Post-Menopausal OsteoporosisPhase 3NCT03432533
A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis
A Phase 3 study testing romosozumab HCP administration with PFS and romosozumab self-administration with AI/Pen in people with Post-Menopausal Osteoporosis, run by Amgen at 46 sites in 3 countries.
Trial summary
To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject self-administration with autoinjector/pen… Read more about this study
- Who is it for?
- Ages 55 to 90 years, women only
- Conditions the study is for
- Post-Menopausal Osteoporosis
- What is being tested?
- romosozumab HCP administration with PFS and romosozumab self-administration with AI/Pen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 46 sitesin 3 countries
- Study dates
- 6 Feb 2018to 8 Jan 2020
- 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
- Subject has provided informed consent/assent prior to initiation of any studyspecific activities/procedures, or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
- Postmenopausal female (postmenopausal status is defined as no vaginal bleeding or spotting for 12 consecutive months prior to screening)
- -≥ 55 to ≤ 90 years of age at the time of informed consent
- Ambulatory
- BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans -Subject has at least 2 vertebrae in the L1-L4 region evaluable by DXA, as assessed by the principal investigator or designee
- Subject has at least 1 hip evaluable by DXA, as assessed by the principal investigator or designee
Show all 14Show fewer
- Subject has history of fragility (ie, osteoporosis-related fracture) or subject meets at least 2 of the following clinical risk factors for fracture
- ≥ 70 years of age at the time of informed consent
- BMD T-score ≤ -3.00 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans
- current smoker
- consumption of ≥ 3 glasses of alcohol a day
- parental history of fragility (ie, osteoporosis-related) fracture
- body weight ≤ 125 pounds/56 kilogram
- Ability to follow and understand instructions and the ability to self-inject, per investigator judgement
Who cannot join
- History of osteonecrosis of the jaw and/or atypical femoral fracture
- History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
- Subject with reported history of hearing loss associated with cranial nerve VIII compression due to excessive bone growth (eg, as seen in conditions such as Paget's disease, sclerosteosis and osteopetrosis)
- Vitamin D insufficiency [defined as serum 25 (OH) vitamin D levels < 20 ng/mL], as determined by the central laboratory. Vitamin D repletion will be permitted a nd subjects may be rescreened
- Current hyperthyroidism (unless well controlled on stable antithyroid therapy) by subject report or by chart review, per principal investigator evaluation
- Current clinical hypothyroidism (unless well controlled on stable thyroid replacement therapy) by subject report or by chart review, per principal investigator evaluation normal range, per subject medical history. Uncontrolled hyperparathyroidism is defined as: parathyroid hormone (PTH) outside the normal range in subjects with concurrent hypercalcemia; or PTH values > 20% above the upper limit of normal (ULN) in normocalcemic subjects.
- Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory. Serum calcium levels may be retested once in case of an elevated serum calcium level within 1.1x the ULN as assessed by the central laboratory
Trial locations and contacts
46 sites in 3 countries.
46 sites in 3 countries
United States35 sites
Research Site
Atlanta, Georgia, 30319
Research Site
Atlanta, Georgia, 30342
Research Site
Birmingham, Alabama, 35205
Research Site
Birmingham, Alabama, 35294
Research Site
Bridgeton, Missouri, 63044
Research Site
Chandler, Arizona, 85224
Research Site
Charlotte, North Carolina, 28204
Research Site
Chesapeake, Virginia, 23320
Research Site
Cincinnati, Ohio, 45242
Research Site
Cypress, California, 90630
Research Site
Danville, Virginia, 24541
Research Site
Delray Beach, Florida, 33446
Research Site
Denver, Colorado, 80230
Research Site
Duncansville, Pennsylvania, 16635
Research Site
Fargo, North Dakota, 58103
Research Site
Franklin, Wisconsin, 53132
Research Site
Fullerton, California, 92835
Research Site
Glendale, California, 91206
Research Site
Golden, Colorado, 80401
Research Site
Great Neck, New York, 11021
Research Site
Huntsville, Alabama, 35801
Research Site
Laguna Hills, California, 92653
Research Site
Las Vegas, Nevada, 89148
Research Site
Mesa, Arizona, 85213
Research Site
Renton, Washington, 98057
Research Site
Salt Lake City, Utah, 84107
Research Site
San Antonio, Texas, 78209
Research Site
Santa Maria, California, 93454
