Study investigating PK, PD, efficacy, safety, and immunogenicity of biosimilar denosumab (GP2411) in patients with postmenopausal osteoporosis.

A randomized, double-blind, multicenter integrated phase I/III study in postmenopausal women with osteoporosis to compare the pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity of GP2411 (proposed biosimilar denosumab) and Prolia (EU-authorized).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224911

Enrollment

Registered

2019-10-11

Start date

2019-12-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Osteoporosis

Interventions

investigational material(s) Generic name etc : GP2411 ( proposed biosimilar denosumab) INN of investigational material : Denosumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: -Postmenopausal women, diagnosed with osteoporosis -Aged >_ 55 and __ 50 kg 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

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 Other Inclusion/exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
efficacy pharmacokinetics pharmacodynamics Treatment Period(Day 1-Week 52) - Percent change from baseline (%CfB) in lumbar spine BMD (LS-BMD) at Week 52 AUEC after first dose, of %CfB in serum CTX - Serum PK parameters AUCinf and Cmax after first dos	—

Secondary

Measure	Time frame
safety pharmacokinetics pharmacodynamics other Treatment Period 2 (Week 52 - Week 78) - %CfB in LS-BMD, FN-BMD, TH-BMD at Week 78 - PD markers: CTX and PINP serum concentrations as per visit schedule from Week 52 up to Week 78 - Safety: fractures, vital signs, laboratory safety assessments, injection site reactions, ECG, occurrence of AEs and serious AEs from Week 52 up to Week 78 - Immunogenicity: Development of binding and neutralizing anti-drug antibodies (ADAs) from Week 52 up to Week 78 - Denosumab serum concentrations as per visit schedule from Week 52 up to Week 78	—

Measure

Time frame

safety pharmacokinetics pharmacodynamics other Treatment Period 2 (Week 52 - Week 78) - %CfB in LS-BMD, FN-BMD, TH-BMD at Week 78 - PD markers: CTX and PINP serum concentrations as per visit schedule from Week 52 up to Week 78 - Safety: fractures, vital signs, laboratory safety assessments, injection site reactions, ECG, occurrence of AEs and serious AEs from Week 52 up to Week 78 - Immunogenicity: Development of binding and neutralizing anti-drug antibodies (ADAs) from Week 52 up to Week 78 - Denosumab serum concentrations as per visit schedule from Week 52 up to Week 78

—

Countries

Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026