Phase 3
Completed N=527
Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis
Postmenopausal Women With Osteoporosis
Source: ClinicalTrials.gov NCT03974100 ↗
Enrolled (actual)
527
Serious AEs
2.5%
Results posted
Mar 2023
Primary outcomePrimary: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52 - Per-Protocol Set — 4.955; 5.099 Percentage change (%)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52 - Per-Protocol Set |
4.955; 5.099 | — |
| PRIMARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52 - TP1 Full Analysis Set |
4.963; 5.140 | — |
| PRIMARY Area Under the Effect-time Curve (AUEC) of Percentage Change From Baseline in Serum CTX Concentrations After First Dose - Pharmacodynamic Analysis Set |
15700; 15900 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax) of Denosumab After First Dose |
6970; 7050 | — |
| PRIMARY Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) of Denosumab After First Dose |
370000; 365000 | — |
| SECONDARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 26 - Treatment Period 1 (Per-Protocol Set) |
3.6501; 3.6700 | — |
| SECONDARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 26 - Treatment Period 1 (TP1 Full Analysis Set) |
3.5877; 3.7144 | — |
| SECONDARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 78 - Treatment Period 2 (TP2 Full Analysis Set) |
6.8222; 7.0694; 6.4212 | — |
| SECONDARY Percent Change From Baseline in Femoral Neck Bone Mineral Density (FN-BMD) at Week 26 and Week 52 - Treatment Period 1 (Per-Protocol Set) |
2.0818; 1.8087; 2.4200; 2.6157 | — |
| SECONDARY Percent Change From Baseline in Femoral Neck Bone Mineral Density (FN-BMD) at Week 26 and Week 52 - Treatment Period 1 (TP1 Full Analysis Set) |
2.0343; 1.8210; 2.3686; 2.5717 | — |
| SECONDARY Percent Change From Baseline in Femoral Neck Bone Mineral Density (FN-BMD) at Week 78 - Treatment Period 2 (TP2 Full Analysis Set) |
3.2220; 2.9406; 2.6857 | — |
| SECONDARY Percent Change From Baseline in Total Hip Bone Mineral Density (TH-BMD) at Week 26 and Week 52 - Treatment Period 1 (Per-Protocol Set) |
2.6475; 2.1178; 3.4289; 3.3211 | — |
| SECONDARY Percent Change From Baseline in Total Hip Bone Mineral Density (TH-BMD) at Week 26 and Week 52 - Treatment Period 1 (TP1 Full Analysis Set) |
2.5280; 2.0595; 3.2882; 3.2234 | — |
| SECONDARY Percent Change From Baseline in Total Hip Bone Mineral Density (TH-BMD) at Week 78 - Treatment Period 2 (TP2 Full Analysis Set) |
3.8270; 4.0898; 3.9987 | — |
| SECONDARY CTX Serum Concentrations as Per Visit Schedule up to Week 52 - Treatment Period 1 |
0.437; 0.450; 0.0904; 0.0859; 0.0383; 0.0407 | — |
| SECONDARY CTX Serum Concentrations as Per Visit Schedule From Week 52 up to Week 78 - Treatment Period 2 |
0.0335; 0.0358; 0.0330; 0.0335; 0.0352; 0.0359 | — |
| SECONDARY PINP Serum Concentrations as Per Visit Schedule up to Week 52 - Treatment Period 1 |
60.3; 62.2; 58.5; 60.2; 56.8; 58.8 | — |
| SECONDARY PINP Serum Concentrations as Per Visit Schedule From Week 52 up to Week 78 - Treatment Period 2 |
13.7; 13.9; 14.4; 10.5; 10.9; 11.1 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs up to Week 52 - Treatment Period 1 |
157; 181; 36; 49; 12; 8 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs From Week 52 up to Week 78 - Treatment Period 2 |
68; 47; 48; 7; 7; 5 | — |
| SECONDARY Number of Participants With Vertebral Fractures up to Week 52 - Treatment Period 1 |
123; 116; 15; 24; 3; 3 | — |
| SECONDARY Number of Participants With Vertebral Fractures From Week 52 up to Week 78 - Treatment Period 2 |
126; 57; 65; 12; 3; 8 | — |
| SECONDARY Number of Participants With Nonvertebral Fractures up to Week 52 - Treatment Period 1 |
2; 0; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants With Nonvertebral Fractures From Week 52 up to Week 78 - Treatment Period 2 |
1; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Injection Site Reactions (ISRs) up to Week 52 - Treatment Period 1 |
6; 9; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Injection Site Reactions (ISRs) From Week 52 up to Week 78 - Treatment Period 2 |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADA) up to Week 52 - Treatment Period 1 |
93; 108; 7; 4; 86; 104 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADA) From Week 52 up to Week 78 - Treatment Period 2 |
42; 26; 26; 3; 3; 0 | — |
| SECONDARY Denosumab Serum Concentrations as Per Visit Schedule up to Week 52 - Treatment Period 1 |
0.00; 0.928; 4930; 5250; 6820; 6890 | — |
| SECONDARY Denosumab Serum Concentrations as Per Visit Schedule From Week 52 up to Week 78 - Treatment Period 2 |
6010; 5550; 6220; 1540; 1330; 1640 | — |
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women, diagnosed with osteoporosis
- Aged ≥ 55 and ≤ 80 years at screening
- Body weight ≥ 50 kg and ≤ 90 kg at screening
- Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar spine as measured by DXA
- At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA
Exclusion Criteria
- Previous exposure to denosumab (Prolia, Xgeva, or biosimilar denosumab)
- History and/or presence of one severe or more than two moderate vertebral fractures or hip fracture
- History and/or presence of bone metastases, bone disease or metabolic disease
- Ongoing use of any osteoporosis treatment or use of prohibited treatment
- Other bone active drugs
- History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or hypercalcemia
Data sourced from ClinicalTrials.gov (NCT03974100). 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. Informational only — not medical advice.