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)

ClinicalTrials.gov Identifier: NCT03974100

Novartis Reference Number: CGP24112301

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a multicenter, randomized, parallel arm, double-blind study with a total duration up to 82 weeks. Approximately 522 postmenopausal patients with osteoporosis will be randomized at the beginning of Treatment Period 1 (Baseline to Week 52) to receive 2 doses of either GP2411 or EU-authorized Prolia.

At the beginning of Treatment Period 2 (Week 52 to Week 78) patients in Treatment Period 1 Prolia group will be re-randomized 1:1 to either continue with a third dose of EU- authorized Prolia, or transition to GP2411. All patients in the GP2411 group will continue the treatment with a third dose of GP2411.

Condition 
Postmenopausal Women With Osteoporosis
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
492 participants
Start date 
Jul 02, 2019
Completion date 
Jun 21, 2022
Gender 
Female
Age(s)
55 Years - 80 Years (Adult, Older Adult)

Interventions

Biological
GP2411
60 mg /mL subcutaneous injection every 6 months
Biological
EU authorized Prolia
60 mg /mL subcutaneous injection every 6 months

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

Other Inclusion/exclusion criteria may apply

Study Locations

United States
Sandoz Investigational Site
Recruiting
Peoria, 85381
Arizona
United States
Sandoz Investigational Site
Recruiting
San Diego, 92108
California
United States
Sandoz Investigational Site
Recruiting
Van Nuys, 91405
California
United States
Sandoz Investigational Site
Recruiting
Miami, 33135
Florida
United States
Sandoz Investigational Site
Recruiting
Tampa, 33614
Florida
United States
Sandoz Investigational Site
Recruiting
Wichita, 67207
Kansas
United States
Sandoz Investigational Site
Recruiting
Lexington, 40615
Kentucky
United States
Sandoz Investigational Site
Recruiting
Las Vegas, 89119
Nevada
United States
Sandoz Investigational Site
Recruiting
Berlin, 08009
New Jersey
United States
Sandoz Investigational Site
Recruiting
Charlotte, 28210
North Carolina
United States
Sandoz Investigational Site
Recruiting
Duncansville, 16635
Pennsylvania
United States
Sandoz Investigational Site
Recruiting
Wyomissing, 19610
Pennsylvania
United States
Sandoz Investigational Site
Recruiting
Spartanburg, 29303
South Carolina
United States
Sandoz Investigational Site
Recruiting
Carrollton, 75010
Texas
United States
Bulgaria
Sandoz Investigational Site
Recruiting
Plovdiv, 4001
-
Bulgaria
Sandoz Investigational Site
Recruiting
Plovdiv, 4002
-
Bulgaria
Sandoz Investigational Site
Recruiting
Sofia, 1431
-
Bulgaria
Sandoz Investigational Site
Recruiting
Sofia, 1505
-
Bulgaria
Sandoz Investigational Site
Recruiting
Sofia, 1680
-
Bulgaria
Sandoz Investigational Site
Recruiting
Sofia, 1784
-
Bulgaria
Czechia
Sandoz Investigational Site
Recruiting
Ostrava, 772 00
Czech Republic
Czechia
Sandoz Investigational Site
Recruiting
Hradec Kralove, 500 05
CZE
Czechia
Sandoz Investigational Site
Recruiting
Brno, 602 00
-
Czechia
Sandoz Investigational Site
Recruiting
Ostrava, 702 00
-
Czechia
Sandoz Investigational Site
Recruiting
Pardubice, 530 02
-
Czechia
Sandoz Investigational Site
Recruiting
Plzen, 30460
-
Czechia
Sandoz Investigational Site
Recruiting
Praha 11, 148 00
-
Czechia
Sandoz Investigational Site
Recruiting
Praha 2, 128 50
-
Czechia
Sandoz Investigational Site
Recruiting
Uherske Hradiste, 686 01
-
Czechia
Sandoz Investigational Site
Recruiting
Zlin, 760 01
-
Czechia
Japan
Sandoz Investigational Site
Recruiting
Fujimi, 354-0021
Saitama
Japan
Sandoz Investigational Site
Recruiting
Hachioji-city, 192-0046
Tokyo
Japan
Sandoz Investigational Site
Recruiting
Kiyose-city, 204-0021
Tokyo
Japan
Sandoz Investigational Site
Recruiting
Minato-ku, 108-0075
Tokyo
Japan
Sandoz Investigational Site
Recruiting
Shinagawa, 140-0014
Tokyo
Japan
Poland
Sandoz Investigational Site
Recruiting
Krakow, 30-510
Malopolskie
Poland
Sandoz Investigational Site
Recruiting
Bialystok, 15-351
-
Poland
Sandoz Investigational Site
Recruiting
Bialystok, 15-461
-
Poland
Sandoz Investigational Site
Recruiting
Bydgoszcz, 85 168
-
Poland
Sandoz Investigational Site
Recruiting
Lodz, 90 242
-
Poland
Sandoz Investigational Site
Recruiting
Nadarzyn, 05-830
-
Poland
Sandoz Investigational Site
Recruiting
Torun, 87-100
-
Poland
Sandoz Investigational Site
Recruiting
Warszawa, 00-874
-
Poland
Sandoz Investigational Site
Recruiting
Warszawa, 02 118
-
Poland
Sandoz Investigational Site
Recruiting
Warszawa, 02 691
-
Poland
Spain
Sandoz Investigational Site
Recruiting
Santiago de Compostela, 15705
A Coruna
Spain
Sandoz Investigational Site
Recruiting
Sabadell, 08208
Barcelona
Spain
Sandoz Investigational Site
Recruiting
Barcelona, 08003
Catalunya
Spain
Sandoz Investigational Site
Recruiting
Santiago de Compostela, 15706
Galicia
Spain
Sandoz Investigational Site
Recruiting
Barcelona, 08041
-
Spain
Sandoz Investigational Site
Recruiting
Granada, 18012
-
Spain
Sandoz Investigational Site
Recruiting
Madrid, 28009
-
Spain
Sandoz Investigational Site
Recruiting
Sevilla, 41010
-
Spain

Contacts

Name: 
Sandoz
Phone: 
Name: 
Sandoz
Phone: 
Email: 

Have a question?

Call 1-888-669-6682 or email [email protected]