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NCT03432533

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

Last Updated: 2020-11-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-06

Study Completion Date

2020-01-08

Brief Summary

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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)

Detailed Description

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Conditions

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Post-Menopausal Osteoporosis

Keywords

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Post-Menopausal osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label study; blinding procedures are not applicable.

Study Groups

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Romosozumab 210 mg QM: PFS

During the open-label treatment period, participants receive 210 mg romosozumab SC QM by HCP administration with PFS.

Group Type ACTIVE_COMPARATOR

romosozumab HCP administration with PFS

Intervention Type DRUG

210 mg romosozumab SC QM by HCP administration with 2 PFS

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.

Group Type ACTIVE_COMPARATOR

romosozumab self-administration with AI/Pen

Intervention Type DEVICE

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

Interventions

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romosozumab HCP administration with PFS

210 mg romosozumab SC QM by HCP administration with 2 PFS

Intervention Type DRUG

romosozumab self-administration with AI/Pen

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

Intervention Type DEVICE

Other Intervention Names

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Evenity AMG785 Evenity AMG785

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-003512-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20150120

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Romosozumab 210 mg QM: PFS

romosozumab HCP administration with PFS

Romosozumab 210 mg QM: AI/Pen

romosozumab self-administration with AI/Pen

Interventions

romosozumab HCP administration with PFS

romosozumab self-administration with AI/Pen

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Amgen

Responsible Party

Principal Investigators

MD

Locations

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Countries

Provided Documents

Document Type: Study Protocol

Document Type: Statistical Analysis Plan

Related Links

Other Identifiers

2017-003512-40

20150120