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Completed

NCT Number: NCT04729621

A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis

The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)

Completed

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Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

60 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Teva Site 203, Blagoevgrad, Bulgaria

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About this study

This is a multinational, multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of TVB-009 compared to Prolia® administered subcutaneously at doses of 60 mg every 26 weeks. Approximately 326 postmenopausal women with osteoporosis will be randomized to receive either TVB-009 or Prolia®. At week 52, patients in the Prolia® arm will be re-randomized 1:1 to either continue with a third dose of Prolia® or transition to TVB-009 and receive a single dose of TVB-009 in the transition period to assess immunogenicity and safety after a transition from Prolia® to TVB-009. The total treatment duration for each patient is 78 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal womeen (≥60 and ≤90 years) with a diagnosis of osteoporosis
  • Body weight ≥50 kg and ≤90 kg
  • Bone Mineral Density (BMD) measurement T score of less than -2.5 but not less than -4.0 by dual-energy X-ray absorptiometry (DXA) at the lumbar spine at screening
  • At least 3 vertebrae in the L1 L4 region that are evaluable by dual-energy X-ray absorptiometry (DXA)

Exclusion criteria

  • One severe or more than two moderate vertebral fractures
  • History and/or presence of hip fracture or atypical femur fracture
  • Any prior treatment with denosumab
  • Ongoing use of any bone active drugs which can affect Bone Mineral Density (BMD)
  • Vitamin D deficiency or hyper- or hypocalcemiacium at screening
  • Hyperthyroidism, hypothyroidism, hypoparathyroidism or hyperparathyroidism
  • Any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study

Other Inclusion/exclusion criteria may apply

Treatment and study plan

TVB-009

Combination Product

TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia®

Combination Product

Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Primary outcomes

  1. Percent Change From Baseline in LS-BMD at Week 52

    Time frame: Baseline and week 52

    Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52

Secondary outcomes

  1. Percent Change From Baseline in sCTX-1 at Week 26

    Time frame: Baseline and week 26

    Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen at week 26

  2. Percent Change From Baseline in LS-BMD at Week 26

    Time frame: Baseline and week 26

    Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 26

  3. Percent Change From Baseline in Femoral Neck BMD at Week 26

    Time frame: Baseline, week 26

    Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 26

  4. Percent Change From Baseline in Total Hip BMD at Week 26

    Time frame: Baseline, week 26

    Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 26

  5. Percent Change From Baseline in sCTX-1

    Time frame: Baseline through Week 52

    Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen

  6. Percentage of Participatns With sCTX-1 Suppression at Week 4

    Time frame: Week 4

    Proportion of patients with suppression of serum C-telopeptide cross-link of type 1 collagen at week 4

  7. Percent Change From Baseline in P1NP

    Time frame: Baseline through Week 52

    Percent change from baseline in procollagen type 1 N propeptide (P1NP) to Week 52

  8. Number of Fractures up to Week 52

    Time frame: Up to week 52

    Number of patients with who experienced any new fractures up to week 52.

  9. Percent Change From Week 52 in LS-BMD by DXA at Week 78

    Time frame: Week 52 through week 78

    Percent change from week 52 in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78

  10. Percent Change From Week 52 in Femoral Neck BMD by DXA at Week 78

    Time frame: Week 52 through week 78

    Percent change from week 52 in femoral neck bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78

  11. Percent Change From Week 52 in Total Hip BMD by DXA at Week 78

    Time frame: Week 52 through week 78

    Percent change from week 52 in total hip bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78

  12. Difference Between Percent Change From Baseline in sCTX-1 Between Week 52 and Week 78

    Time frame: Baseline, Week 52, Week 78

    Difference in the percent change from baseline in serum C-telopeptide cross-link of type 1 collagen from baseline to Week 78 as compared to baseline to Week 52

  13. Difference Between Percent Change From Baseline in P1NP Between Week 52 and Week 78

    Time frame: Baseline, Week 52, Week 78

    The difference in the Percent change from baseline in procollagen type 1 N propeptide at Week 78 compared to Week 52.

  14. Number of Patients With Fractures Between Week 52 and Week 78

    Time frame: Week 52 through week 78

    Number of patients experiencing new fractures between week 52 and week 78

  15. Incidence of Adverse Event

    Time frame: Up to week 52

    Number of patients reporting at least one treatment-emergent adverse event up to week 52

  16. Incidence of Adverse Events in the Transition Period

    Time frame: Week 52 through week 78

    Number of patients reporting at least one treatment-emergent adverse event between weeks 52 and 78

  17. Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period

    Time frame: Anytime Post Baseline through Week 52

    Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline through Week 52

  18. Incidence of Antidrug Antibodies (ADAs) in the Transition Period

    Time frame: Anytime in Week 52 through Week 78

    Number of patients with confirmed positive antidrug antibodies (ADAs) at Week 65

  19. Percent Change From Baseline in Femoral Neck BMD at Week 52

    Time frame: Baseline through Week 52

    Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 52

  20. Percent Change From Baseline in Total Hip BMD at Week 52

    Time frame: Baseline through Week 52

    Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52

  21. Number of TEAEs Leading to Patient Withdraw From the Study

    Time frame: Main Treatment Period = Baseline-Week 52; Transition period = Week 52-78

    Number of patients that withdraw or are removed from the study due to treatment emergent adverse events from both the main and transition treatment periods.

  22. Local Tolerability at Injection Site

    Time frame: Main Treatment Period = Day 1 & Week 26; Transition Treatment Period = Week 52

    Number of patients who report Injection Site Reactions at Day 1, Week 26, or Week 52.

Sponsors and collaborators

Lead sponsor

Teva Pharmaceuticals USA

Industry

Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

Registry information

Official study title

A Randomized, Double-Blind, Multinational, Multicenter Study to Compare Efficacy, Safety, and Immunogenicity of TVB-009P and Denosumab (Prolia®) in Patients With Postmenopausal Osteoporosis

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 28, 2021
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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