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NCT05866029Recruiting

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)

Source: ClinicalTrials.gov · Last updated 12 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
2478 (estimated)
First submitted
28 Apr 2023
Start date
26 May 2023
Primary completion date
30 Sept 2026
Lead sponsor
Peking Union Medical College Hospital
Diseases
Osteoporosis
NCT number
NCT05866029

What you commit to

  • Study type: Interventional
  • Planned participants: 2478
  • From 26 May 2023 to the primary completion date, 30 Sept 2026
  • 58 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have previously received external radiation or radiation therapy with bone implants;
  • Participating in clinical trials of other drugs at present;

Other illness

  • bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia;
  • Active infection that requires systematic treatment;
  • Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment;
  • Allergic to teriparatide and denosumab;

Lab values

  • GFR\<30ml/min/1.73m2;
  • Unexplained elevation of alkaline phosphatase;
  • Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin \&gt; 8.5%, and severe arrhythmias;

Other

  • Having primary hyperparathyroidism or hypothyroidism;
  • Had or have osteomyelitis of the jaw or necrosis of the jaw;
  • Used intravenous bisphosphonate, fluoride, or strontium for osteoporosis within 2 years;
  • 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) ;
  • Have hypocalcemia and hypercalcemia;
  • A serious deficiency of vitamin D (25OHD \&lt;10ng/mL);
  • Planned pregnancy and lactation at present or during the study period;
  • subjects do not suitable for this study

Who the study is looking for

  • 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 \&lt; -1.0;
  • Men or postmenopausal women;
  • Age 45-90 years old;
  • Ability to move autonomously

Age in the registry: 45 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (58)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaRecruiting
Beijing Shijingshan Hospital
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BeijingChinaRecruiting
Beijing Yanhua Hospital
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BeijingChinaRecruiting
Beijing Pinggu Hospital
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BeijingChinaRecruiting
Peking Union Medical College Hospital
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BeijingChinaRecruiting
Peking University Third Hospital
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BeijingChinaRecruiting
Beijing Hospital
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BeijingChinaRecruiting
Jilin Province FAW General Hospital
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ChangchunChinaRecruiting
The Second Xiangya Hospital of Central South University
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ChangshaChinaRecruiting
Changzhou NO.2 People&amp;#39;s Hospital
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ChangzhouChinaRecruiting
The First People&amp;#39;s Hospital of Changzhou
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ChangzhouChinaRecruiting
West China Fourth Hospital of Sichuan University
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ChengduChinaRecruiting
Sichuan Provincial People&#39;s Hospital
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ChengduChinaRecruiting
The Second People&amp;#39;s Hospital of Dalian
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DalianChinaRecruiting
Shengli Oilfield Central Hospital
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DongyingChinaRecruiting
Affiliated Hospital of Guizhou Medical University
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GuiyangChinaRecruiting
Zhejiang Provincial People&amp;#39;s Hospital Bijie Hospital
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GuizhouChinaRecruiting
The Second Hospital of Jilin University
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HaerbinChinaRecruiting
The Fourth Hospital of Harbin Medical University
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HaerbinChinaRecruiting
Zhejiang Provincial People&amp;#39;s Hospital
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HangzhouChinaRecruiting
The First Affiliated Hospital of USTC(Anhui Provincial Hospital)
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HefeiChinaRecruiting
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaRecruiting
Affiliated Hospital of Inner Mongolia Medical University
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HohhotChinaRecruiting
Shandong Provincial Hospital
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JinanChinaRecruiting
The Second Hospital of Shandong University
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JinanChinaRecruiting
Affiliated Hospital of Jining Medical University
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JiningChinaRecruiting
Gansu Provincial Hospital
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LanzhouChinaRecruiting
Liaocheng People&amp;#39;s Hospital
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LiaochengChinaRecruiting
Jiangxi Provincial People&amp;#39;s Hospital
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NanchangChinaRecruiting
Zhongda Hospital Southeast University
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NanjingChinaRecruiting
Ningbo No.2 Hospital
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NingboChinaRecruiting
QingDao Municipal Hospital
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QingdaoChinaRecruiting
Tongji Hospital of Tongji University
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ShanghaiChinaRecruiting
Changhai Hospital
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ShanghaiChinaRecruiting
Huadong Hospital Affiliated to Fudan University
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ShanghaiChinaRecruiting
Shanghai General Hospital
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ShanghaiChinaRecruiting
Shanghai Sixth People&amp;#39;s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaRecruiting
Shanghai Changzheng Hospital
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ShanghaiChinaRecruiting
The Seventh Affiliated Hospital of Sun Yat-sen University
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ShenzhenChinaRecruiting
Huazhong University of Science and Technology Union Shenzhen Hospital
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ShenzhenChinaRecruiting
Shenzhen Shiyan People&amp;#39;s Hospital
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ShenzhenChinaRecruiting
Hebei medical university third hospital
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ShijiazhuangChinaRecruiting
The First People&amp;#39;s Hospital of Kunshan
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SuzhouChinaRecruiting
The Second Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
Kunshan Hospital of Traditional Chinese Medicine
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SuzhouChinaRecruiting
Second hospital of Shanxi Medical University
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TaiyuanChinaRecruiting
First Hospital of Shanxi Medical University
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TaiyuanChinaRecruiting
The First Affiliated Hospital of Xinjiang Medical University
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ÜrümqiChinaRecruiting
Weifang People&amp;#39;s Hospital
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WeifangChinaRecruiting
The Second Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
Qinghai university affiliated hospital
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XiningChinaRecruiting
People&amp;#39;s Hospital of Ningxia Hui Autonomous Region
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YinchuanChinaRecruiting
General Hospital of Ningxia Medical University
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YinchuanChinaRecruiting
Henan Provincial General Hospital
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ZhengzhouChinaRecruiting
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaRecruiting
The Fifth Affiliated Hospital Sun Yat-sen University
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ZhuhaiChinaRecruiting
PKUCare Luzhong Hospital
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ZiboChinaRecruiting
Zibo Central hospital
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ZiboChinaRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.