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

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ClinicalTrials.gov Identifier: NCT03974100
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Hexal AG
Information provided by (Responsible Party):
Sandoz

Brief Summary:

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 or disease Intervention/treatment Phase
Postmenopausal Women With Osteoporosis Biological: GP2411 Biological: EU authorized Prolia Phase 3

Expanded Access : Sandoz has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 522 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: double blind
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : July 2, 2019
Estimated Primary Completion Date : December 28, 2021
Estimated Study Completion Date : July 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Denosumab

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




Primary Outcome Measures :
  1. Percent change from baseline (%CfB) in lumbar spine Bone Mineral Density [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1

  2. 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

  3. Serum PK parameter AUCinf after first dose [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1

  4. Serum PK parameter Cmax after first dose [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1


Secondary Outcome Measures :
  1. Percent change from baseline in Bone Mineral Density at femoral neck and total hip by DXA [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1

  2. CTX serum concentration [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1

  3. Occurence of adverse events and serious adverse events [ Time Frame: Screening, Week 52 ]
    Treatment Period 1

  4. Anti-drug antibodies (ADAs) serum concentration [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1

  5. 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

  6. CTX serum concentration [ Time Frame: Week 52, week 78 ]
    Treatment Period 2

  7. Adverse events and serious adverse events [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2

  8. Procollagen 1 N-terminal propeptide (P1NP) serum concentration [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2

  9. P1NP serum concentration [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1

  10. Antidrug antibodies (ADAs) serum concentration [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2



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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postmenopausal women, diagnosed with osteoporosis
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974100


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, California
Novartis Investigative Site Recruiting
Van Nuys, California, United States, 91405
United States, Florida
Novartis Investigative Site Recruiting
Miami, Florida, United States, 33135
United States, Kansas
Novartis Investigative Site Recruiting
Wichita, Kansas, United States, 67207
United States, Kentucky
Novartis Investigative Site Recruiting
Lexington, Kentucky, United States, 40615
United States, Nevada
Novartis Investigative Site Recruiting
Las Vegas, Nevada, United States, 89119
United States, Pennsylvania
Novartis Investigative Site Recruiting
Duncansville, Pennsylvania, United States, 16635
Novartis Investigative Site Recruiting
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Novartis Investigative Site Recruiting
Spartanburg, South Carolina, United States, 29303
United States, Texas
Novartis Investigative Site Recruiting
Carrollton, Texas, United States, 75010
Sponsors and Collaborators
Sandoz
Hexal AG

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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT03974100     History of Changes
Obsolete Identifiers: NCT03991338
Other Study ID Numbers: CGP24112301
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs