The Effects of Noncompliance to Prolia (Denosumab) on the Changes in Bone Mineral Density: A Retrospective Review

Although denosumab (Prolia) has been shown to be a safe and efficacious therapy for osteoporotic patients in numerous clinical trials, few studies have determined its effectiveness in real world clinical practice. A retrospective review of patients prescribed Prolia assessing the impact that noncomp...

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Main Authors: Matthew Wong-Pack, Aashish Kalani, Jacob Hordyk, George Ioannidis, Robert Bensen, William G. Bensen, Alexandra Papaioannou, Jonathan D. Adachi, Arthur N. Lau
Format: Article
Language:English
Published: Wiley 2016-01-01
Series:Journal of Osteoporosis
Online Access:http://dx.doi.org/10.1155/2016/7903128
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author Matthew Wong-Pack
Aashish Kalani
Jacob Hordyk
George Ioannidis
Robert Bensen
William G. Bensen
Alexandra Papaioannou
Jonathan D. Adachi
Arthur N. Lau
author_facet Matthew Wong-Pack
Aashish Kalani
Jacob Hordyk
George Ioannidis
Robert Bensen
William G. Bensen
Alexandra Papaioannou
Jonathan D. Adachi
Arthur N. Lau
author_sort Matthew Wong-Pack
collection DOAJ
description Although denosumab (Prolia) has been shown to be a safe and efficacious therapy for osteoporotic patients in numerous clinical trials, few studies have determined its effectiveness in real world clinical practice. A retrospective review of patients prescribed Prolia assessing the impact that noncompliance from the regular dosing regimen of six months for denosumab has on bone mineral density (BMD) was performed. 924 patient records were reviewed between August 2012 and September 2013 with 436 patients meeting the eligibility criteria. Patients were divided into three groups: subsequent injection of denosumab (1) less than five months, (2) between five and seven months, and (3) more than seven months after their initial subcutaneous injection. A multivariable regression analysis was conducted comparing the differences among the three prespecified groups in BMD change (g/cm2) after one year of denosumab therapy at both the lumbar spine (LS) and femoral neck (FN). The differences in LS and FN BMD have shown that the relationship between the timing of drug administration in these three groups and change in BMD over 1 year was not clinically or statistically significant (p>0.05). A follow-up study with a larger sample size and longer follow-up duration is required to further characterize this relationship.
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spelling doaj-art-f7124234f05d49c8a7f1859c25d58e682025-02-03T07:24:54ZengWileyJournal of Osteoporosis2090-80592042-00642016-01-01201610.1155/2016/79031287903128The Effects of Noncompliance to Prolia (Denosumab) on the Changes in Bone Mineral Density: A Retrospective ReviewMatthew Wong-Pack0Aashish Kalani1Jacob Hordyk2George Ioannidis3Robert Bensen4William G. Bensen5Alexandra Papaioannou6Jonathan D. Adachi7Arthur N. Lau8Faculty of Health Sciences, McMaster University, 501-25 Charlton Avenue E., Hamilton, ON, L8N 1Y2, CanadaFaculty of Health Sciences, McMaster University, 501-25 Charlton Avenue E., Hamilton, ON, L8N 1Y2, CanadaUniversity of Ottawa, 75 Laurier Avenue E., Ottawa, ON, K1N 6N5, CanadaDivision of Rheumatology, Department of Medicine, McMaster University, 501-25 Charlton Avenue E., Hamilton, ON, L8N 1Y2, CanadaRheumatology Health Team, St. Joseph’s Hospital, 203-25 Charlton Avenue E., Hamilton, ON, L8N 1Y2, CanadaRheumatology Health Team, St. Joseph’s Hospital, 203-25 Charlton Avenue E., Hamilton, ON, L8N 1Y2, CanadaDivision of Geriatrics, Department of Medicine, McMaster University, St. Peter’s Hospital, HHS 88 Maplewood Avenue, Hamilton, ON, L8M 1W9, CanadaDivision of Rheumatology, Department of Medicine, McMaster University, 501-25 Charlton Avenue E., Hamilton, ON, L8N 1Y2, CanadaDivision of Rheumatology, Department of Medicine, McMaster University, 501-25 Charlton Avenue E., Hamilton, ON, L8N 1Y2, CanadaAlthough denosumab (Prolia) has been shown to be a safe and efficacious therapy for osteoporotic patients in numerous clinical trials, few studies have determined its effectiveness in real world clinical practice. A retrospective review of patients prescribed Prolia assessing the impact that noncompliance from the regular dosing regimen of six months for denosumab has on bone mineral density (BMD) was performed. 924 patient records were reviewed between August 2012 and September 2013 with 436 patients meeting the eligibility criteria. Patients were divided into three groups: subsequent injection of denosumab (1) less than five months, (2) between five and seven months, and (3) more than seven months after their initial subcutaneous injection. A multivariable regression analysis was conducted comparing the differences among the three prespecified groups in BMD change (g/cm2) after one year of denosumab therapy at both the lumbar spine (LS) and femoral neck (FN). The differences in LS and FN BMD have shown that the relationship between the timing of drug administration in these three groups and change in BMD over 1 year was not clinically or statistically significant (p>0.05). A follow-up study with a larger sample size and longer follow-up duration is required to further characterize this relationship.http://dx.doi.org/10.1155/2016/7903128
spellingShingle Matthew Wong-Pack
Aashish Kalani
Jacob Hordyk
George Ioannidis
Robert Bensen
William G. Bensen
Alexandra Papaioannou
Jonathan D. Adachi
Arthur N. Lau
The Effects of Noncompliance to Prolia (Denosumab) on the Changes in Bone Mineral Density: A Retrospective Review
Journal of Osteoporosis
title The Effects of Noncompliance to Prolia (Denosumab) on the Changes in Bone Mineral Density: A Retrospective Review
title_full The Effects of Noncompliance to Prolia (Denosumab) on the Changes in Bone Mineral Density: A Retrospective Review
title_fullStr The Effects of Noncompliance to Prolia (Denosumab) on the Changes in Bone Mineral Density: A Retrospective Review
title_full_unstemmed The Effects of Noncompliance to Prolia (Denosumab) on the Changes in Bone Mineral Density: A Retrospective Review
title_short The Effects of Noncompliance to Prolia (Denosumab) on the Changes in Bone Mineral Density: A Retrospective Review
title_sort effects of noncompliance to prolia denosumab on the changes in bone mineral density a retrospective review
url http://dx.doi.org/10.1155/2016/7903128
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