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Denosumab (Prolia)

Treatment to Increase Bone Mass in Men with Osteoporosis at High Risk for Fracture; or Who Have Failed or are Intolerant to Other Available Osteoporosis Therapy

Common Drug Review

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Osteoporosis is a skeletal disorder characterized by compromised bone strength predisposing patients to an increased risk of fracture. In men, coexisting conditions and risk factors often combine with age-related, slowly proceeding bone loss to result in osteoporosis and fragility fractures. Osteoporotic fractures are a significant health care concern with devastating impacts on patients, often leading to an increased risk of subsequent fracture, hospitalization, decreased quality of life, premature mortality, and increased burden on the health care system. For men requiring treatment of osteoporosis, the Osteoporosis Canada 2010 guidelines recommend the oral bisphosphonates alendronate and risedronate, as well as the parenteral bisphosphonate zoledronic acid, as first-line treatment options.

Denosumab is a human monoclonal antibody binding to human receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab has a Health Canada indication as treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or in patients who have failed or are intolerant to other available osteoporosis therapy. The drug plans that participate in the CADTH Common Drug Review (CDR) process have requested that denosumab be evaluated for reimbursement for treating osteoporosis in men according to the Health Canada indication. The objective of this report was to perform a systematic review of the beneficial and harmful effects of denosumab as a treatment to increase bone mass in men with osteoporosis at high risk for fracture, or who have failed or are intolerant to other available osteoporosis therapy.


This review report was prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). In addition to CADTH staff, the review team included a clinical expert in rheumatology who provided input on the conduct of the review and the interpretation of findings.

Through the CADTH Common Drug Review (CDR) process, CADTH undertakes reviews of drug submissions, resubmissions, and requests for advice, and provides formulary listing recommendations to all Canadian publicly funded federal, provincial, and territorial drug plans, with the exception of Quebec.

The report contains an evidence-based clinical and/or pharmacoeconomic drug review, based on published and unpublished material, including manufacturer submissions; studies identified through independent, systematic literature searches; and patient group submissions. In accordance with CDR Update — Issue 87, manufacturers may request that confidential information be redacted from CDR Clinical and Pharmacoeconomic Review Reports.

The information in this report is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. The information in this report should not be used as a substitute for the application of clinical judgment with respect to the care of a particular patient or other professional judgment in any decision-making process, nor is it intended to replace professional medical advice. While CADTH has taken care in the preparation of this document to ensure that its contents are accurate, complete, and up-to-date as of the date of publication, CADTH does not make any guarantee to that effect. CADTH is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in the source documentation. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the information in this document or in any of the source documentation.

This document is intended for use in the context of the Canadian health care system. Other health care systems are different; the issues and information related to the subject matter of this document may be different in other jurisdictions and if used outside of Canada, it is at the user’s risk. This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada.

CADTH takes sole responsibility for the final form and content of this document, subject to the limitations noted above. The statements and conclusions in this document are those of CADTH and not of its advisory committees and reviewers. The statements, conclusions, and views expressed herein do not necessarily represent the views of Health Canada or any Canadian provincial or territorial government. Production of this document is made possible by financial contributions from Health Canada and the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Saskatchewan, and Yukon.

Copyright © CADTH 2015.

You are permitted to make copies of this document for non-commercial purposes, provided it is not modified when reproduced and appropriate credit is given to CADTH. You may not otherwise copy, modify, translate, post on a website, store electronically, republish, or redistribute any material from this document in any form or by any means without the prior written permission of CADTH.

Please contact CADTH’s Vice-President of Corporate Services at ac.htdac@secivresetaroproc with any inquiries about this notice or other legal matters relating to CADTH’s services.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

PMID: 26962604


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