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

NCT03432533 | Completed Phase 3 Results FDA Drug FDA Device

• 2 other identifiers: 201501202017-003512-40
• Study Type: interventional
• Target: 283
• Locations: 3 countries
• Sites: 46

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)

Conditions

Post-Menopausal Osteoporosis

Keywords

Post-Menopausal osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, Month 6

Secondary Outcomes (4)

• Percent Change From Baseline in Total Hip BMD at Month 6

  Baseline, Month 6

• Percent Change From Baseline in Femoral Neck BMD at Month 6

  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

  up to Month 9 (-7/+3 days)

• Number of Participants Developing Anti-Romosozumab Antibodies

  up to Month 9 (-7/+3 days)

Study Arms (2)

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.

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.

Device: romosozumab self-administration with AI/Pen

Interventions

romosozumab HCP administration with PFS DRUG

210 mg romosozumab SC QM by HCP administration with 2 PFS

Also known as: Evenity, AMG785

Romosozumab 210 mg QM: PFS

romosozumab self-administration with AI/Pen DEVICE

210 mg romosozumab SC QM by self-administration with 2 AI/Pens

Also known as: Evenity, AMG785

Romosozumab 210 mg QM: AI/Pen

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (46)

Research Site

Birmingham, Alabama, 35205, United States

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Birmingham, Alabama, 35294, United States

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Huntsville, Alabama, 35801, United States

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Tuscaloosa, Alabama, 35406, United States

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Chandler, Arizona, 85224, United States

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Mesa, Arizona, 85213, United States

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Cypress, California, 90630, United States

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Fullerton, California, 92835, United States

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Glendale, California, 91206, United States

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Laguna Hills, California, 92653, United States

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Santa Maria, California, 93454, United States

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Tustin, California, 92780, United States

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Denver, Colorado, 80230, United States

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Golden, Colorado, 80401, United States

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Delray Beach, Florida, 33446, United States

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South Miami, Florida, 33143, United States

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Atlanta, Georgia, 30319, United States

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Atlanta, Georgia, 30342, United States

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Bridgeton, Missouri, 63044, United States

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Springfield, Missouri, 65802, United States

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Las Vegas, Nevada, 89148, United States

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Great Neck, New York, 11021, United States

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Charlotte, North Carolina, 28204, United States

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Fargo, North Dakota, 58103, United States

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Cincinnati, Ohio, 45242, United States

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Duncansville, Pennsylvania, 16635, United States

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Wyomissing, Pennsylvania, 19610, United States

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Spartanburg, South Carolina, 29303, United States

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Summerville, South Carolina, 29486, United States

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San Antonio, Texas, 78209, United States

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Salt Lake City, Utah, 84107, United States

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Chesapeake, Virginia, 23320, United States

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Danville, Virginia, 24541, United States

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Renton, Washington, 98057, United States

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Franklin, Wisconsin, 53132, United States

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Bialystok, 15-351, Poland

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Lodz, 90-558, Poland

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Świdnik, 21-040, Poland

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Warsaw, 01-192, Poland

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Chorley, PR7 7NA, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Liverpool, L22 0LG, United Kingdom

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London, DA14 6LT, United Kingdom

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Manchester, M15 6SX, United Kingdom

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Northwood, HA6 2RN, United Kingdom

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Romford, RM1 3PJ, United Kingdom

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Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

romosozumab

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; blinding procedures are not applicable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 14, 2018
• Study Start: February 6, 2018
• Primary Completion: April 11, 2019
• Study Completion: January 8, 2020
• Last Updated: November 23, 2020
• Results First Posted: April 10, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (35); GB (7); PL (4)