The Study will be conducted to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women with Osteoporosis.
The primary goal for the study is
1. To evaluate the efficacy of ENZ215 when compared to Prolia® in patients with postmenopausal osteoporosis, in terms of change in BMD at the lumbar spine from baseline to Month 12 and
2. To compare the AUEC of sCTX levels from baseline to Month 6
Who can participate
Age range55 Years – 85 Years
SexFEMALE
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Inclusion criteria
✓. Willing to provide voluntary written informed consent and able to comply with the protocol requirements
✓. Postmenopausal women aged ≥ 55 and ≤ 85 years globally, except for Spain. In Spain specifically refer to the below criteria:
✓. Postmenopausal women aged ≥ 75 and ≤ 85 years with LS T-score ≤ -2.5 or
Exclusion criteria
✕. In both cases (i.e. criteria a and b), it must also be that these are women who present a contraindication for the use of bisphosphonates or who do not tolerate the oral route.
✕. Body weight ≥ 50 kg and ≤ 90 kg
✕. Diagnosed with osteoporosis, with absolute BMD consistent with T-scores of ≤ 2.5 and ≥ - 4.0 at the lumbar spine (L1-L4 region) as measured by dual-energy X ray absorptiometry (DXA) at screening
✕. At least 5 years of postmenopausal status confirmed by follicle-stimulating hormone (FSH) levels at screening
✕. At least one hip joint and two vertebrae in L1-L4 region evaluable by DXA
✕. No other clinically significant medical history, vital signs, physical examination, laboratory profiles as deemed by the Investigator or designee that would pose a risk to participant safety or interfere with the study evaluation, procedures or completion
✕. Known hypersensitivity to denosumab or any of the excipients of the study drug
✕
What they're measuring
1
To Evaluate the Efficacy of ENZ215 When Compared to Prolia in Patients With Postmenopausal Osteoporosis, in Terms of Change in Bone Mineral Density (BMD) at Lumbar Spine.
Timeframe: Month 12
2
Area Under the Effect Curve (AUEC) of % Change From Baseline (%CfB) of Serum C-telopeptide of Type-1 Collagen (sCTX) Levels