A real-word study of biosimilar denosumab (Rukexin)

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Denosumab originator treatment group (Prolia):None;Non‐pharmacist intervention group:No intervention;Denosumab biosimilar treatment group (Rukexin):None;Pharmacist intervention group:Pharmacist intervention; CONDITION: Postmenopausal women with osteoporosis PRIMARY OUTCOME: Change rate in bone mineral density (BMD) of lumbar spine at 12 months;Proportion of patients with adherence to denosumab at 6 months; SECONDARY OUTCOME: Change rate in BMD of lumbar spine at 6 months;Change rate in BMD of femoral neck at 6 months and 12 months;Proportion of willing to continue receiving pharmacist intervention at 12 months;Quality of life scores reported by chinese osteoporosis‐targeted quality of life questionnaire (COQOL) at 6 months and 12 months;Recognition of denosumab injection scored on a 5‐point Likert scale at 6 months and 12 months;Recognition of lifestyle intervention scored on a 5‐point Likert scale at 6 months and 12 months;Days of drug coverage (PDC) of calcium supplements at 6 and 12 months;Incidence of new hip fractures within 12 months;Quality of life scores reported by EQ‐5D‐5L at 6 months and 12 months;Proportion of patients with persistence to denosumab for 6 months;Time to second injection;Medical cost of related osteoporosis within 12 months;Treatment cost of anti‐osteoporosis within 12 months;Incidence of new fractures within 12 months;Medical cost of direct fracture within 12 months;Recognition of continuous medication for basic treatment scored on a 5‐point Likert scale at 6 months and 12 months;Incidence of new vertebral fractures within 12 months;Change rate in bone turnover markers (BTMs) at 6 months and 12 months;Recognition of regular denosumab injection scored on a 5‐point Likert scale at 6 months and 12 months;Recognition of basic treatment scored on a 5‐point Likert scale at 6 months and 12 months;Number of denosumab injections within 12 months;Days of drug coverage (PDC) of vitamin D at 6 and 12 months; INCLUSION CRITERIA: Part 1: 1.Aged >= 55 years; 2.Postmenopausal women, defined as spontaneous amenorrhea > 2 years or surgical bilateral oophorectomy > 2 years. 3.Meet one of the following three criteria: a) bone mineral density (BMD) T‐Score < ‐2.5 at vertebral, hip or femoral as measured by quantitative computed tomography (QCT) or dual‐energy x‐ray absorptiometry (DXA). b) fragility fractures of hip or vertebral. c) ‐2.5 < T‐Score <‐1.0, and complicates with fragility fractures of proximal humerus, pelvis or distal forearm. 4.Patients are first treated with denosumab of originator drug (Prolia) and biosimilar (Rukexin), and within no more than 7 days before enroll. 5.Voluntarily participates in the part 1 study, and signs appropriate informed consent. Part 2: Patients in part 1 must meet all of the following INCLUSION CRITERIA: 1. Have basic reading and understanding ability, and the education level of primary school or above. 2. Mobile communicat
Epistemonikos ID: 220449d585afefd3fefebbf1db5ebbeef15e4fbf
First added on: Oct 08, 2026