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

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат Denosumab
  Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
• Препарат Teriparatide
  Teriparatide was sequentially treated with Denosumab

Первичные конечные точки

• The main study：The incidence of new vertebral fractures [Срок оценки: Within 24 months of treatment]
• The sub study：The rate of change in BMD from baseline at lumbar spine in 24 months [Срок оценки: Within 24 months of treatment]

Вторичные конечные точки (10)

• The main study：New vertebral fractures in 12 months [Срок оценки: 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 [Срок оценки: 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; [Срок оценки: 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 [Срок оценки: 6, 12, and 24 months]
• The main study：The patients' adherence to treatment [Срок оценки: 24 months]
• The main study：Cost-effectiveness [Срок оценки: 24 months]
• The sub study：BMD change at lumbar spine in 12 months [Срок оценки: Within 12 months of treatment]
• The sub study：BMD changes at total hip and femoral neck in 12 and 24 months [Срок оценки: Within 12 months and 24 months of treatment]
• The sub study：Serum β-CTX and P1NP levels at 12 and 24 months [Срок оценки: 12 months and 24 months]
• 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 [Срок оценки: Within 12 months and 24 months of treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 \&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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 58 центров

• Beijing Friendship Hospital, Capital Medical University — Пекин
• Beijing Hospital — Пекин
• Beijing Pinggu Hospital — Пекин
• Beijing Shijingshan Hospital — Пекин
• Beijing Yanhua Hospital — Пекин
• Peking Union Medical College Hospital — Пекин
• Peking University Third Hospital — Пекин
• Jilin Province FAW General Hospital — Changchun
• … и ещё 50 центров

Публикации

• 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: 10.11 PMID 41748193

Идентификаторы

NCT: NCT05866029 · 2022-PUMCH-D-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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