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Denosumab, Raloxifene, and Zoledronic Acid for the Treatment of Postmenopausal Osteoporosis: Clinical Effectiveness and Harms

Rapid Response Report: Systematic Review

, BPharm, MBA, , MD, MSc, , BSc Phm, MPH, , BA(Hons), MISt, , PhD, , MSc, PhD, and , MD, FRCPC, FACP, FACE.

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Excerpt

Osteoporosis is a skeletal disorder characterized by compromised bone strength, predisposing patients to an increased risk of fracture. The postmenopausal form of osteoporosis affects more than 1.5 million Canadians, with prevalence increasing from 6% of women aged 50 to 59 years to more than 40% of women aged 80 years and older. Consequences of sustaining a fracture may be serious and include increased risk of subsequent fractures, hospitalization or institutionalization, decreased quality of life, and premature mortality, with a related burden on the health care system. Antiresorptive agents such as oral bisphosphonates are the standard treatment for postmenopausal osteoporosis, in conjunction with non-pharmacologic measures. Other treatment options include an intravenous bisphosphonate (zoledronic acid), a monoclonal antibody (denosumab), a bone-forming agent (teriparatide), and a selective estrogen receptor modulator (raloxifene). This systematic review was undertaken following a request from provincial drug formularies to evaluate the clinical effectiveness and harms of three of these agents, denosumab, raloxifene, and zoledronic acid, in postmenopausal women with osteoporosis. The evidence gathered is expected to clarify uncertainty regarding these agents and to inform policy-making in the population of interest.

Contents

Health technology assessment agencies face the challenge of providing quality assessments of medical technologies in a timely manner to support decision-making. Ideally, all important deliberations would be supported by comprehensive health technology assessment reports, but the urgency of some decisions often requires a more immediate response.

The Rapid Response Service provides Canadian health care decision-makers with health technology assessment information, based on the best available evidence, in a quick and efficient manner. Inquiries related to the assessment of health care technologies (drugs, devices, diagnostic tests, and surgical procedures) are accepted by the service. Information provided by Rapid Response Service is tailored to meet the needs of decision-makers, taking into account the urgency, importance, and potential impact of the request.

Consultations with the requestor of this Rapid Response assessment indicated that a review of the literature would be beneficial. The research question and selection criteria were developed in consultation with the requestor. The literature search was carried out by an information specialist using a standardized search strategy. The review of evidence was conducted by one internal reviewer. The draft report was internally reviewed and externally peer-reviewed by two or more peer reviewers. All comments were reviewed internally to ensure that they were addressed appropriately.

CADTH is funded by Canadian federal, provincial, and territorial governments.

Suggested citation:

Gauthier K, Bai A, Perras C, Cunningham J, Ahuja,T, Richter, T, Kovacs, C. Denosumab, Raloxifene, and Zoledronic Acid for the Treatment of Postmenopausal Osteoporosis: Clinical Effectiveness and Harms [Internet]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2012 (Rapid Response Report: Systematic Review).

Production of this report 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, Prince Edward Island, Saskatchewan, and Yukon. The Canadian Agency for Drugs and Technologies in Health takes sole responsibility for the final form and content of this report. The views expressed herein do not necessarily represent the views of Health Canada, or any provincial or territorial government.

Disclaimer: This report was prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). CADTH is an independent, not-for-profit organization funded by the federal, provincial, and territorial governments of Canada. CADTH is one of Canada’s leading sources of information and advice about the effectiveness and efficiency of drugs, medical devices, and other health technologies. The report contains a comprehensive review of the existing public literature, studies, materials, and other information and documentation (collectively the —source documentation) available to CADTH at the time of report preparation, and was guided by expert input and advice throughout its preparation. The information in this report is intended to help 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 within the Canadian health care systems. The information in this report should not be used as a substitute for the application of clinical judgment in 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. CADTH takes sole responsibility for the final form and content of this report subject to the limitations noted above. The statements, conclusions, and views expressed herein do not necessarily represent the view of Health Canada or any Canadian provincial or territorial government. Production of this report is made possible by financial contributions from Health Canada and the governments of Alberta, British Columbia, Manitoba, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Prince Edward Island, Saskatchewan and Yukon.

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.

Links: This document may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third-party sites is governed by the owners’ own terms and conditions set out for such sites. CADTH does not make any guarantee with respect to any information contained on such third-party sites and CADTH is not responsible for any injury, loss, or damage suffered as a result of using such third-party sites.

Copyright © CADTH (February 2012)

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/

Bookshelf ID: NBK169524PMID: 24278999

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