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

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoporotic Fractures

Intervention / Treatment
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* Drug: Denosumab
* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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; The time gap between the first time and the last time oral bisphosphonate for osteoporosis less than 1 year; 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 60mg of Denosumab treatment<br> | Drug: Denosumab<br>* Active Comparator: 60mg of Denosumab treatment by subcutaneous injection<br>|
| Experimental: Teriparatide was sequentially treated with Denosumab<br> | Drug: Denosumab<br>* Active Comparator: 60mg of Denosumab treatment by subcutaneous injection<br>Drug: Teriparatide<br>* Teriparatide was sequentially treated with Denosumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of new vertebral fractures | The incidence of new vertebral fractures (clinical and imaging) within 24 months of treatment | Within 24 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, osteoporotic fractures, bone turnover markers, imaging biomarkers