Denosumab
DrugActive Comparator: 60mg of Denosumab treatment by subcutaneous injection
NCT Number: NCT05866029
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.
Interested in participating?
Request Info45 year–90 year
All sexes
Interventional
Not applicable
Beijing Friendship Hospital, Capital Medical University, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
Teriparatide was sequentially treated with Denosumab
Time frame: Within 24 months of treatment
The main study:the incidence of new vertebral fractures (clinical and imaging) within 24 months of treatment
Time frame: Within 24 months of treatment
Time frame: Within 12 months of treatment
Time frame: Within 12 months and 24 months of treatment
Time frame: Within 12 months and 24 months of treatment
Time frame: 6, 12, and 24 months
Time frame: 24 months
Non-adherence rate=Number of patients non-adherencet with teriparatide or denosumab / Total number of patients.
Time frame: 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.
Time frame: Within 12 months of treatment
Time frame: Within 12 months and 24 months of treatment
Time frame: 12 months and 24 months
Time frame: Within 12 months and 24 months of treatment
Contact information is provided by the study sponsor or research team.
Peking Union Medical College Hospital
Other
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)
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