Postmenopausal OsteoporosisPhase 3NCT02791516
A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis
A Phase 3 study testing Romosozumab in people with Postmenopausal Osteoporosis, run by Amgen at 10 sites in South Korea.
Trial summary
The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis. Read more about this study
- Who is it for?
- Ages 55 to 90 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Romosozumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 16 Jan 2017to 21 Dec 2018
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment.
- Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to screening.
- BMD T-score </= -2.50 at the lumbar spine, total hip or femoral neck.
- At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by DXA.
- Other inclusion criteria may apply.
Who cannot join
- Subjects with a BMD T-score </= -4.0 at the lumbar spine, total hip, or femoral neck.
- History of hip fracture.
- Bone disease other than osteoporosis/ or evidence of any other clinically significant disorder, condition/ or disease or significant laboratory abnormalities.
- Known sensitivity or intolerance calcium and vitamin D products.
- Other exclusion criteria may apply.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Research Site
Busan, 602-739
Research Site
Gwangju, 501-757
Research Site
Namdong-gu, Incheon, 21565
Research Site
Seongnam Si Gyeonggi Do, 463-707
Research Site
Seoul, 120-752
Research Site
Seoul, 135-710
Research Site
Seoul, 136-705
Research Site
Seoul, 138-736
Research Site
Seoul, 150-713
Research Site
Suwon-si, Gyeonggi-do, 443-380
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Postmenopausal South Korean Women With Osteoporosis
The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Romosozumab, Placebo
- Keywords
- Osteoporosis., Osteoporosis-Postmenopausal., Bone Diseases-Metabolic., Bone Diseases., Musculoskeletal Diseases.
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis, Bone Diseases, Metabolic, Bone Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomosozumabDrug
Also called AMG 785, Evenity
Administered by subcutaneous injection once a month (QM)
PlaceboDrug
Administered by subcutaneous injections once a month
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo subcutaneous injection once a month for 6 months. Receives: Drug: Placebo |
| Romosozumab | Experimental | Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months. Receives: Drug: Romosozumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine
Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Measured: Baseline and month 6
Secondary outcomes (2)
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip
Bone mineral density (BMD) at the total hip was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Measured: Baseline and month 6
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck
Bone mineral density (BMD) at the femoral neck was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Measured: Baseline and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start16 Jan 2017
- Primary completion12 Feb 2018
- Study completion21 Dec 2018
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 (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791516
- Sponsor's protocol ID
- 20150242
- Status last verified
- Sep 2019
- First submitted
- 2 Jun 2016
- Last updated
- 7 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baek KH, Chung YS, Koh JM, Kim IJ, Kim KM, Min YK, Park KD, Dinavahi R, Maddox J, Yang W, Kim S, Lee SJ, Cho H, Lim SK. Romosozumab in Postmenopausal Korean Women with Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study. Endocrinol Metab (Seoul). 2021 Feb;36(1):60-69. doi: 10.3803/EnM.2020.848. Epub 2021 Feb 24.
PubMed 33677928
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Postmenopausal South Korean Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT02791516
- Acronym / sponsor ID
- 20150242
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Osteoporosis., Osteoporosis-Postmenopausal., Bone Diseases-Metabolic., Bone Diseases., Musculoskeletal Diseases.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo subcutaneous injection once a month for 6 months. |
| Romosozumab | Experimental | Drug: RomosozumabParticipants received 210 mg romosozumab by subcutaneous injection once a month for 6 months. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment.
- Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to screening.
- BMD T-score </= -2.50 at the lumbar spine, total hip or femoral neck.
- At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by DXA.
- Other inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Subjects with a BMD T-score </= -4.0 at the lumbar spine, total hip, or femoral neck.
- History of hip fracture.
- Bone disease other than osteoporosis/ or evidence of any other clinically significant disorder, condition/ or disease or significant laboratory abnormalities.
- Known sensitivity or intolerance calcium and vitamin D products.
- Other exclusion criteria may apply.
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 |
|---|---|---|
| RomosozumabAlso: AMG 785, EvenityAdministered by subcutaneous injection once a month (QM) | Drug | Romosozumab |
| PlaceboAdministered by subcutaneous injections once a month | Drug | Placebo |
Primary outcome
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine
Time frame: Baseline and month 6
Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
2 secondary outcomes
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip
Time frame: Baseline and month 6
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck
Time frame: Baseline and month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33677928Baek KH, Chung YS, Koh JM, Kim IJ, Kim KM, Min YK, Park KD, Dinavahi R, Maddox J, Yang W, Kim S, Lee SJ, Cho H, Lim SK. Romosozumab in Postmenopausal Korean Women with Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study. Endocrinol Metab (Seoul). 2021 Feb;36(1):60-69. doi: 10.3803/EnM.2020.848. Epub 2021 Feb 24.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
10 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 Romosozumab in people with Postmenopausal Osteoporosis, run by Amgen at 10 sites in South Korea.
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 5 inclusion and 5 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 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. 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. Some participants in this study may receive a placebo. 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 5 Jul 2019). 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 to Month 6 in Bone Mineral Density at the Lumbar Spine (time frame: Baseline and month 6). 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 NCT02791516, which also lists 1 linked publication.
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 7 Oct 2019.