Suzanne Cadarette

Timely administration of denosumab every 6 mo is critical in osteoporosis treatment to avoid multiple vertebral fracture risk upon denosumab discontinuation or delay. This study aimed to estimate the immediate and prolonged impact of the COVID-19 pandemic on the timing of denosumab doses. We identified older adults (≥66 yr) residing in the community who were due to receive denosumab between January 2016 and December 2020 using Ontario Drug Benefit data. We completed an interrupted time-series analysis to estimate the impact of the COVID-19 pandemic (March 2020) on the monthly proportion of on-time denosumab doses (183 +/-30 d)...

Observational studies of osteoporosis medications can provide critical real-world evidence (RWE) that fills knowledge gaps left by clinical trials. However, careful consideration of study design is needed to yield reliable estimates of association. In particular, obtaining valid measurements of exposure to osteoporosis medications from real-world data (RWD) sources is complicated due to different medication classes, formulations, and routes of administration, each with different pharmacology. Extended half-lives of bisphosphonates and extended dosing of denosumab and zoledronic acid require particular attention...

No abstract text is available yet for this article.

BACKGROUND: In Canada, more than 2 million people live with osteoporosis, a disease that increases the risk for fractures, which result in excess mortality and morbidity, decreased quality of life and loss of autonomy. This guideline update is intended to assist Canadian health care professionals in the delivery of care to optimize skeletal health and prevent fractures in postmenopausal females and in males aged 50 years and older. METHODS: This guideline is an update of the 2010 Osteoporosis Canada clinical practice guideline on the diagnosis and management of osteoporosis in Canada...

BACKGROUND: Traditionally, much of community pharmacy practice relies on patients to request their own medication refills. These refills are often not aligned, which has been shown to decrease adherence and workflow efficiencies. The appointment-based model (ABM) is designed to proactively synchronize refills and schedule patient-pharmacist appointments. OBJECTIVES: To describe the characteristics of patients enrolled in the ABM; and to compare the number of distinct refill dates, number of refills, and adherence for antihypertensives, oral antihyperglycemics, and statins 6-months and 12-months pre-post ABM implementation...

We identified inconsistency in fracture definitions in a prior review of studies that utilized claims data. Here, we aimed to compare fracture rates estimated using thirteen hip and seven radius/ulna fracture definitions. Our primary analysis compared results in a cohort of 120,363 older adults treated with oral bisphosphonates for ≥3 years. The most inclusive definition (hip: inpatient or emergency diagnosis; radius/ulna: inpatient, emergency, or outpatient diagnosis) served as a referent to compare the number and proportion of fractures captured...

No abstract text is available yet for this article.

No abstract text is available yet for this article.

BACKGROUND: An osteoporosis drug holiday is recommended for most patients after 3 to 5 years of therapy. Risedronate has a shorter half-life than alendronate, and thus the residual length of fracture protection may be shorter. OBJECTIVE: To examine the comparative risks of drug holidays after long-term (≥3 years) risedronate versus alendronate therapy. DESIGN: Population-based, matched, cohort study. SETTING: Province-wide health care administrative databases providing comprehensive coverage to Ontario residents aged 65 years or older between November 2000 and March 2020...

OBJECTIVE: The objective of this review is to describe fracture outcome definitions in observational osteoporosis drug effects studies from Canada and the United States of America. INTRODUCTION: Health care administrative data are commonly utilized in pharmacoepidemiologic studies. These data are used to define outcomes, such as fractures, and are critical to determining real-world safety and effectiveness of medications. However, there is no current standard for fracture outcome definitions in observational studies...

No abstract text is available yet for this article.

No abstract text is available yet for this article.

OBJECTIVE: The objective of this review is to summarize observational research methods employed to study fracture risk and the use of type 2 diabetes mellitus medications. The methods summary will be used as a case study to illustrate current practices in the study of medication effects on fracture risk. INTRODUCTION: Observational studies examining drug effects on fracture risk fill knowledge gaps left by clinical trials but require specific design considerations...

For self-controlled studies of medication-related effects, time-varying confounding by indication may occur if the indication varies over time. We describe how active comparators might mitigate such bias, using an empirical example. Approaches to using active comparators are described for case-crossover design, case-time-control design, self-controlled case-series and sequence symmetry analyses. In the empirical example, we used Danish data 1996-2018 to study the association between penicillin and venous thromboembolism (VTE), using roxithromycin, a macrolide antibiotic, as comparator...

Bisphosphonates are first-line therapy for osteoporosis, with alendronate, risedronate, and zoledronate as the main treatments used globally. After one year of therapy, bisphosphonates are retained in bone for extended periods with extended anti-fracture effects after discontinuation. Due to this continued fracture protection and the potential for rare adverse events associated with long-term use (atypical femoral fractures and osteonecrosis of the jaw), a drug holiday of two to three years is recommended for most patients after long-term bisphosphonate therapy...

OBJECTIVE: This scoping review aims to compare strategies for measuring prescription medication switching with pharmacy claims data, with a focus on psychotropic vs non-psychotropic medications. INTRODUCTION: Medication switching (ie, the replacement of one medication for another) is common and occurs due to several factors (such as adverse effects to a specific medication). In pharmacoepidemiology studies that use pharmacy claims data, it is important to identify and account for switches; however, due to data limitations and lack of a methodological standard, this can be challenging...

PURPOSE: Consensus is needed on conceptual foundations, terminology and relationships among the various self-controlled "trigger" study designs that control for time-invariant confounding factors and target the association between transient exposures (potential triggers) and abrupt outcomes. The International Society for Pharmacoepidemiology (ISPE) funded a working group of ISPE members to develop guidance material for the application and reporting of self-controlled study designs, similar to Standards of Reporting Observational Epidemiology (STROBE)...

BACKGROUND: Several clinical prediction rules (CPRs) for complications and mortality of Clostridioides difficile infection (CDI) have been developed but only a few have gone through external validation, and none is widely recommended in clinical practice. METHODS: CPRs were identified through a systematic review. We included studies that predicted severe or complicated CDI (cCDI) and mortality, reported at least an internal validation step, and for which data were available with minimal modifications...

The purpose of this paper is to help readers choose an appropriate observational study design for measuring an association between an exposure and disease incidence. We discuss cohort studies, sub-samples from cohorts (case-cohort and nested case-control designs), and population-based or hospital-based case-control studies. Appropriate study design is the foundation of a scientifically valid observational study. Mistakes in design are often irremediable. Key steps are understanding the scientific aims of the study and what is required to achieve them...

Adverse events related to long-term use of bisphosphonates have raised interest in temporary drug discontinuation. Trends in bisphosphonate discontinuation and restart, as well factors associated with these decisions are not fully understood at a population level. We investigated temporal trends of bisphosphonate discontinuation from 2010 to 2015, and identified factors associated with discontinuation and restart of osteoporosis therapy. Our cohort consisted of long-term bisphosphonate users identified from 2010-2015 Medicare data...