Using a sequential explanatory mixed method to evaluate the therapeutic window of opportunity for initiating osteoporosis treatment following fragility fractures
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Interventions targeting patients with recent fragility fracture and their physician were most successful at initiating osteoporosis treatment during the first 12 months. This window of opportunity had already closed after 1 year. The reasons for declining or accepting the intensive intervention were explored in patients still untreated at 12 months.
A fragility fracture (FF) event identifies patients most likely to benefit from osteoporosis treatment. Nonetheless, most FF patients go untreated. Our objective was to determine how long an incident FF remains a strong incentive to initiate osteoporosis treatment.
A total of 1086 men and women over age 50 with a recent FF event were assigned to either standard care (SC), to minimal (MIN), or intensive (INT) interventions targeting patients and their family physician to initiate osteoporosis treatment. Inpatients with FF (mainly hip) evaluated by rheumatologists were also included in a specialized group (SPE; n = 324). At 1 year, untreated patients in both the SC and the MIN groups were offered an INT intervention. The cohort was followed through 48 months. A qualitative analysis of patient-centered decision-making associated with initiation of treatment was conducted.
In MIN and INT groups, osteoporosis treatment was initiated in 41.0 and 54.3% of untreated patients by 12 months, respectively, compared to 68.4% in SPE and 18.9% in SC groups; initiation rates drastically dropped thereafter. Over 4863 patient-years of follow-up, the rates of new FF were 3.4 per 100 patient-years, without significant differences between patients with initial major or minor FF, nor between control or intervention groups. Failure by patients and physicians to recognize FF as a sign of underlying bone disease contributed the most to lack of treatment.
While incident FFs are an ideal opportunity for starting osteoporosis treatment, 1 year later, the therapeutic window of opportunity has already closed.
KeywordsAdherence Fragility fracture Osteoporosis Window of opportunity
We are especially indebted to our study coordinator Noémie Poirier for her continuing involvement and dedication.
Supported by unrestricted research grants from Merck Canada, Amgen Canada, The Alliance for Better Bone Health (Procter&Gamble, sanofi-aventis), Novartis Pharmaceuticals Canada Inc., Warner Chilcott Canada, Eli Lilly Canada and Servier Canada, and by the Centre de Recherche Clinique Étienne-LeBel (CRC) from the CHUS, which received a team grant from the Fonds de Recherche du Québec-Santé (FRQ-S). None of the funding sources had any role in the design of the study, collection, analysis, or interpretation of the data or in the decision to publish this article.
Compliance with ethical standards
The Ethics Review Board of the CHUS approved the study (Clinical Trials.gov ID: NCT00512499).
Conflict of interest
No disclosure except GB who has received lecture fees or advisory board fees from BMS Canada, Celgene Canada, Novartis Canada, and UCB Canada; GB and SR from Eli Lilly Canada, Amgen Canada, and Pfizer Canada; IG has received research funding from Merck Canada, and SR from BMS and Pfizer Canada.
All procedures were in accordance with the ethical standards of the CHUS institutional research committee and with TCPS 2 (2014)- the latest edition of Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.
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