Search

Osteoporosis, literally “porous bone”, is a disease characterized by weak bone. It is a major public health problem, affecting hundreds of millions of people worldwide, predominantly postmenopausal women. The main clinical consequence of the disease is bone fractures. It is estimated that one in three women and one in five men over the age of fifty worldwide will sustain an osteoporotic fracture. Hip and spine fractures are the two most serious fracture types, associated with substantial pain and suffering, disability, and even death. As a result, osteoporosis imposes a significant burden on both the individual and society. During the past two decades, a range of medications has become available for the treatment and prevention of osteoporosis. The primary aim of pharmacological therapy is to reduce the risk of osteoporotic fractures. The objective of this report is to review and describe the current burden of osteoporosis and highlight recent advances and ongoing challenges for treatment and prevention of the disease. The report encompasses both epidemiological and health economic aspects of osteoporosis and osteoporotic fractures with a primary geographic focus on France, Germany, Italy, Spain, Sweden, and the UK. Projections of the future prevalence of osteoporosis and fracture incidence, the total societal burden of the disease, and the consequences of different intervention strategies receive special attention. The report may serve as a basis for the formulation of healthcare policy concerning osteoporosis in general and the treatment and prevention of osteoporosis in particular. It may also provide guidance regarding the overall healthcare priority of the disease. The report is divided into six chapters: 1. Introduction to osteoporosis The first chapter provides a brief review of osteoporosis, how osteoporotic fractures are defined, a description of the most common osteoporotic fractures, the burden of fractures, as well as challenges in the delivery of health care to reduce the number of fractures. 2. Medical innovation and clinical progress in management of osteoporosis The second chapter reviews the measurement of bone mineral density, diagnosis of osteoporosis, methods for assessment of fracture risk, the development of interventions that reduce the risk of fractures, practice guidelines, and the cost-effectiveness of osteoporosis treatments. 3. Epidemiology of osteoporosis The third chapter reviews the epidemiology and consequences of osteoporosis and fractures, as well as different approaches for setting intervention thresholds ( i.e. at what fracture risk it is appropriate to initiate treatment ). 4. Burden of osteoporosis The fourth chapter presents a model estimation of the current burden of osteoporosis in the five largest countries in the European Union ( EU5 ) and Sweden. The burden is described in terms of fractures, costs, and quality-adjusted life years ( QALYs ) lost. 5. Uptake of osteoporosis treatments The fifth chapter provides a description of the current uptake of osteoporosis treatments, that is, how many patients of those eligible for treatment that actually can be treated in France, Germany, Italy, Spain, Sweden and the UK. International sales data from 1998 and forward was used to analyse international variations in treatment uptake. 6. The future burden of fractures and the consequences of increasing treatment uptake The last chapter presents projections of how the demographic changes in the five largest countries in the France, Germany, Italy, Spain, Sweden and the UK will impact the burden of osteoporosis up to 2025. Hypothetical projections of increments in treatment provision are also explored, and the impact of increased treatment on costs, fracture rates, and morbidity is estimated.

Assessment and intervention thresholds are developed and proposed in men aged over 50 years and postmenopausal women for the UK based on fracture probability from the WHO fracture risk assessment tool (FRAX®). The FRAX® tool has recently become available to compute the 10-year probability of fractures in men and women from clinical risk factors (CRFs) with or without the measurement of femoral neck bone mineral density (BMD). The aim of this study was to develop a case-finding strategy for men and women from the UK at high risk of osteoporotic fracture by delineating the fracture probabilities at which BMD testing or intervention should be recommended. Fracture probabilities were computed using the FRAX® tool calibrated to the epidemiology of fracture and death in the UK. The relationship between cost effectiveness and fracture probability used the source data from a prior publication that examined the cost effectiveness of generic alendronate in the UK. An intervention threshold was set by age in men and women, based on the fracture probability equivalent to that of women with a history of a prior osteoporosis related fracture. In addition, assessment thresholds for the use of BMD testing were explored. Assessment thresholds for the measurement of BMD followed current practice guidelines where individuals were considered to be eligible for assessment in the presence of one or more CRF. An upper assessment threshold (i.e. a fracture probability above which patients could be treated without recourse to BMD) was based on optimisation of the positive predictive value of the assessment tool. The consequences of assessment and intervention thresholds on the requirement for BMD test and interventions were assessed using the distribution of clinical risk factors and femoral neck BMD for women in the source cohorts used for the development of the FRAX® models Treatment was cost effective at all ages when the 10-year probability of a major fracture exceeded 7%. The intervention threshold at the age of 50 years corresponded to a 10-year probability of a major osteoporotic fracture of 7.5%. This rose progressively with age to 30% at the age of 80 years, so that intervention was cost effective at all ages. Assessment thresholds for testing with BMD (6–9% at the age of 50 years) also rose with age (18–36% at the age of 80 years). The use of these thresholds in a case-finding strategy would identify 6–20% of women as eligible for BMD testing and 23–46% as eligible for treatment, depending on age. The same threshold can be used in men. The study provides a method of developing management algorithms for osteoporosis from the estimation of fracture probabilities, rather than those based on BMD alone or BMD with single or multiple CRFs.