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A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT04664959•Samsung Bioepis Co., Ltd.

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

55 - 80 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Postmenopausal women who are 55 to 80 years of age at Screening
•Ambulatory and visually unimpaired to participate in the study at Screening, in the opinion of the Investigator
•Absolute BMD consistent with T-score at the total hip or lumbar spine of -4 and -2.5 at Screening
•At least three evaluable vertebrae within L1 to L4, one evaluable femoral neck, and one evaluable hip joint for BMD measurement at Screening
•Biologic naïve at Screening
•Body weight of 50 kg and 90 kg at Screening

Exclusion Criteria

•One severe or more than two moderate vertebral fractures on spinal X-ray according to Genant classification at Screening
•History of hip fracture or bilateral hip replacement at Screening
•Uncorrected vitamin D deficiency at Screening
•Hypercalcemia or hypocalcaemia at Screening
•Inadequate haematological function at Screening
•Inadequate renal or hepatic function at Screening
•Known allergic reactions, hypersensitivity, or intolerance to denosumab or to any ingredients of the IP, including latex allergy or hereditary problems of fructose intolerance at Screening
•May not tolerate long-term calcium or vitamin D supplementation or subject with malabsorption of calcium or vitamin D supplements, in the opinion of the Investigator, at Screening
•Use of any of the medications that can affect BMD
•Use of any non-biologic IP that is not indicated for osteoporosis from another study or use of an investigational device at Screening
+2 more criteria

Locations (5)

SB Investigative Site

Krakow, Poland

SB Investigative Site

Lodz, Poland

SB Investigative Site

Siedlce, Poland

SB Investigative Site

Warsaw, Poland

SB Investigative Site

Zamość, Poland

Key Dates

Start Date

November 26, 2020

Primary Completion Date

June 20, 2022

Completion Date

January 3, 2023

Last Updated

February 4, 2025

Enrollment

457

ACTUAL participants

Conditions

Postmenopausal Osteoporosis

Interventions

SB16 (Proposed Denosumab Biosimilar)

DRUG

Prolia® (Denosumab)

DRUG

Anabolic Therapy in Postmenopausal Osteoporosis

NCT05010590

Postmenopausal Osteoporosis

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NOT_YET_RECRUITING

AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

NCT07329543

OsteoporosisPostmenopausal Osteoporosis

View study

WITHDRAWNNA

Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Anabolic Therapy in Postmenopausal Osteoporosis

AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis

Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis

Efficacy and Safety of Minodronate in Patients With Low Back Pain