Phase 3
N=479
A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
Postmenopausal Women With Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT04757376 ↗Enrolled (actual)
479
Serious AEs
3.1%
Results posted
May 2024
Primary outcome: Primary: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 - Full Analysis Set (FAS) — 4.9597; 5.1528 percentage change (%)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CT-P41 (Biological); US-licensed Prolia (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- Celltrion
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 - Full Analysis Set (FAS) |
4.9597; 5.1528 | — |
| SECONDARY Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 52 - FAS |
5.4913; 5.6621; 2.7914; 2.4253; 2.2295; 1.9476 | — |
| SECONDARY Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 78 - FAS-TP II Subset |
6.8588; 6.5745; 7.0532; 3.4706; 2.7947; 3.3837 | — |
| SECONDARY Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP I - FAS |
1; 1; 2; 4; 0; 0 | — |
| SECONDARY Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP II - FAS-TP II Subset |
1; 0; 0; 2; 0; 1 | — |
| SECONDARY Trough Serum Concentration (Ctrough) of Denosumab at Weeks 0 and 26 - Pharmacokinetic (PK) Set |
46.79; 31.69; 75.64; 63.99 | — |
| SECONDARY Ctrough of Denosumab at Week 52 - PK-TP II Subset |
70.24; 66.60; 126.15 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of Denosumab After First Dose - PK Set |
5851.2; 5492.7 | — |
| SECONDARY Percent Change From Baseline for Serum Concentration of Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Weeks 26 and 52 - Pharmacodynamic (PD) Set |
-75.6972; -74.3547; -72.7506; -72.5275 | — |
| SECONDARY Percent Change From Baseline for Serum Concentration of s-CTX at Week 78 - PD-TP II Subset |
-70.4609; -64.9063; -70.1268 | — |
| SECONDARY Percent Change From Baseline for Serum Concentration of Procollagen Type 1 N-terminal Propeptide (P1NP) at Weeks 26 and 52 - PD Set |
-69.31; -68.22; -69.99; -66.61 | — |
| SECONDARY Percent Change From Baseline for Serum Concentration of P1NP at Week 78 - PD-TP II Subset |
-67.05; -68.60; -64.54 | — |
| SECONDARY Number of Participants With at Least 1 Anti-drug Antibodies (ADA)/Neutralizing Antibodies (NAb) Result After the First Study Drug Administration of TP I - Safety Set |
233; 234; 0; 0 | — |
| SECONDARY Number of Participants With at Least 1 ADA/NAb Result After the First Study Drug Administration of TP II - Safety-TP II Subset |
208; 92; 93; 0; 0; 0 | — |
Summary
This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis
Eligibility Criteria
Inclusion Criteria
- Women, 50 to 80 years of age, both inclusive.
- Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
- Postmenopausal
- Bone mineral density T-score ≤ - 2.5 and ≥ - 4.0 at the lumbar spine (L1 to L4) as assessed by the central imaging vendor based on dual-energy X-ray absorptiometry(DXA) scan.
- Patients must have at least 3 vertebrae considered evaluable at the lumbar spine (L1 to L4) and at least 1 hip considered evaluable by DXA scan assessed by the central imaging vendor. Patients with unilateral metal in hips that would be allowed for the other side of 1 evaluable hip are included.
- Patient with albumin-adjusted total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) at Screening.
Exclusion Criteria
- Patient previously received denosumab, any other monoclonal antibodies, or biologic agents for osteoporosis
- Patient confirmed or suspected with infection of COVID-19 at Screening, or has contact with COVID-19 patient within 14 days from Screening
- Patient with history and/or presence of one severe or > 2 moderate vertebral fractures as determined by central reading of lateral spine X-ray
- Patient with history and/or presence of hip fracture
- Patient with history and/or presence of hyperparathyroidism or hypoparathyroidism, irrespective of current controlled or uncontrolled status
- Patient with current hyperthyroidism (unless well controlled on stable antithyroid therapy)
- Patient with current hypothyroidism (unless well controlled on stable thyroid replacement therapy)
- Patient with history and/or presence of bone disease and metabolic disease (except for osteoporosis) that may interfere with the interpretation of the results
Data sourced from ClinicalTrials.gov (NCT04757376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.