Research Site
South Miami, Florida, 33143
Research Site
Spartanburg, South Carolina, 29303
Research Site
Springfield, Missouri, 65802
Research Site
Summerville, South Carolina, 29486
Research Site
Tuscaloosa, Alabama, 35406
Research Site
Tustin, California, 92780
Research Site
Wyomissing, Pennsylvania, 19610
United Kingdom7 sites
Research Site
Chorley, PR7 7NA
Research Site
Edinburgh, EH4 2XU
Research Site
Liverpool, L22 0LG
Research Site
London, DA14 6LT
Research Site
Manchester, M15 6SX
Research Site
Northwood, HA6 2RN
Research Site
Romford, RM1 3PJ
Poland4 sites
Research Site
Bialystok, 15-351
Research Site
Lodz, 90-558
Research Site
Świdnik, 21-040
Research Site
Warsaw, 01-192
About this study
Official title: A Randomized, Multicenter, Open-label, Parallel Group Study in Postmenopausal Women With Osteoporosis to Evaluate the Noninferiority of Subject-administered Romosozumab Via Autoinjector/Pen vs Healthcare Provider-administered Romosozumab Via Prefilled Syringe
To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject self-administration with autoinjector/pen (AI/Pen)
- Conditions
- Post-Menopausal Osteoporosis
- Being tested
- romosozumab HCP administration with PFS, romosozumab self-administration with AI/Pen
- Keywords
- Post-Menopausal osteoporosis
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
romosozumab HCP administration with PFSDrug
Also called Evenity, AMG785
210 mg romosozumab SC QM by HCP administration with 2 PFS
romosozumab self-administration with AI/PenDevice
Also called Evenity, AMG785
210 mg romosozumab SC QM by self-administration with 2 AI/Pens
| Study group | Role | What they receive |
|---|---|---|
| Romosozumab 210 mg QM: PFS | Active comparator | During the open-label treatment period, participants receive 210 mg romosozumab SC QM by HCP administration with PFS. Receives: Drug: romosozumab HCP administration with PFS |
| Romosozumab 210 mg QM: AI/Pen | Active comparator | During the open-label treatment period, participants receive 210 mg romosozumab SC QM by self-administration with AI/pen. Receives: Device: romosozumab self-administration with AI/Pen |
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 6
Percent change from baseline in BMD at the lumbar spine as measured by dual-energy x-ray absorptiometry (DXA).
Measured: Baseline, Month 6
Secondary outcomes (4)
Percent Change From Baseline in Total Hip BMD at Month 6
Percent change from baseline in BMD for total hip as measured by DXA.
Measured: Baseline, Month 6
Percent Change From Baseline in Femoral Neck BMD at Month 6
Percent change from baseline in BMD at femoral neck as measured by DXA.
Measured: Baseline, Month 6
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
AE: any untoward medical occurrence irrespective of a causal relationship with the study treatment. SAE: any untoward medical occurrence that meets at least 1 of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important serious event. Adverse device effect: any AE related to the use of a combination product or medical device. TEAEs are those AEs occurring after first dose of study drug.
Measured: up to Month 9 (-7/+3 days)
Number of Participants Developing Anti-Romosozumab Antibodies
Participants with a negative or no result at baseline (BL) developing anti-romosozumab antibodies postbaseline, including those who were binding antibody-positive or neutralizing antibody-positive postbaseline. 'Transient' positive results are those with a negative result at the participant's last time point tested within the study period.
Measured: up to Month 9 (-7/+3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start6 Feb 2018
- Primary completion11 Apr 2019
- Study completion8 Jan 2020
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.
- Other trials for Post-Menopausal 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
- Model description
- After signing the informed consent form (ICF), subjects will undergo the following periods: * Screening period (35 days) to complete eligibility assessments * Open-label treatment period (6 months) * Follow-up period (3 months) During the open-label treatment period, subjects will be randomized to receive romosozumab either via HCP administration with PFS or via self-administration withAI/Pen. During the follow-up period, subjects will be followed for an additional 3 months to ensure appropriate follow-up for anti-romosozumab antibody formation and adverse events. The primary analysis will be performed after all subjects have had the opportunity to complete the Month 6 visit. The final analysis will be performed after all subjects have had the opportunity to complete the Month 9 visit.
