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Trial record 1 of 1 for:    20150120
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A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis

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ClinicalTrials.gov Identifier: NCT03432533
Recruitment Status : Completed
First Posted : February 14, 2018
Results First Posted : April 10, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief 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 (AI/Pen)

Condition or disease Intervention/treatment Phase
Post-Menopausal Osteoporosis Drug: romosozumab HCP administration with PFS Device: romosozumab self-administration with AI/Pen Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Masking Description: This is an open-label study; blinding procedures are not applicable.
Primary Purpose: Treatment
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
Actual Study Start Date : February 6, 2018
Actual Primary Completion Date : April 11, 2019
Actual Study Completion Date : January 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432533


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35205
Research Site
Birmingham, Alabama, United States, 35294
Research Site
Huntsville, Alabama, United States, 35801
Research Site
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
Research Site
Chandler, Arizona, United States, 85224
Research Site
Mesa, Arizona, United States, 85213
United States, California
Research Site
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
United States, Colorado
Research Site
Denver, Colorado, United States, 80230
Research Site
Golden, Colorado, United States, 80401
United States, Florida
Research Site
Delray Beach, Florida, United States, 33446
Research Site
South Miami, Florida, United States, 33143
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30319
Research Site
Atlanta, Georgia, United States, 30342
United States, Missouri
Research Site
Bridgeton, Missouri, United States, 63044
Research Site
Springfield, Missouri, United States, 65802
United States, Nevada
Research Site
Las Vegas, Nevada, United States, 89148
United States, New York
Research Site
Great Neck, New York, United States, 11021
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28204
United States, North Dakota
Research Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
Research Site
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Research Site
Spartanburg, South Carolina, United States, 29303
Research Site
Summerville, South Carolina, United States, 29486
United States, Texas
Research Site
San Antonio, Texas, United States, 78209
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Research Site
Chesapeake, Virginia, United States, 23320
Research Site
Danville, Virginia, United States, 24541
United States, Washington
Research Site
Renton, Washington, United States, 98057
United States, Wisconsin
Research Site
Franklin, Wisconsin, United States, 53132
Poland
Research Site
Bialystok, Poland, 15-351
Research Site
Lodz, Poland, 90-558
Research Site
Swidnik, Poland, 21-040
Research Site
Warszawa, Poland, 01-192
United Kingdom
Research Site
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
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] August 10, 2017
Statistical Analysis Plan  [PDF] May 8, 2019

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03432533    
Other Study ID Numbers: 20150120
2017-003512-40 ( EudraCT Number )
First Posted: February 14, 2018    Key Record Dates
Results First Posted: April 10, 2020
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Amgen:
Post-Menopausal osteoporosis
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs