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Postmenopausal OsteoporosisPhase 3NCT04934072

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

A Phase 3 study testing FKS518 and US-licensed Prolia (Amgen) in people with Postmenopausal Osteoporosis, run by Fresenius Kabi SwissBioSim GmbH at 76 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 55 to 85 years, women only
Conditions the study is for
Postmenopausal Osteoporosis
What is being tested?
FKS518 and US-licensed Prolia (Amgen)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
553 participants
Where
76 sitesin 6 countries
Study dates
16 Jun 2021to 7 Aug 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female ≥55 to ≤85 years of age, inclusive, at screening.
  • Have a body mass index (BMI) ≥18 to ≤32 kg/m^2.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Disease-related
  • History and/or presence of 1 severe or >2 moderate vertebral fractures or hip fracture confirmed by x-ray.
  • Presence of active healing fracture at screening.
  • 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.
  • 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.
  • 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.
Show all 28Show fewer
  • Vitamin D deficiency (25-hydroxy vitamin D levels <12 ng/mL) as assessed by central laboratory at screening (retest is allowed once).
  • Known intolerance to calcium or vitamin D supplements.
  • Other Medical Conditions
  • Known or suspected clinically relevant drug hypersensitivity to any components of the study drug, comparable drugs, or to latex.
  • Renal impairment: creatinine clearance <30 mL/min at screening or receiving dialysis.
  • Medical evidence of current or history of primary or secondary immunodeficiency.
  • Infection-related exclusions as further defined in the protocol.
  • Major surgical procedure within 8 weeks prior to the screening or scheduled during the study.
  • Current or history of any malignancy, or myeloproliferative, or lymphoproliferative disease within 5 years before screening.
  • History of clinically significant drug or alcohol abuse within the last year prior to randomization.
  • Prior denosumab (Prolia, Xgeva, or proposed denosumab biosimilar) exposure.
  • Prior use of fluoride within the 5 years before inclusion in the study.
  • Any current or prior use of strontium ranelate.
  • Any current or prior use of intravenous bisphosphonates.
  • Current or prior use of teriparatide and other parathormone (PTH) analogues within 12 months before screening.
  • Current or prior use of systemic oral or transdermal estrogen or selective estrogen receptor modulators or tibolone within 6 months before screening.
  • Current or prior use of calcitonin or cinacalcet within 3 months before screening or any cathepsin K inhibitor (eg, odanacatib) within 18 months before screening.
  • Current or prior use of romosozumab or antisclerostin antibody.
  • Current or prior use of other osteoporotic agents used for the prevention or treatment of osteoporosis.
  • Current use within 3 months before screening of any medication with known influence on the skeletal system (eg, systemic corticosteroids, heparin, lithium, etc) with exceptions described in the protocol.
  • Concomitant treatment with another biologic drug.
  • Have received a COVID-19 vaccine within 4 weeks before randomization or COVID-19 vaccination is ongoing at the time of screening.

Trial locations and contacts

76 sites in 6 countries.

76 sites in 6 countries

Poland29 sites

  • Osteo-Medic sc dr diabetolog Katarzyna Wasilewska

    Bialystok, Podlaskie Voivodeship, 15-351

  • ClinicMed

    Bialystok, Podlaskie Voivodeship, 15-879

  • Nasz Lekarz O?rodek Bada? Klinicznych - Bydgoszcz

    Bydgoszcz, Pomeranian Voivodeship, 85-065

  • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

    Bydgoszcz, Pomeranian Voivodeship, 85-168

  • Centrum Kliniczno Badawcze J Brzezicki B Górnikiewicz Brzezicka Lekarze

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Ambulatorium Sp z o.o. - Elblag

    Elblag, Zulawy, 82-300

  • Centrum Medyczne Pratia - Gdynia

    Gdynia, Pomeranian Voivodeship, 81-338

  • Centrum Medyczne Pratia - Gdynia

    Gdynia, Pomeranian Voivodeship, 81-340

  • Gabinet diagnostyki i leczenia osteoporozy

    Gliwice, Silesian Voivodeship, 44-122

  • Centrum Medyczne All-Med

    Krakow, Lesser Poland Voivodeship, 30-033

  • Pratia MCM Krakow

    Krakow, Lesser Poland Voivodeship, 30-510

  • Centrum Medyczne All-Med

    Krakow, 31-023

  • SOMED CR - ?od?

    Lodz, 90-368

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, 67-100

  • Centrum Medyczne Solumed

    Pozna?, Greater Poland Voivodeship, 60-529

  • Centrum Bada? Klinicznych

    Poznan, Greater Poland Voivodeship, 60-773

  • RCMed Oddzial Sochaczew

    Sochaczew, Masovian Voivodeship, 96-500

  • Twoja Przychodnia Szczeci?skie Centrum Medyczne

    Szczecin, 71-434

  • Samodzielny Publiczny Zespo? Opieki Zdrowotnej w Tomaszow Lubelski

    Tomaszów Lubelski, 22-600

  • Nasz Lekarz Przychodnie Medyczne

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Medycyna Kliniczna

    Warsaw, Masovian Voivodeship, 00-874

  • Centrum Medyczne AMED - Warszawa Targowek

    Warsaw, Masovian Voivodeship, 01-518

  • Rheuma Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy

    Warsaw, Masovian Voivodeship, 02-118

  • Twoja Przychodnia Szczeci?skie Centrum Medyczne

    Warsaw, Masovian Voivodeship, 02-777

  • SOMED CR - ?od?

