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)
Peking Union Medical College Hospital
2,478 participants
May 26, 2023
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria6
- 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
Exclusion Criteria19
- 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 \>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 \<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 \> 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
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Interventions
Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
Teriparatide was sequentially treated with Denosumab
Locations(58)
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NCT05866029