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A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Double-blind, Randomized, Multicenter, Multiple-dose, 2-arm, Parallel-group Study to Evaluate Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 - Proposed Biosimilar to Denosumab With Prolia® in Postmenopausal Women With Osteoporosis (LUMIADE-3 Study)

NCT04934072•Fresenius Kabi SwissBioSim GmbH

View on ClinicalTrials.gov

Summary

The primary objective of this study is to demonstrate equivalent efficacy of the proposed biosimilar denosumab FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO).

Eligibility

Age

55 - 85 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Female ≥55 to ≤85 years of age, inclusive, at screening.
•2. Have a body mass index (BMI) ≥18 to ≤32 kg/m\^2.
•3. Participant should have confirmed postmenopausal status, defined as age-related or early/premature amenorrhea ≥12 consecutive months and increased follicle-stimulating hormone (FSH) \>40 mIU/mL at screening; or surgical menopause (bilateral oophorectomy with or without hysterectomy) ≥12 months prior to screening.
•4. Absolute bone mineral density (BMD) consistent with T-score ≤-2.5 and ≥-4.0 at the lumbar spine as measured by dual energy x-ray absorptiometry (DXA) as per central assessment.
•5. At least 2 vertebrae in the lumbar vertebrae 1 to lumbar vertebrae 4 (L1-L4) region and at least 1 hip joint are evaluable by DXA.
•6. Clinically acceptable physical examinations and laboratory tests and no history or evidence of any clinically significant concomitant medical disorder that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with study evaluations or procedures.
•7. Written informed consent including accepting a separate Information Sheet containing important information about COVID-19 and its general risks for participants participating in the clinical trial.

Exclusion Criteria

•Disease-related
•1. History and/or presence of 1 severe or \>2 moderate vertebral fractures or hip fracture confirmed by x-ray.
•2. Presence of active healing fracture at screening.
•3. History and/or presence of bone-related disorders, such as but not limited to Paget's disease, osteomalacia, hyperparathyroidism (or parathyroid disorders), or renal osteodystrophy.
•4. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (eg, tooth extraction, dental implants, or oral surgery in the past 6 months), poor oral hygiene, periodontal, and/or pre-existing dental disease as assessed by the Investigator.
•5. Evidence of hypocalcemia (albumin-adjusted serum calcium \<2.13 mmol/L or \<8.5 mg/dL) or hypercalcemia (albumin-adjusted serum calcium \>2.6 mmol/L or \>10.5 mg/dL) as assessed by the central laboratory at screening.
•6. Vitamin D deficiency (25-hydroxy vitamin D levels \<12 ng/mL) as assessed by central laboratory at screening (retest is allowed once).
•7. Known intolerance to calcium or vitamin D supplements.
•Other Medical Conditions
•8. Known or suspected clinically relevant drug hypersensitivity to any components of the study drug, comparable drugs, or to latex.
+18 more criteria

Locations (76)

Diagnostic Consultative Center Aleksandrovska

Sofia, Sofia-Grad, Bulgaria

Diagnostic Consultative Center (DCC) 17 - Sofia

Sofia, Sofia-Grad, Bulgaria

Medical Center N. I. Pirogov

Sofia, Sofia-Grad, Bulgaria

Medical Center Hipokrat 2000 OOD

Haskovo, Bulgaria

Medical Center Medconsult Pleven

Pleven, Bulgaria

Palmed University Multidisciplinary Hospital for Active Treatment

Plovdiv, Bulgaria

University Multi-profile Hospital for Active Treatment - Plovdiv

Plovdiv, Bulgaria

Medical Center - Teodora EOOD

Rousse, Bulgaria

Multiprofile Hospital for Active Treatment Hadzhi Dimitar

Sliven, Bulgaria

Lyulin Hospital

Sofia, Bulgaria

Key Dates

Start Date

June 16, 2021

Primary Completion Date

August 7, 2023

Completion Date

August 7, 2023

Last Updated

February 27, 2025

Enrollment

553

ACTUAL participants

Conditions

Postmenopausal Osteoporosis

Interventions

FKS518

DRUG

US-licensed Prolia (Amgen)

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

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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 27, 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.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 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

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