It is defined as a disease of the skeletal system, characterized by low bone mineral density (BMD) and microarchitectural deterioration of bone tissue that can lead to enhanced bone fragility and a consequent increase in fracture risk. In the U.S., 54% of postmenopausal white women are os-teopenic and 30% are osteoporotic. A 50-year-old white woman has a 40% lifetime probability of a hip, spine, or forearm fracture. The estimated one-year direct and indirect costs of osteoporosis for those 45 years of age and older are $14 billion. Costs are primarily driven by hospitalizations related to fractures resulting from osteoporosis; costs range from $15,500 for any osteoporosis-related hospitalization to $17,383 for an osteoporosis fracture-related admission.

In the absence of a fragility fracture, a diagnosis of osteoporosis can be made with a measurement of BMD. The expression of BMD, compared with the reference mean, is known as the T-score. According to World Health Organization (WHO) guidelines, osteoporosis is indicated by BMD that is 2.5 standard deviations (SDs) or more below the reference mean for a young adult female. Thus, osteoporosis would be defined as a T-score of -2.5 or below (e.g., – 3.0). A T-score above -2.5 (e.g., -1.0) would not be defined as osteoporosis in the absence of a fragility fracture.
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Although low BMD is an important diagnostic criterion for osteoporosis, it is also an independent risk factor for fracture. Additional independent risk factors include low weight or low body mass index (BMI), advancing age, corticosteroid use, a history of fractures, a family history of hip fractures, and secondary osteoporosis associated with disorders such as rheumatoid arthritis (Table 1). Lifestyle factors, including current smoking, excessive alcohol consumption of more than 2 units (approximately two drinks of alcohol) per day, have also been independently associated with osteoporotic fractures.

Table 1 Increase in Hip Fracture Risk by Risk Factor

Risk Factor                    Increase in Risk* Reference No.
Age, per 5-year increase

40%-70%

8-15
Prior fracture

50%-200%

9, 11,13,14, 16-18,23
BMD, per SD decrease

30%-85%

10, 19-22,24
BMI,per SD decrease

12%-31%

14, 15
Weight, below 75 kg 100% 9
Maternal history of fracture

68%-80%

9, 11
Corticosteroid use

42%-342%

25,26
(current or prior)
Rheumatoid arthritis

73%-100%

27, 28
Smoking, current

18%-85%

29
Alcohol, intake more than

33%-72%

30
2 units (about 2 drinks) per day
* Relative risk not adjusted for other risk factors. BMD = bone mineral density; SD = standard deviation.

The presence of multiple risk factors substantially increases the overall rate of fractures. For example, the incidence of fractures for patients with zero to two independent risk factors, in addition to a low BMD T-score, is 2.6 hip fractures per 1,000. The rate of hip fracture for those with low BMD and five or more additional risk factors is 27.3 per 1,000. WHO has identified the cumulative role of risk factors for fractures and has generated a model estimating the 10-year probability of an osteoporotic fracture based on these risk factors.

A number of therapeutic options are available for treating bone loss and, ultimately, for avoiding fractures, and several promising agents are in development. More recent evidence has advanced our scientific understanding of why these agents help improve bone mass and structural quality, thus preventing fractures, and this new information is influencing current treatment opinions. However, new therapeutic alternatives and philosophies should consider pharmacoeconomic data that incorporate risk reduction in terms of baseline risks to ensure that the products used are cost-effective. New approaches and economic considerations could change the way health care organizations shape their formularies and recommended treatment guidelines for postmenopausal osteoporosis (PMO).

Our objective was to conduct a thorough review of recent clinical trial and pharmacoeconomic literature related to osteoporo­sis pharmacotherapy. This article summarizes the literature regarding efficacy, safety, and economic data for current and future pharmaceutical treatments specifically related to PMO, which represents a significant portion of the total population with osteoporosis.