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

June 21, 2022 updated by: Sandoz

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

527

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • Sandoz Investigational Site
      • Plovdiv, Bulgaria, 4002
        • Sandoz Investigational Site
      • Sofia, Bulgaria, 1431
        • Sandoz Investigational Site
      • Sofia, Bulgaria, 1505
        • Sandoz Investigational Site
      • Sofia, Bulgaria, 1680
        • Sandoz Investigational Site
      • Sofia, Bulgaria, 1784
        • Sandoz Investigational Site
  • Czechia
      • Brno, Czechia, 602 00
        • Sandoz Investigational Site
      • Ostrava, Czechia, 702 00
        • Sandoz Investigational Site
      • Pardubice, Czechia, 530 02
        • Sandoz Investigational Site
      • Plzen, Czechia, 30460
        • Sandoz Investigational Site
      • Praha 11, Czechia, 148 00
        • Sandoz Investigational Site
      • Praha 2, Czechia, 128 50
        • Sandoz Investigational Site
      • Uherske Hradiste, Czechia, 686 01
        • Sandoz Investigational Site
    • CZE
      • Hradec Kralove, CZE, Czechia, 500 05
        • Sandoz Investigational Site
    • Czech Republic
      • Ostrava, Czech Republic, Czechia, 772 00
        • Sandoz Investigational Site
  • Japan
    • Saitama
      • Fujimi, Saitama, Japan, 354-0021
        • Sandoz Investigational Site
    • Tokyo
      • Chuoh-ku, Tokyo, Japan, 104-0031
        • Sandoz Investigational Site
      • Hachioji-city, Tokyo, Japan, 192-0046
        • Sandoz Investigational Site
      • Kiyose-city, Tokyo, Japan, 204-0021
        • Sandoz Investigational Site
      • Shinagawa, Tokyo, Japan, 140-0014
        • Sandoz Investigational Site
  • Poland
      • Bialystok, Poland, 15-351
        • Sandoz Investigational Site
      • Bialystok, Poland, 15-461
        • Sandoz Investigational Site
      • Bydgoszcz, Poland, 85 168
        • Sandoz Investigational Site
      • Lodz, Poland, 90 242
        • Sandoz Investigational Site
      • Nadarzyn, Poland, 05-830
        • Sandoz Investigational Site
      • Torun, Poland, 87-100
        • Sandoz Investigational Site
      • Warszawa, Poland, 00-874
        • Sandoz Investigational Site
      • Warszawa, Poland, 02 118
        • Sandoz Investigational Site
      • Warszawa, Poland, 02 691
        • Sandoz Investigational Site
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-510
        • Sandoz Investigational Site
  • Spain
      • Barcelona, Spain, 08041
        • Sandoz Investigational Site
      • Madrid, Spain, 28009
        • Sandoz Investigational Site
      • Sevilla, Spain, 41010
        • Sandoz Investigational Site
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15705
        • Sandoz Investigational Site
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Sandoz Investigational Site
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15706
        • Sandoz Investigational Site
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Sandoz Investigational Site
    • Florida
      • Miami, Florida, United States, 33135
        • Sandoz Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Sandoz Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Sandoz Investigational Site
      • Wyomissing, Pennsylvania, United States, 19610
        • Sandoz Investigational Site
    • Texas
      • Carrollton, Texas, United States, 75010
        • Sandoz Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GP2411
60 mg /mL subcutaneous injection every 6 months
Biological: GP2411
60 mg /mL subcutaneous injection every 6 months
Active Comparator: EU authorized Prolia
60 mg /mL subcutaneous injection every 6 months
Biological: EU authorized Prolia
60 mg /mL subcutaneous injection every 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from baseline (%CfB) in lumbar spine Bone Mineral Density
Time Frame: Baseline, Week 52
Treatment Period 1
Baseline, Week 52
Area under the effect versus time curve (AUEC) after first dose, percent change from baseline in serum Collagen C-telopeptide (CTX)
Time Frame: Baseline, Week 52
Treatment Period 1
Baseline, Week 52
Serum PK parameter AUCinf after first dose
Time Frame: Baseline, Week 52
Treatment Period 1
Baseline, Week 52
Serum PK parameter Cmax after first dose
Time Frame: Baseline, Week 52
Treatment Period 1
Baseline, Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from baseline in Bone Mineral Density at femoral neck and total hip by DXA
Time Frame: Baseline, Week 52
Treatment Period 1
Baseline, Week 52
CTX serum concentration
Time Frame: Baseline, Week 52
Treatment Period 1
Baseline, Week 52
Occurence of adverse events and serious adverse events
Time Frame: Screening, Week 52
Treatment Period 1
Screening, Week 52
Anti-drug antibodies (ADAs) serum concentration
Time Frame: Baseline, Week 52
Treatment Period 1
Baseline, Week 52
Percent change from baseline of Bone Mineral density at lumbar spine, femoral neck and total hip by DXA
Time Frame: Week 52, Week 78
Treatment Period 2
Week 52, Week 78
CTX serum concentration
Time Frame: Week 52, week 78
Treatment Period 2
Week 52, week 78
Adverse events and serious adverse events
Time Frame: Week 52, Week 78
Treatment Period 2
Week 52, Week 78
Procollagen 1 N-terminal propeptide (P1NP) serum concentration
Time Frame: Week 52, Week 78
Treatment Period 2
Week 52, Week 78
P1NP serum concentration
Time Frame: Baseline, Week 52
Treatment Period 1
Baseline, Week 52
Antidrug antibodies (ADAs) serum concentration
Time Frame: Week 52, Week 78
Treatment Period 2
Week 52, Week 78

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Collaborators

Hexal AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2019

Primary Completion (Actual)

April 22, 2022

Study Completion (Actual)

April 22, 2022

Study Registration Dates

First Submitted

June 3, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGP24112301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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