A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis

November 5, 2020 updated by: Amgen

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
283

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bialystok, Poland, 15-351
        • Research Site
      • Lodz, Poland, 90-558
        • Research Site
      • Swidnik, Poland, 21-040
        • Research Site
      • Warszawa, Poland, 01-192
        • Research Site
  • United Kingdom
      • Chorley, United Kingdom, PR7 7NA
        • Research Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Research Site
      • Liverpool, United Kingdom, L22 0LG
        • Research Site
      • London, United Kingdom, DA14 6LT
        • Research Site
      • Manchester, United Kingdom, M15 6SX
        • Research Site
      • Northwood, United Kingdom, HA6 2RN
        • Research Site
      • Romford, United Kingdom, RM1 3PJ
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
      • Birmingham, Alabama, United States, 35205
        • Research Site
      • Huntsville, Alabama, United States, 35801
        • Research Site
      • Tuscaloosa, Alabama, United States, 35406
        • Research Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Research Site
      • Mesa, Arizona, United States, 85213
        • Research Site
    • California
      • Cypress, California, United States, 90630
        • Research Site
      • Fullerton, California, United States, 92835
        • Research Site
      • Glendale, California, United States, 91206
        • Research Site
      • Laguna Hills, California, United States, 92653
        • Research Site
      • Santa Maria, California, United States, 93454
        • Research Site
      • Tustin, California, United States, 92780
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80230
        • Research Site
      • Golden, Colorado, United States, 80401
        • Research Site
    • Florida
      • Delray Beach, Florida, United States, 33446
        • Research Site
      • South Miami, Florida, United States, 33143
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Research Site
      • Atlanta, Georgia, United States, 30319
        • Research Site
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Research Site
      • Springfield, Missouri, United States, 65802
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Research Site
    • New York
      • Great Neck, New York, United States, 11021
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
      • Wyomissing, Pennsylvania, United States, 19610
        • Research Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Research Site
      • Summerville, South Carolina, United States, 29486
        • Research Site
    • Texas
      • San Antonio, Texas, United States, 78209
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Research Site
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Research Site
      • Danville, Virginia, United States, 24541
        • Research Site
    • Washington
      • Renton, Washington, United States, 98057
        • Research Site
    • Wisconsin
      • Franklin, Wisconsin, United States, 53132
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Romosozumab 210 mg QM: PFS
During the open-label treatment period, participants receive 210 mg romosozumab SC QM by HCP administration with PFS.
Drug: romosozumab HCP administration with PFS
210 mg romosozumab SC QM by HCP administration with 2 PFS
Other Names:
  • Evenity
  • AMG785
ACTIVE_COMPARATOR: Romosozumab 210 mg QM: AI/Pen
During the open-label treatment period, participants receive 210 mg romosozumab SC QM by self-administration with AI/pen.
Device: romosozumab self-administration with AI/Pen
210 mg romosozumab SC QM by self-administration with 2 AI/Pens
Other Names:
  • Evenity
  • AMG785

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline, Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Total Hip BMD at Month 6
Time Frame: Baseline, Month 6
Percent change from baseline in BMD for total hip as measured by DXA.
Baseline, Month 6
Percent Change From Baseline in Femoral Neck BMD at Month 6
Time Frame: Baseline, Month 6
Percent change from baseline in BMD at femoral neck as measured by DXA.
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)
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.
up to Month 9 (-7/+3 days)
Number of Participants Developing Anti-Romosozumab Antibodies
Time Frame: up to Month 9 (-7/+3 days)
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.
up to Month 9 (-7/+3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20150120
  • 2017-003512-40 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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