A randomized, double-blind, parallel-group, active-controlled comparative study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of LY06006 compared with EU-Prolia in postmenopausal women with osteoporosis

Conditions

Postmenopausal osteoporosis

Brief summary

Information is not publicly available

Detailed description

%CfB in lumbar spine BMD at Month 6, %CfB in total hip BMD at Months 6 and 12, %CfB in femoral neck BMD at Months 6 and 12, %CfB in sCTX at Months 0.5, 1, 2, 3, 6, 9, and 12, %CfB in sP1NP at Months 1, 6, and 12, AEs, including SAEs, Vital signs, Physical and dental examination, Clinical laboratory tests (hematology, clinical chemistry, and urinalysis), 12-lead ECG, Injection site reaction assessment, Serum drug concentrations at baseline and at Months 0.5, 1, 2, 3, 6, 9, and 12, Incidence of ADAs at baseline and at Months 0.5, 1, 2, 3, 6, 9, and 12, Incidence of NAbs at baseline and at Months 0.5, 1, 2, 3, 6, 9, and 12, %CfB (Month 12) in sCTX at Month 18, %CfB (Month 12) in sP1NP at Month 18, Serum drug concentrations at baseline (Month 12) and Months 15 and 18, Incidence of ADAs at baseline (Month 12), and Months 15 and 18, Incidence of NAbs at baseline (Month 12) and at Months 15 and 18

Related papers

No related papers found yet.

Interventions

DRUGProlia 60 mg solution for injection in pre-filled syringe

DRUGLY06006

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Information is not publicly available	—

Secondary

Measure	Time frame
%CfB in lumbar spine BMD at Month 6, %CfB in total hip BMD at Months 6 and 12, %CfB in femoral neck BMD at Months 6 and 12, %CfB in sCTX at Months 0.5, 1, 2, 3, 6, 9, and 12, %CfB in sP1NP at Months 1, 6, and 12, AEs, including SAEs, Vital signs, Physical and dental examination, Clinical laboratory tests (hematology, clinical chemistry, and urinalysis), 12-lead ECG, Injection site reaction assessment, Serum drug concentrations at baseline and at Months 0.5, 1, 2, 3, 6, 9, and 12, Incidence of ADAs at baseline and at Months 0.5, 1, 2, 3, 6, 9, and 12, Incidence of NAbs at baseline and at Months 0.5, 1, 2, 3, 6, 9, and 12, %CfB (Month 12) in sCTX at Month 18, %CfB (Month 12) in sP1NP at Month 18, Serum drug concentrations at baseline (Month 12) and Months 15 and 18, Incidence of ADAs at baseline (Month 12), and Months 15 and 18, Incidence of NAbs at baseline (Month 12) and at Months 15 and 18	—

Measure

Time frame

%CfB in lumbar spine BMD at Month 6, %CfB in total hip BMD at Months 6 and 12, %CfB in femoral neck BMD at Months 6 and 12, %CfB in sCTX at Months 0.5, 1, 2, 3, 6, 9, and 12, %CfB in sP1NP at Months 1, 6, and 12, AEs, including SAEs, Vital signs, Physical and dental examination, Clinical laboratory tests (hematology, clinical chemistry, and urinalysis), 12-lead ECG, Injection site reaction assessment, Serum drug concentrations at baseline and at Months 0.5, 1, 2, 3, 6, 9, and 12, Incidence of ADAs at baseline and at Months 0.5, 1, 2, 3, 6, 9, and 12, Incidence of NAbs at baseline and at Months 0.5, 1, 2, 3, 6, 9, and 12, %CfB (Month 12) in sCTX at Month 18, %CfB (Month 12) in sP1NP at Month 18, Serum drug concentrations at baseline (Month 12) and Months 15 and 18, Incidence of ADAs at baseline (Month 12), and Months 15 and 18, Incidence of NAbs at baseline (Month 12) and at Months 15 and 18

—

Countries

Bulgaria, Czechia, Poland

Outcome results

None listed