Clinical Efficacy and Safety of Teriparatide Combined with Jintiange Capsule in Patients with Low-Turnover Severe Osteoporosis and Very High Fracture Risk

INTERVENTION: experimental group:Teriparatide + Jintiange capsule;control group:Teriparatide + calcium carbonate; CONDITION: low‐turnover severe osteoporosis and very high fracture risk PRIMARY OUTCOME: Lumbar spine (L1–L4) bone mineral density (BMD); SECONDARY OUTCOME: Number of patients with incident fractures;Femoral neck bone mineral density (BMD);Other laboratory tests (including parathyroid hormone, serum calcium, serum phosphorus, serum vitamin D, complete blood count, liver function, renal function, and erythrocyte sedimentation rate);Incidence of serious adverse events (SAEs);Incidence of serious adverse events (SAEs);Bone turnover markers (serum total P1NP and ß‐CTX); INCLUSION CRITERIA: 1.Aged = 50 years (both males and females are eligible); females must be naturally postmenopausal for = 1 year. 2.Diagnosis of severe osteoporosis confirmed by dual‐energy X‐ray absorptiometry (DXA): bone mineral density (BMD) T‐score = ‐2.5 SD at the lumbar spine (L1–L4), femoral neck, or total hip, together with at least one fragility fracture (vertebral compression fracture confirmed by MRI or CT, or non‐traumatic hip fracture); or, patients without a history of fracture but with a BMD T‐score = ‐3.0 SD at the lumbar spine (L1–L4), femoral neck, or total hip. 3.Meeting the criteria for low‐turnover type: both serum total procollagen type I N‐terminal propeptide (P1NP) and beta‐C‐terminal telopeptide of type I collagen (ß‐CTX) are below the lower limit of the normal range (measured by electrochemiluminescence immunoassay on a Roche Cobas e601 analyzer). 4.Meeting the criteria for very high fracture risk: recent fragility fracture (especially within the