Postmenopausal OsteoporosisPhase 3NCT04664959
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
A Phase 3 study testing SB16 (Proposed Denosumab Biosimilar) and Prolia® (Denosumab) in people with Postmenopausal Osteoporosis, run by Samsung Bioepis Co., Ltd. at 5 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- SB16 (Proposed Denosumab Biosimilar) and Prolia® (Denosumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 5 sitesPoland
- Study dates
- 26 Nov 2020to 3 Jan 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
- Non-osteoporosis medical conditions that can affect BMD at Screening
- Any clinically significant disease or disorder or laboratory abnormality which, in the opinion of the Investigator, would prevent the subject from completing the study or the interpretation of the study results at Screening and Randomisation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites
SB Investigative Site
Krakow
SB Investigative Site
Lodz
SB Investigative Site
Siedlce
SB Investigative Site
Warsaw
SB Investigative Site
Zamość
About this study
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
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.
Read the 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.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- SB16 (Proposed Denosumab Biosimilar), Prolia® (Denosumab)
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB16 (Proposed Denosumab Biosimilar)Drug
Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months.
At Month 12, subjects transited from Prolia® group to SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously.
Prolia® (Denosumab)Drug
Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months.
| Study group | Role | What they receive |
|---|---|---|
| SB16 (Proposed Denosumab Biosimilar) | Experimental | Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months. Receives: Drug: SB16 (Proposed Denosumab Biosimilar) |
| Prolia® (Denosumab) | Active comparator | Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months.
At Month 12, subjects in Prolia® treatment group will be re-randomised in a 1:1 ratio to either continue on Prolia® treatment or be transitioned to SB16 treatment. After re-randomisation, subjects transited to SB16 group will receive SB16, and subjects remaining in Prolia® group will continue to receive Prolia® at Month 12. Receives: Drug: SB16 (Proposed Denosumab Biosimilar); Drug: Prolia® (Denosumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start26 Nov 2020
- Primary completion20 Jun 2022
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664959
- Sponsor's protocol ID
- SB16-3001
- Status last verified
- Jan 2025
- First submitted
- 10 Dec 2020
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chung YS, Langdahl B, Plebanski R, Czerwinski E, Dokoupilova E, Supronik J, Rosa J, Mydlak A, Sapula R, Rowinska-Osuch A, Baek KH, Urboniene A, Mordaka R, Ahn S, Rho YH, Ban J, Eastell R. SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial. Bone. 2025 Mar;192:117371. doi: 10.1016/j.bone.2024.117371. Epub 2024 Dec 12.
PubMed 39674388Langdahl B, Chung YS, Plebanski R, Czerwinski E, Dokoupilova E, Supronik J, Rosa J, Mydlak A, Rowinska-Osuch A, Baek KH, Urboniene A, Mordaka R, Ahn S, Rho YH, Ban J, Eastell R. Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12. J Clin Endocrinol Metab. 2025 May 19;110(6):e1951-e1958. doi: 10.1210/clinem/dgae611.
PubMed 39243386
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04664959
- Acronym / sponsor ID
- SB16-3001
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB16 (Proposed Denosumab Biosimilar) | Experimental | Drug: SB16 (Proposed Denosumab Biosimilar)Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months. |
| Prolia® (Denosumab) | Active comparator | Drug: SB16 (Proposed Denosumab Biosimilar), Drug: Prolia® (Denosumab)Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months. At Month 12, subjects in Prolia® treatment group will be re-randomised in a 1:1 ratio to either continue on Prolia® treatment or be transitioned to SB16 treatment. After re-randomisation, subjects transited to SB16 group will receive SB16, and subjects remaining in Prolia® group will continue to receive Prolia® at Month 12. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB16 (Proposed Denosumab Biosimilar)Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months. At Month 12, subjects transited from Prolia® group to SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously. | Drug | Prolia® (Denosumab), SB16 (Proposed Denosumab Biosimilar) |
| Prolia® (Denosumab)Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months. | Drug | Prolia® (Denosumab) |
Primary outcome
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Time frame: Baseline and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39674388Chung YS, Langdahl B, Plebanski R, Czerwinski E, Dokoupilova E, Supronik J, Rosa J, Mydlak A, Sapula R, Rowinska-Osuch A, Baek KH, Urboniene A, Mordaka R, Ahn S, Rho YH, Ban J, Eastell R. SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial. Bone. 2025 Mar;192:117371. doi: 10.1016/j.bone.2024.117371. Epub 2024 Dec 12.
- Derived from this study: PubMed 39243386Langdahl B, Chung YS, Plebanski R, Czerwinski E, Dokoupilova E, Supronik J, Rosa J, Mydlak A, Rowinska-Osuch A, Baek KH, Urboniene A, Mordaka R, Ahn S, Rho YH, Ban J, Eastell R. Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12. J Clin Endocrinol Metab. 2025 May 19;110(6):e1951-e1958. doi: 10.1210/clinem/dgae611.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SB16 (Proposed Denosumab Biosimilar) and Prolia® (Denosumab) in people with Postmenopausal Osteoporosis, run by Samsung Bioepis Co., Ltd. at 5 sites in Poland.
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 6 inclusion and 12 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 4 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 5 sites in Poland. 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 9 Jan 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?
Percent Change From Baseline in Lumbar Spine BMD at Month 12 (time frame: Baseline and Month 12). 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 NCT04664959, which also lists 2 linked publications.
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 4 Feb 2025.