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

The main study：The incidence of new vertebral fractures

Time frame · 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

Time frame · Within 24 months of treatment

The main study：New vertebral fractures in 12 months

Time frame · 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

Time frame · 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;

Time frame · Within 12 months and 24 months of treatment

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

Time frame · 6, 12, and 24 months

The main study：The patients' adherence to treatment

Time frame · 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 main study：Cost-effectiveness

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.

The sub study：BMD change at lumbar spine in 12 months

Time frame · Within 12 months of treatment

The sub study：BMD changes at total hip and femoral neck in 12 and 24 months

Time frame · Within 12 months and 24 months of treatment

The sub study：Serum β-CTX and P1NP levels at 12 and 24 months

Time frame · 12 months and 24 months

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

Time frame · Within 12 months and 24 months of treatment