Clinical Trials Logo
  1. Home
  2. Postmenopausal Osteoporosis
  3. NCT04664959

A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

Postmenopausal Osteoporosis Clinical Trial

Official title:
A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia® in Postmenopausal Women With Osteoporosis

Clinical Trial Summary

This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.

Clinical Trial Description

Subjects will be randomised in a 1:1 ratio to receive either SB16 or Prolia®. At Month 12, subjects in Prolia® treatment group will be randomised again in a 1:1 ratio to either continue on Prolia® treatment or be transitioned to SB16 treatment. Investigational product (60 mg in 1 mL of SB16 or Prolia®) will be given subcutaneously every 6 months up to Month 12, and the last assessment will be done at Month 18. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04664959
Study type Interventional
Source Samsung Bioepis Co., Ltd.
Contact
Status Completed
Phase Phase 3
Start date November 26, 2020
Completion date December 19, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT05087030 - Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis Phase 3
Completed NCT01544894 - Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis Phase 4
Completed NCT00377819 - Study of Transitioning From Alendronate to Denosumab Phase 3
Completed NCT00381251 - Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. Phase 1
Completed NCT00239629 - Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial Phase 4
Completed NCT04026256 - Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration Phase 4
Terminated NCT00529373 - A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018) Phase 3
Completed NCT00092014 - A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211) Phase 3
Recruiting NCT06079476 - A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture. Phase 4
Not yet recruiting NCT04719650 - Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid Phase 4
Recruiting NCT02981732 - CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome N/A
Completed NCT01709110 - VERtebral Fracture Treatment Comparisons in Osteoporotic Women Phase 4
Completed NCT01348243 - Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis Phase 3
Completed NCT00541658 - A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis Phase 3
Completed NCT00395395 - Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women Phase 1
Completed NCT00247273 - A Study of Monthly Risedronate for Osteoporosis Phase 3
Active, not recruiting NCT03720886 - G56W1 in Women With Postmenopausal Osteoporosis Phase 1/Phase 2
Completed NCT01668589 - Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis N/A
Not yet recruiting NCT04719481 - Pravastatin Reduces Acute Phase Response of Zoledronic Acid Phase 4
Completed NCT01221727 - The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam Phase 1