Osteoporotic Fractures
Conditions
Keywords
osteoporosis, osteoporotic fractures, bone turnover markers, imaging biomarkers
Brief 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.
Interventions
DRUGDenosumab
Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
DRUGTeriparatide
Teriparatide was sequentially treated with Denosumab
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. New brittle hip fractures; 2. New brittle vertebral fractures; 3. New other site fractures and/or total hip or neck of femur or L1-L4 T-value < -1.0; 4. Men or postmenopausal women; 5. Age 45-90 years old; 6. Ability to move autonomously
Exclusion criteria
1. bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia; 2. Having primary hyperparathyroidism or hypothyroidism; 3. Had or have osteomyelitis of the jaw or necrosis of the jaw; 4. GFR\<30ml/min/1.73m2; 5. Active infection that requires systematic treatment; 6. Used intravenous bisphosphonate, fluoride, or strontium for osteoporosis within 2 years; 7. Used teriparatide and denosumab for osteoporosis within 6 months; 8. Used glucocorticoids (equivalent to >5 mg/day prednisone) for more than 10 days within 6 weeks; 9. 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) ; 10. Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment; 11. Have hypocalcemia and hypercalcemia; 12. Unexplained elevation of alkaline phosphatase; 13. A serious deficiency of vitamin D (25OHD <10ng/mL); 14. Patients who have previously received external radiation or radiation therapy with bone implants; 15. Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin > 8.5%, and severe arrhythmias; 16. Planned pregnancy and lactation at present or during the study period; 17. Allergic to teriparatide and denosumab; 18. Participating in clinical trials of other drugs at present; 19. subjects do not suitable for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The main study：The incidence of new vertebral fractures | Within 24 months of treatment | 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 | Within 24 months of treatment | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The sub study：BMD changes at total hip and femoral neck in 12 and 24 months | Within 12 months and 24 months of treatment | — |
| The sub study：Serum β-CTX and P1NP levels at 12 and 24 months | 12 months and 24 months | — |
| The main study：New vertebral fractures in 12 months | 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 | Within 12 months and 24 months of treatment | — |
| The main study：Cost-effectiveness | 24 months | The incremental cost-effectiveness ratio is defined as the average additional drug cost required per additional fracture event avoided in the intervention group compared to the control group. |
| 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 | 6, 12, and 24 months | — |
| The main study：The patients' adherence to treatment | 24 months | Non-adherence rate=Number of patients non-adherencet with teriparatide or denosumab / Total number of patients. 1. Denosumab Adherence Adherence to denosumab treatment was assessed based on protocol compliance during the study period. Non-adherence was defined as one or more instances in which the scheduled denosumab injection was not administered according to the study protocol, including doses received outside the permissible treatment window (±4 weeks). 2. Teriparatide Adherence Adherence to teriparatide was evaluated only in the two sequential treatment groups assigned to receive teriparatide. Using patient diary records, non-adherence was defined as an actual-to-expected injection day ratio of less than 80% or greater than 120% over the course of the study period. |
| 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 | 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; | Within 12 months and 24 months of treatment | — |
| The sub study：BMD change at lumbar spine in 12 months | Within 12 months of treatment | — |
Countries
China
Contacts
Primary ContactWeibo Xia
Outcome results
None listed