Compliance with drug therapies for the treatment and prevention of osteoporosis
Section snippets
Background
Osteoporosis is a disease characterized by low bone mass density and micro-architectural deterioration of bone that increases the risk of bone fracture resulting in pain and deformity. Osteoporosis is considered a significant public health concern that will be magnified in the future as the population ages in the developed world. The National Osteoporosis Foundation (NOF) [1] estimates that low bone density affects about 44 million men and women in the US based on 2000 census data. This
Objectives
This study is designed to investigate patient compliance with drug therapies use to prevent and treat osteoporosis in real-world treatment settings, and to estimate the cost-consequences associated with non-compliance. Particular attention will be paid to comparing the patient outcomes achieved using estrogen-only, estrogen plus progestin, raloxifene or bisphosphonate. This study is particularly important on three fronts. First, the cost-effectiveness of alternative drug therapies to treat
Data
Data for this analysis were derived from the historical paid claims files for a large health insurance company located in California. Paid claims from the period January 1, 1998 to August 30, 2001 were available for inclusion in the analysis. These data included claims for prescription drugs, hospitalizations, physicians’ services, home health care, laboratory tests, emergency room visits, physical therapy and durable medical equipment. Patients were covered under a variety of insurance plans
Baseline characteristics
Table 2 presents data for the baseline demographic characteristics of patients by initial drug therapy. As expected, there are statistically significant and important differences across the four treatment groups under study. Based on this dataset, HRT is the dominant therapy among osteoporosis patients (91.0%). Only 6.4% of the patients used bisphosphonate; and 2.6% used raloxifene. Patients initiating hormone replacement therapy are younger than patients bisphosphonate or raloxifene and more
Discussion
Retrospective database analyses using paid claims data present an array of advantages and limitations relative to randomized clinical trials. First, clinicians require better data on how well alternative treatment options perform in unrestricted, real-world clinical settings. Compliance data from well controlled clinical trials does not correspond well to real-world practice as clinical trials are typically designed to minimize subject drop-out. It is also difficult to adequately measure health
Limitaitons
While great care has been taken to adjust estimated results for the baseline clinical characteristics of the patient population, other unobserved factors may exist that are correlated with the patient outcome measures studied here. Of particular concern is the lack of data for height, weight and bone density that are likely to be correlated with both patient outcomes and the selection of an initial therapy. Moreover, this analysis considers only the initial osteoporosis drug therapy used by the
Conclusions
Taken as a whole, patients who achieve 1 year of uninterrupted drug therapy for osteoporosis achieve better patient outcomes than patients who terminate or interrupt therapy during the first year. Unfortunately, less than 25% of patients achieve in excess of 1 year without breaking therapy and approximately 30% of patients switch therapies. This is a mixed blessing. The Women’s Health Initiative study [21] found that the long-term use of estrogen and progestin combination therapy (average 5.2
References (25)
The burden of osteoporosis: cost
Am J Med.
(1995)Compliance to hormone replacement therapy in menopausal women controlled in a third level academic center
Maturitas
(1994)- et al.
Drug related negative side-effects is a common reason for poor compliance with hormone replacement therapy
Maturitas
(1999) - America’s Bone Health: The State of Osteoporosis and Low Bone Mass. NOF: National Osteoporosis Foundation. 2002 Report....
- et al.
How many women have osteoporosis?
J Bone Miner. Res.
(1992) - et al.
Isolating the cost of osteoporosis-related fractures for postmenoposal women
Gerontology
(2001) - et al.
Medical expenditures for the treatment of osteoporotic fractures in the United States in 1995: Report from the National Osteoporosis Foundation
J Bone Miner. Res.
(1997) The crippling consequence of fractures and their impact on quality of life
Am J Med.
(1997)- Seeman E. Osteoporosis: trials and tribulations. Am J Med 1997;103(2A) Supplement...
The economic and human costs of osteoporotic fracture
Am J Med.
(1995)
The socioeconomic burden of fractures: today and in the 21st century
Am J Med
The economic cost of hip fractures in community-dwelling older adults: a prospective study
J Am Geriatr Soc
Cited by (333)
ROCK-II inhibition suppresses impaired mechanobiological responses in early estrogen deficient osteoblasts
2020, Experimental Cell Research