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.
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
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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 \> 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 \>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 \<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 \< -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
Helyszínek (58)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | Kína | Toboroz |
| Beijing Shijingshan Hospital | Beijing | Kína | Toboroz |
| Beijing Yanhua Hospital | Beijing | Kína | Toboroz |
| Beijing Pinggu Hospital | Beijing | Kína | Toboroz |
| Peking Union Medical College Hospital | Beijing | Kína | Toboroz |
| Peking University Third Hospital | Beijing | Kína | Toboroz |
| Beijing Hospital | Beijing | Kína | Toboroz |
| Jilin Province FAW General Hospital | Changchun | Kína | Toboroz |
| The Second Xiangya Hospital of Central South University | Changsha | Kína | Toboroz |
| Changzhou NO.2 People&#39;s Hospital | Changzhou | Kína | Toboroz |
| The First People&#39;s Hospital of Changzhou | Changzhou | Kína | Toboroz |
| West China Fourth Hospital of Sichuan University | Chengdu | Kína | Toboroz |
| Sichuan Provincial People's Hospital | Chengdu | Kína | Toboroz |
| The Second People&#39;s Hospital of Dalian | Dalian | Kína | Toboroz |
| Shengli Oilfield Central Hospital | Dongying | Kína | Toboroz |
| Affiliated Hospital of Guizhou Medical University | Guiyang | Kína | Toboroz |
| Zhejiang Provincial People&#39;s Hospital Bijie Hospital | Guizhou | Kína | Toboroz |
| The Second Hospital of Jilin University | Haerbin | Kína | Toboroz |
| The Fourth Hospital of Harbin Medical University | Haerbin | Kína | Toboroz |
| Zhejiang Provincial People&#39;s Hospital | Hangzhou | Kína | Toboroz |
| The First Affiliated Hospital of USTC(Anhui Provincial Hospital) | Hefei | Kína | Toboroz |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Kína | Toboroz |
| Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Kína | Toboroz |
| Shandong Provincial Hospital | Jinan | Kína | Toboroz |
| The Second Hospital of Shandong University | Jinan | Kína | Toboroz |
| Affiliated Hospital of Jining Medical University | Jining | Kína | Toboroz |
| Gansu Provincial Hospital | Lanzhou | Kína | Toboroz |
| Liaocheng People&#39;s Hospital | Liaocheng | Kína | Toboroz |
| Jiangxi Provincial People&#39;s Hospital | Nanchang | Kína | Toboroz |
| Zhongda Hospital Southeast University | Nanjing | Kína | Toboroz |
| Ningbo No.2 Hospital | Ningbo | Kína | Toboroz |
| QingDao Municipal Hospital | Qingdao | Kína | Toboroz |
| Tongji Hospital of Tongji University | Shanghai | Kína | Toboroz |
| Changhai Hospital | Shanghai | Kína | Toboroz |
| Huadong Hospital Affiliated to Fudan University | Shanghai | Kína | Toboroz |
| Shanghai General Hospital | Shanghai | Kína | Toboroz |
| Shanghai Sixth People&#39;s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Kína | Toboroz |
| Shanghai Changzheng Hospital | Shanghai | Kína | Toboroz |
| The Seventh Affiliated Hospital of Sun Yat-sen University | Shenzhen | Kína | Toboroz |
| Huazhong University of Science and Technology Union Shenzhen Hospital | Shenzhen | Kína | Toboroz |
| Shenzhen Shiyan People&#39;s Hospital | Shenzhen | Kína | Toboroz |
| Hebei medical university third hospital | Shijiazhuang | Kína | Toboroz |
| The First People&#39;s Hospital of Kunshan | Suzhou | Kína | Toboroz |
| The Second Affiliated Hospital of Soochow University | Suzhou | Kína | Toboroz |
| Kunshan Hospital of Traditional Chinese Medicine | Suzhou | Kína | Toboroz |
| Second hospital of Shanxi Medical University | Taiyuan | Kína | Toboroz |
| First Hospital of Shanxi Medical University | Taiyuan | Kína | Toboroz |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Kína | Toboroz |
| Weifang People&#39;s Hospital | Weifang | Kína | Toboroz |
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Kína | Toboroz |
| Qinghai university affiliated hospital | Xining | Kína | Toboroz |
| People&#39;s Hospital of Ningxia Hui Autonomous Region | Yinchuan | Kína | Toboroz |
| General Hospital of Ningxia Medical University | Yinchuan | Kína | Toboroz |
| Henan Provincial General Hospital | Zhengzhou | Kína | Toboroz |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Kína | Toboroz |
| The Fifth Affiliated Hospital Sun Yat-sen University | Zhuhai | Kína | Toboroz |
| PKUCare Luzhong Hospital | Zibo | Kína | Toboroz |
| Zibo Central hospital | Zibo | Kína | Toboroz |
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