About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Denosumab
DrugActive Comparator: 60mg of Denosumab treatment by subcutaneous injection
Teriparatide
DrugTeriparatide was sequentially treated with Denosumab
Treatment groups
Trial outcomes
Primary outcomes
The main study:The incidence of new vertebral fractures
The main study:the incidence of new vertebral fractures (clinical and imaging) within 24 months of treatment
The sub study:The rate of change in BMD from baseline at lumbar spine in 24 months
Secondary outcomes
The main study:New vertebral fractures in 12 months
The main study:New hip fractures, new fractures at other sites, and all new fractures at 12 and 24 months
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;
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
Sponsors and contacts
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