    Warsaw, Masovian Voivodeship, 04-730

  • Klinika Reuma Park sp. z o.o. sp.k - Centrum Medyczne Reuma Park

    Warsaw, 02-691

  • FutureMeds

    Wroclaw, Lower Silesian Voivodeship, 50-088

  • Wromedica Centrum Zdrowia

    Wroclaw, Lower Silesian Voivodeship, 51-685

  • Centrum Medyczne Oporow

    Wroclaw, Lower Silesian Voivodeship, 52-416

Other trials in Poland

Hungary17 sites

  • Drug Research Center Balatonfured

    Balatonfüred, 8230

  • Revita Rendel?

    Budapest, 1027

  • Clinexpert Gyogycentrum

    Budapest, 1033

  • Obudai Egeszsegugyi Centrum

    Budapest, 1036

  • Semmelweis Egyetem - I. sz. Belgyogyaszati Klinika

    Budapest, 1083

  • Szent Anna Magan N?gyogyaszati

    Debrecen, Hajdú-Bihar, 4024

  • Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus

    Debrecen, 4031

  • Markhot Ferenc Oktatokorhaz es Rendel?intezet

    Eger, Heves County, 3300

  • Markhot Ferenc Oktatokorhaz es Rendel?intezet

    Eger, 3300

  • Kalocsai Szent Kereszt Korhaz

    Kalocsa, 6300

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, Pest County, 2143

  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar

    Szeged, Csongr, 6720

  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar

    Szeged, Csongrád megye, 6725

  • CMed Rehabilitacios es Diagnosztikai Kozpont / Saldinvest Kft.

    Székesfehérvár, 8000

  • Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz

    Szentes, Csongrád megye, 6600

  • Vital Medical Center - Reumatologia

    Veszprém, 8200

  • Obudai Egeszsegugyi Centrum

    Zalaegerszeg, Zala County, 8900

Other trials in Hungary

Bulgaria12 sites

  • Medical Center Hipokrat 2000 OOD

    Haskovo, 6300

  • Medical Center Medconsult Pleven

    Pleven, 5800

  • Palmed University Multidisciplinary Hospital for Active Treatment

    Plovdiv, 4002

  • University Multi-profile Hospital for Active Treatment - Plovdiv

    Plovdiv, 4003

  • Medical Center - Teodora EOOD

    Rousse, 7012

  • Multiprofile Hospital for Active Treatment Hadzhi Dimitar

    Sliven, 8800

  • Diagnostic Consultative Center Aleksandrovska

    Sofia, Sofia-Grad, 1431

  • Diagnostic Consultative Center (DCC) 17 - Sofia

    Sofia, Sofia-Grad, 1505

  • Medical Center N. I. Pirogov

    Sofia, Sofia-Grad, 1612

  • Lyulin Hospital

    Sofia, 1336

  • Diagnostic and Consultative Center Equita

    Varna, 9002

  • Medical Center Sanador M

    Vidin, 3703

Other trials in Bulgaria

Georgia7 sites

  • Evex Hospitals - Caraps Medline

    Tbilisi, Borjomi, 0159

  • Georgian-Dutch Hospital

    Tbilisi, Borjomi, 0172

  • Hepatology Clinic Hepa

    Tbilisi, 0159

  • Tbilisi Heart And Vascular Clinic Ltd

    Tbilisi, 0159

  • Jerarsi Clinic

    Tbilisi, 0167

  • Raymann - Clinic of Raymann Doctors

    Tbilisi, 0186

  • MedCity Ltd.

    Tbilisi, 186

Other trials in Georgia

Czechia6 sites

  • CCR Brno

    Brno, Jihormoravsky Kraj, 602 00

  • G-Centrum Olomouc s.r.o

    Olomouc, 772 00

  • CCR Ostrava

    Ostrava, Severomoravsky Kraj, 702 00

  • Artroscan

    Ostrava-T?ebovice, 722 00

  • Medical Plus

    Uherské Hradiště, South Moravian, 686 01

  • Medical Plus

    Uherské Hradiště, 686 01

Other trials in Czechia

Estonia5 sites

  • KLV Arstikabinet

    Pärnu, Pärnumaa, 80010

  • KLV Arstikabinet

    Pärnu, 80010

  • Center for Clinical and Basic Research AS - Tallinn

    Tallinn, Harju, 10128

  • Sihtasutus Pohja-Eesti Regionaalhaigla

    Tallinn, Harju, 13419

  • Tartu Ulikooli Kliinikum

    Tartu, Tartu, 50406

Other trials in Estonia

About this study

Official title: 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)

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).