- Masking
- None (open label)
- Enrolment
- 283 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
- NCT03432533
- Sponsor's protocol ID
- 20150120
- Other IDs
- 2017-003512-40, 2017
- Status last verified
- Oct 2020
- First submitted
- 30 Jan 2018
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-label, Parallel Group Study in Postmenopausal Women With Osteoporosis to Evaluate the Noninferiority of Subject-administered Romosozumab Via Autoinjector/Pen vs Healthcare Provider-administered Romosozumab Via Prefilled Syringe
- ClinicalTrials.gov ID
- NCT03432533
- Acronym / sponsor ID
- 20150120
- Conditions
- Post-Menopausal Osteoporosis
- Keywords
- Post-Menopausal osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Posted 10 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject self-administration with autoinjector/pen (AI/Pen)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After signing the informed consent form (ICF), subjects will undergo the following periods: * Screening period (35 days) to complete eligibility assessments * Open-label treatment period (6 months) * Follow-up period (3 months) During the open-label treatment period, subjects will be randomized to receive romosozumab either via HCP administration with PFS or via self-administration withAI/Pen. During the follow-up period, subjects will be followed for an additional 3 months to ensure appropriate follow-up for anti-romosozumab antibody formation and adverse events. The primary analysis will be performed after all subjects have had the opportunity to complete the Month 6 visit. The final analysis will be performed after all subjects have had the opportunity to complete the Month 9 visit.
| Arm | Type | Receives |
|---|---|---|
| Romosozumab 210 mg QM: PFS | Active comparator | Drug: romosozumab HCP administration with PFSDuring the open-label treatment period, participants receive 210 mg romosozumab SC QM by HCP administration with PFS. |
| Romosozumab 210 mg QM: AI/Pen | Active comparator | Device: romosozumab self-administration with AI/PenDuring the open-label treatment period, participants receive 210 mg romosozumab SC QM by self-administration with AI/pen. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject has provided informed consent/assent prior to initiation of any studyspecific activities/procedures, or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
- Postmenopausal female (postmenopausal status is defined as no vaginal bleeding or spotting for 12 consecutive months prior to screening)
- -≥ 55 to ≤ 90 years of age at the time of informed consent
- Ambulatory
- BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans -Subject has at least 2 vertebrae in the L1-L4 region evaluable by DXA, as assessed by the principal investigator or designee
Key exclusion criteria (7 listed)
- History of osteonecrosis of the jaw and/or atypical femoral fracture
- History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
- Subject with reported history of hearing loss associated with cranial nerve VIII compression due to excessive bone growth (eg, as seen in conditions such as Paget's disease, sclerosteosis and osteopetrosis)
- Vitamin D insufficiency [defined as serum 25 (OH) vitamin D levels < 20 ng/mL], as determined by the central laboratory. Vitamin D repletion will be permitted a nd subjects may be rescreened
- Current hyperthyroidism (unless well controlled on stable antithyroid therapy) by subject report or by chart review, per principal investigator evaluation
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 |
|---|---|---|
| romosozumab HCP administration with PFSAlso: Evenity, AMG785210 mg romosozumab SC QM by HCP administration with 2 PFS | Drug | Romosozumab 210 mg QM: PFS |
| romosozumab self-administration with AI/PenAlso: Evenity, AMG785210 mg romosozumab SC QM by self-administration with 2 AI/Pens | Device | Romosozumab 210 mg QM: AI/Pen |
Primary outcome
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Time frame: Baseline, Month 6
Percent change from baseline in BMD at the lumbar spine as measured by dual-energy x-ray absorptiometry (DXA).
4 secondary outcomes
Percent Change From Baseline in Total Hip BMD at Month 6
Time frame: Baseline, Month 6
Percent Change From Baseline in Femoral Neck BMD at Month 6
Time frame: Baseline, Month 6
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths
Time frame: up to Month 9 (-7/+3 days)
Number of Participants Developing Anti-Romosozumab Antibodies
Time frame: up to Month 9 (-7/+3 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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
46 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing romosozumab HCP administration with PFS and romosozumab self-administration with AI/Pen in people with Post-Menopausal Osteoporosis, run by Amgen at 46 sites in 3 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 14 inclusion and 7 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 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, United Kingdom, 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 10 Apr 2020). 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 6 (time frame: Baseline, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2020.