjia Xu, 13013870777, xuyoujia@suda.edu.cn

    Recruiting

  • First Hospital of Shanxi Medical University

    Taiyuan

    Fei Gao, 13935110660, 13935110660@126.com

    Recruiting

  • Second Hospital of Shanxi Medical University

    Taiyuan

    Yikun Zhu, 13835166087, zyk1003@126.com

    Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi

    Li Luo, 13999868690, luoli.6@163.com

    Recruiting

  • Weifang People&amp;#39;s Hospital

    Weifang

    Xuecheng Sun, 15853637565, 15883637565@163.com

    Recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou

    Xiangyang Wang, 13506663458, kkjinhaiming@126.com

    Recruiting

  • Qinghai University Affiliated Hospital

    Xining

    Jianwen Ma, 18909715055, 18909715055@189.cn

    Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan

    Chen Lei, 13995100693, 1175719190@qq.com

    Recruiting

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

    Yinchuan

    Lijun Cai, 13995113139, Lijun-cai1801@163.com

    Recruiting

  • Henan Provincial General Hospital

    Zhengzhou

    Huijuan Yuan, 13513891997, hjyuan@zzu.edu.cn

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Hongjian Liu, 13700886128, hongjianmd@126.com

    Recruiting

  • The Fifth Affiliated Hospital Sun Yat-sen University

    Zhuhai

    Xiaochun Shu, 13326601313, zhshuxc@163.com

    Recruiting

  • PKUCare Luzhong Hospital

    Zibo

    Qun Liu, 18553376569, 596923216@qq.com

    Recruiting

  • Zibo Central Hospital

    Zibo

    Xiaodong Zhao, 18678186512, yy3731080c@163.com

    Recruiting

Other trials in China

About this study

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)

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.

Being tested
Denosumab, Teriparatide
Keywords
osteoporosis, osteoporotic fractures, bone turnover markers, imaging biomarkers
Medical subject headings
Osteoporotic Fractures, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DenosumabDrug

    Active Comparator: 60mg of Denosumab treatment by subcutaneous injection

  • TeriparatideDrug

    Teriparatide was sequentially treated with Denosumab

Study groups in NCT05866029
Study groupRoleWhat they receive
60mg of Denosumab treatmentActive comparatorMonotherapy with denosumab injection ( 60mg, subcutaneous injection, semi-annually) for 24 months.
Receives: Drug: Denosumab
Teriparatide was sequentially treated with DenosumabExperimental1. 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.
Receives: Drug: Denosumab; Drug: Teriparatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Within 24 months of treatment

  2. The sub study：The rate of change in BMD from baseline at lumbar spine in 24 months

    Measured: Within 24 months of treatment

Secondary outcomes (10)

  1. The main study：New vertebral fractures in 12 months

    Measured: Within 12 months of treatment

  2. The main study：New hip fractures, new fractures at other sites, and all new fractures at 12 and 24 months

    Measured: Within 12 months and 24 months of treatment

  3. 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;

    Measured: Within 12 months and 24 months of treatment

  4. 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

    Measured: 6, 12, and 24 months

  5. The main study：The patients' adherence to treatment

    Non-adherence rate=Number of patients non-adherencet with teriparatide or denosumab / Total number of patients.

    1. Denosumab Adherence Adherence to denosumab treatment was assessed based on protocol compliance during the study period. Non-adherence was defined as one or more instances in which the scheduled denosumab injection was not administered according to the study protocol, including doses received outside the permissible treatment window (±4 weeks).
    2. Teriparatide Adherence Adherence to teriparatide was evaluated only in the two sequential treatment groups assigned to receive teriparatide. Using patient diary records, non-adherence was defined as an actual-to-expected injection day ratio of less than 80% or greater than 120% over the course of the study period.

    Measured: 24 months

  6. The main study：Cost-effectiveness

    The incremental cost-effectiveness ratio is defined as the average additional drug cost required per additional fracture event avoided in the intervention group compared to the control group.

    Measured: 24 months

  7. The sub study：BMD change at lumbar spine in 12 months

    Measured: Within 12 months of treatment

  8. The sub study：BMD changes at total hip and femoral neck in 12 and 24 months

    Measured: Within 12 months and 24 months of treatment

  9. The sub study：Serum β-CTX and P1NP levels at 12 and 24 months

    Measured: 12 months and 24 months

  10. The sub study：The incidence of new vertebral fractures, hip fractures, new fractures at other sites, and all new fractures in 12 and 24 months

    Measured: Within 12 months and 24 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2023
  2. Study start26 May 2023
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
2,478 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05866029
Sponsor's protocol ID
2022-PUMCH-D-006
Status last verified
Dec 2025
First submitted
28 Apr 2023
Last updated
12 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data related to this study will be made available upon reasonable request.

Publications

  • 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.

    PubMed 41748193

Questions about this trial

What is this clinical trial studying?

A study testing Denosumab and Teriparatide in people with Osteoporotic Fractures, run by Peking Union Medical College Hospital at 58 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Weibo Xia (13501002126, xiaweibo8301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The main study：The incidence of new vertebral fractures (time frame: Within 24 months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05866029, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in