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NCT05866029Toboroz

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)

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jan. 12.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
2478 (tervezett)
Első benyújtás
2023. ápr. 28.
Kezdés
2023. máj. 26.
Elsődleges befejezés
2026. szept. 30.
Fő szponzor
Peking Union Medical College Hospital
Betegségek
Csontritkulás
NCT-szám
NCT05866029

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 2478
  • 2023. máj. 26. és az elsődleges befejezés (2026. szept. 30.) között
  • 58 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Korábbi kezelés

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

Más betegség

  • 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;

Laborértékek

  • 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;

Egyéb

  • 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

Kiket keres a vizsgálat

  • 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

Életkor a regiszterben: 45 év – 90 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (58)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Beijing Friendship Hospital, Capital Medical UniversityBeijingKínaToboroz
Beijing Shijingshan HospitalBeijingKínaToboroz
Beijing Yanhua HospitalBeijingKínaToboroz
Beijing Pinggu HospitalBeijingKínaToboroz
Peking Union Medical College HospitalBeijingKínaToboroz
Peking University Third HospitalBeijingKínaToboroz
Beijing HospitalBeijingKínaToboroz
Jilin Province FAW General HospitalChangchunKínaToboroz
The Second Xiangya Hospital of Central South UniversityChangshaKínaToboroz
Changzhou NO.2 People&amp;#39;s HospitalChangzhouKínaToboroz
The First People&amp;#39;s Hospital of ChangzhouChangzhouKínaToboroz
West China Fourth Hospital of Sichuan UniversityChengduKínaToboroz
Sichuan Provincial People&#39;s HospitalChengduKínaToboroz
The Second People&amp;#39;s Hospital of DalianDalianKínaToboroz
Shengli Oilfield Central HospitalDongyingKínaToboroz
Affiliated Hospital of Guizhou Medical UniversityGuiyangKínaToboroz
Zhejiang Provincial People&amp;#39;s Hospital Bijie HospitalGuizhouKínaToboroz
The Second Hospital of Jilin UniversityHaerbinKínaToboroz
The Fourth Hospital of Harbin Medical UniversityHaerbinKínaToboroz
Zhejiang Provincial People&amp;#39;s HospitalHangzhouKínaToboroz
The First Affiliated Hospital of USTC(Anhui Provincial Hospital)HefeiKínaToboroz
The First Affiliated Hospital of Anhui Medical UniversityHefeiKínaToboroz
Affiliated Hospital of Inner Mongolia Medical UniversityHohhotKínaToboroz
Shandong Provincial HospitalJinanKínaToboroz
The Second Hospital of Shandong UniversityJinanKínaToboroz
Affiliated Hospital of Jining Medical UniversityJiningKínaToboroz
Gansu Provincial HospitalLanzhouKínaToboroz
Liaocheng People&amp;#39;s HospitalLiaochengKínaToboroz
Jiangxi Provincial People&amp;#39;s HospitalNanchangKínaToboroz
Zhongda Hospital Southeast UniversityNanjingKínaToboroz
Ningbo No.2 HospitalNingboKínaToboroz
QingDao Municipal HospitalQingdaoKínaToboroz
Tongji Hospital of Tongji UniversityShanghaiKínaToboroz
Changhai HospitalShanghaiKínaToboroz
Huadong Hospital Affiliated to Fudan UniversityShanghaiKínaToboroz
Shanghai General HospitalShanghaiKínaToboroz
Shanghai Sixth People&amp;#39;s Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghaiKínaToboroz
Shanghai Changzheng HospitalShanghaiKínaToboroz
The Seventh Affiliated Hospital of Sun Yat-sen UniversityShenzhenKínaToboroz
Huazhong University of Science and Technology Union Shenzhen HospitalShenzhenKínaToboroz
Shenzhen Shiyan People&amp;#39;s HospitalShenzhenKínaToboroz
Hebei medical university third hospitalShijiazhuangKínaToboroz
The First People&amp;#39;s Hospital of KunshanSuzhouKínaToboroz
The Second Affiliated Hospital of Soochow UniversitySuzhouKínaToboroz
Kunshan Hospital of Traditional Chinese MedicineSuzhouKínaToboroz
Second hospital of Shanxi Medical UniversityTaiyuanKínaToboroz
First Hospital of Shanxi Medical UniversityTaiyuanKínaToboroz
The First Affiliated Hospital of Xinjiang Medical UniversityÜrümqiKínaToboroz
Weifang People&amp;#39;s HospitalWeifangKínaToboroz
The Second Affiliated Hospital of Wenzhou Medical UniversityWenzhouKínaToboroz
Qinghai university affiliated hospitalXiningKínaToboroz
People&amp;#39;s Hospital of Ningxia Hui Autonomous RegionYinchuanKínaToboroz
General Hospital of Ningxia Medical UniversityYinchuanKínaToboroz
Henan Provincial General HospitalZhengzhouKínaToboroz
The First Affiliated Hospital of Zhengzhou UniversityZhengzhouKínaToboroz
The Fifth Affiliated Hospital Sun Yat-sen UniversityZhuhaiKínaToboroz
PKUCare Luzhong HospitalZiboKínaToboroz
Zibo Central hospitalZiboKínaToboroz

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