postmenopausal osteoporosis
Conditions
Interventions
Arm 1: Main Period: LY06006, Transition Period: LY06006.
Arm 2: Main Period: EU Prolia, Transition Period: LY06006 / EU Prolia
Sponsors
Dong Ying
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Participant must sign an ICF, which includes compliance with the requirements and restrictions in the protocol. 2. Ambulatory postmenopausal woman at >= 60 to = -4.0 at the lumbar spine (L1-L4 region) as measured by DXA. 4. Has at least two lumbar vertebrae in L1 L4 region and one hip evaluable by DXA for BMD measurement. 5. Body weight >= 50 kg and <= 90 kg
Exclusion criteria
Exclusion criteria: 1. A history and/or presence of severe or more than two moderate vertebral fractures; or a history and/or presence of hip fracture or atypical femur fracture; or presence of any active healing fracture 2. BMD absolute value is consistent with a T-score = 2 X ULN) 6. Severe renal disease (eGFR 3 years cumulatively at Screening visit; 2) oral bisphosphonates at any dose used within 1 year prior to Screening visit (if = 5 mg prednisone or equivalent per day for more than 10 days or cumulative >= 50 mg) within 3 months prior to Screening visit - Other bone active drugs such as anticonvulsants, heparin, vitamin K etc. within 3 months prior to Screening visit 9. A history and/or presence of significant cardiac disease or ECG abnormalities, or other clinically significant medical conditions indicating significant risk for participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - %CfB in lumbar spine BMD at Month 12 | — |
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 | — |
Countries
Bulgaria, Czech Republic, Japan, Poland, USA
Contacts
Public ContactChikako Rosario
Parexel International Inc.
Outcome results
None listed