Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

Sandoz

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Women With Osteoporosis

Treatments: Biological: GP2411; Biological: EU-Prolia (EU-authorized Prolia®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03974100

2018-003523-11 (EudraCT Number)

CGP24112301

Details and patient eligibility

About

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).

Full description

This was an international, multicenter, randomized, double-blind, parallel-group study with a total duration of up to 83 weeks.

The study comprised a screening period of up to 5 weeks to assess a subject's eligibility and two treatment periods: Treatment Period 1 (TP1) from Day 1 to Week 52 and Treatment Period 2 (TP2) from Week 52 to Week 78.

Women with postmenopausal osteoporosis (PMO) were randomized on Day 1 in a 1:1 ratio to receive either two 60 mg subcutaneous (s.c.) doses at 26-week intervals of GP2411 (proposed biosimilar denosumab) or EU-Prolia (EU-authorized Prolia®) during TP1. At Week 52, participants in the EU-Prolia group were re-randomized 1:1 to either continue with a third dose of EU-Prolia or switch to GP2411 for TP2. Participants in the GP2411 group continued the treatment with a third dose of GP2411 in TP2. The End of Study was achieved at Week 78.

Enrollment: 527 patients

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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527 participants in 2 patient groups

GP2411

Experimental group

Description:

60 mg /mL subcutaneous injection every 6 months

Treatment:

Biological: GP2411

EU authorized Prolia

Active Comparator group

Description:

60 mg /mL subcutaneous injection every 6 months

Treatment:

Biological: EU-Prolia (EU-authorized Prolia®)