Being tested
FKS518, US-licensed Prolia (Amgen)
Keywords
Postmenopausal Osteoporosis, FKS518, Denosumab, US-licensed Prolia
Medical subject headings
Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FKS518Drug

    Also called Denosumab biosimilar

    subcutaneously by single-use prefilled syringe (PFS)

  • US-licensed Prolia (Amgen)Drug

    Also called Denosumab

    subcutaneously by single-use PFS

Study groups in NCT04934072
Study groupRoleWhat they receive
FKS518ExperimentalFKS518 was administered on Day 1, and then every 26 weeks (6 months), i.e., Week 26 and Week 52, at a dose of 60 mg for a total of 3 administrations.
Receives: Drug: FKS518
US-ProliaActive comparatorUS-Prolia was administered on Day 1, and then every 26 weeks (6 months), i.e., Week 26 and Week 52, at a dose of 60 mg for a total of 3 administrations.
Receives: Drug: US-licensed Prolia (Amgen)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Change From Baseline in LS-BMD by DXA

    Bone density was measured at the lumbar spine from L1 through L4. Per FDA request for this study, data were analyzed by non-inferiority and non-superiority analyses. Decreased BMD is associated with risk of fracture.

    Measured: Baseline and Week 52

Secondary outcomes (8)

  1. Area Under the Effect Curve (AUEC) of Serum C-terminal Cross-linking Telopeptide of Type 1 Collagen (CTX)

    Area under the effect curve for the (untransformed) biomarker concentrations from baseline up to Week 26. Any possible rebound effect where biomarker concentrations rose above baseline was not taken into account, and only the area below baseline was considered in this parameter.

    Measured: Baseline to Week 26

  2. Percentage Change From Baseline in BMD at Femoral Neck and Total Hip by DXA

    The proximal femur (inclusive of femoral neck and total hip) DXA scans were obtained from the left side when possible. If the right side had to be used (e.g., due to implants) or was inadvertently used at baseline, then it had to be used consistently throughout the study. Data reported are for one half of the body only.

    Measured: Baseline and Week 52

  3. Percentage Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)

    P1NP is a bone biomarker. Serum samples were collected for analysis of P1NP to evaluate bone formation (P1NP) in response to treatment with FKS518 and US-Prolia. A decrease in the serum levels of P1NP is expected following treatment with denosumab and is suggestive of improvement.

    Measured: Baseline and Week 52 pre dose

  4. Percentage Change From Baseline in Serum C-terminal Cross-linking Telopeptide of Type 1 Collagen (CTX)

    Serum CTX is a bone biomarker. Serum samples were collected for analysis of CTX to evaluate bone resorption in response to treatment with FKS518 or US-Prolia.

    A decrease in the serum levels of CTX is expected following treatment with US-Prolia and is suggestive of improvement.

    Measured: Baseline and Week 52 pre dose

  5. Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

    Treatment-emergence was defined as AEs that began or increased in severity or frequency on or after the date of first administration of IP in a given treatment Period (Core or Transition) up to the Early Termination/End of Study Visit.

    Measured: Day 1 to Week 78

  6. Number of Participants Who Experienced a Treatment-Emergent Serious Adverse Event (TESAE)

    Treatment-emergence was defined as SAEs that began or increased in severity or frequency on or after the date of first administration of IP up to the Early Termination/End of Study Visit.

    Measured: Day 1 to Week 78

  7. Number of Participants Who Experienced a Treatment-emergent Adverse Event of Special Interest (AESI)

    A Treatment-emergent AESI is defined as drug-related hypersensitivity/allergic reactions (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≥3 or reported as serious adverse events [SAEs]) and AEs leading to IP discontinuation or study withdrawal.

    Measured: Day 1 to Week 78

  8. Number of Participants Who Experienced an Injection Site Reaction (ISR)

    Local tolerability in terms of ISRs was assessed by inspection of the skin and appendages in proximity to the site of administration. The injection site was the abdomen, and the IP was injected slowly. This local tolerability assessment was performed by the Investigator or designee to determine the presence of e.g., erythema, rash, tenderness, swelling, itching, bruising, pain, extravasation, phlebitis, or other types of reaction. The Investigator was also requested to ask participants during assessment about any such reactions that may have occurred since last assessment.

    Measured: Day 1 to Week 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2021
  2. Study start16 Jun 2021
  3. Primary completion7 Aug 2023
  4. Study completion7 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
553 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04934072
Sponsor's protocol ID
FKS518-002
Other IDs
2020-004422-31
Status last verified
Feb 2025
First submitted
3 Jun 2021
Last updated
27 Feb 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FKS518 and US-licensed Prolia (Amgen) in people with Postmenopausal Osteoporosis, run by Fresenius Kabi SwissBioSim GmbH at 76 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Poland, Hungary, Bulgaria, Georgia, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in LS-BMD by DXA (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04934072.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.

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