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

Post-Menopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432533
• Other study ID #: 20150120
• Secondary ID: 2017-003512-40
• Status: Completed
• Phase: Phase 3
• Start date: February 6, 2018
• Est. completion date: January 8, 2020

Study information

• Verified date: October 2020
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (AI/Pen)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: January 8, 2020
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post-Menopausal Osteoporosis

Intervention

Drug:
• romosozumab HCP administration with PFS
210 mg romosozumab SC QM by HCP administration with 2 PFS

Device:
• romosozumab self-administration with AI/Pen
210 mg romosozumab SC QM by self-administration with 2 AI/Pens

Locations

Country	Name	City	State
Poland	Research Site	Bialystok
Poland	Research Site	Lodz
Poland	Research Site	Swidnik
Poland	Research Site	Warszawa
United Kingdom	Research Site	Chorley
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Northwood
United Kingdom	Research Site	Romford
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Birmingham	Alabama
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bridgeton	Missouri
United States	Research Site	Chandler	Arizona
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chesapeake	Virginia
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cypress	California
United States	Research Site	Danville	Virginia
United States	Research Site	Delray Beach	Florida
United States	Research Site	Denver	Colorado
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Fargo	North Dakota
United States	Research Site	Franklin	Wisconsin
United States	Research Site	Fullerton	California
United States	Research Site	Glendale	California
United States	Research Site	Golden	Colorado
United States	Research Site	Great Neck	New York
United States	Research Site	Huntsville	Alabama
United States	Research Site	Laguna Hills	California
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Mesa	Arizona
United States	Research Site	Renton	Washington
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	Santa Maria	California
United States	Research Site	South Miami	Florida
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Springfield	Missouri
United States	Research Site	Summerville	South Carolina
United States	Research Site	Tuscaloosa	Alabama
United States	Research Site	Tustin	California
United States	Research Site	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent Change From Baseline in Total Hip BMD at Month 6	Percent change from baseline in BMD for total hip as measured by DXA.	Baseline, Month 6
Secondary	Percent Change From Baseline in Femoral Neck BMD at Month 6	Percent change from baseline in BMD at femoral neck as measured by DXA.	Baseline, Month 6
Secondary	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.	up to Month 9 (-7/+3 days)
Secondary	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.	up to Month 9 (-7/+3 days)

External Links

•   AmgenTrials clinical trials website