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Management of Postmenopausal Osteoporosis

Defining the Role of Raloxifene

  • Drugs In Disease Management
  • Published:
Disease Management & Health Outcomes

Abstract

Postmenopausal osteoporosis is a very common disease, and approximately half of all women aged >50 years will experience an osteoporotic fracture during the remainder of their lifetime. The predominant cause of postmenopausal osteoporosis is the decline in estrogen levels, which causes an increase in bone turnover, and results in a loss of bone mass throughout the entire skeleton. Fragility fractures, either vertebral or nonvertebral, have a considerable adverse effect on quality of life in women with osteoporosis and place a significant burden on society in terms of healthcare costs.

Management of postmenopausal osteoporosis includes alteration of modifiable risk factors (e.g. lifestyle and propensity to fall), ensuring adequate calcium and vitamin D intake, and pharmacological treatment to decrease fracture risk by slowing or preventing bone loss and preserving bone strength. Raloxifene (Evista®), a selective estrogen receptor modulator that partially mimics the effects of estrogen on bone and lipid metabolism and acts as an antiestrogen in the breast and endometrium, is indicated for the prevention and treatment of postmenopausal osteoporosis. Raloxifene increases bone mineral density at vertebral and nonvertebral sites, and decreases the risk of vertebral fracture to a similar extent to the bisphosphonates alendronate and risedronate. However, effects on nonvertebral fracture risk, including the risk of hip fracture, have not been observed.

Raloxifene appears to reduce breast cancer risk (in women at average risk) and cardiovascular risk (in women at increased risk) without stimulating the endometrium, and does not cause vaginal bleeding or breast pain. However, the drug causes hot flashes in some women, and increases the risk of venous thromboembolic events by about the same amount as hormone replacement therapy (HRT).

In economic models, raloxifene is cost effective compared with no treatment, HRT, calcitonin, or alendronate for the prevention or treatment of postmenopausal osteoporosis.

In conclusion, raloxifene is a valuable and cost-effective therapy for preventing the progression of osteoporosis and for reducing vertebral fracture risk in osteoporotic postmenopausal women. The tendency for raloxifene to cause hot flashes, and its apparent lack of effect on hip fracture risk, may preclude its use in women with vasomotor symptoms and in patients at high risk for hip fracture. Results from large ongoing trials are needed to confirm the effects of raloxifene on breast cancer and cardiovascular disease. However, the effects of raloxifene on breast cancer and cardiovascular risk without stimulating the endometrium make the drug an attractive therapy for the prevention and treatment of postmenopausal osteoporosis.

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  1. Use of tradenames is for product identification purposes only and does not imply endorsement.

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Authors and Affiliations

  1. Adis International Inc., 770 Township Line Road, Suite 300, Yardley, Pennsylvania, PA 19067, USA

    Keri Wellington & Greg L. Plosker

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  1. Keri Wellington
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Correspondence to Keri Wellington.

Additional information

Various sections of the manuscript reviewed by: C. Cradall, Iris Cantor-UCLA Women’s Health Center, UCLA School of Medicine, Los Angeles, California, USA; H.W. Deng, Osteoporosis Research Center, Creighton University, Omaha, Nebraska, USA; J-Y. Reginster, Department of Epidemiology and Public Health, University of Leìge, Leìge, Belgium; D.M. Reid, Department of Medicine and Therapeutics, University of Aberdeen, Aberdeen, United Kingdom; I.R. Reid, Department of Medicine, University of Auckland, Auckland, New Zealand; S.M. Setter, Elder Services/Visiting Nurses Association, Washington State University, Spokane, Washington, USA; P. Vestergaard, The Osteoporosis Clinic, Århus Amtssygehus, Århus, Denmark.

Data Selection

Sources: Medical literature published in any language since 1980 on raloxifene, identified using Medline, supplemented by AdisBase (a proprietary database of Adis International). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: Medline search terms were ‘postmenopausal osteoporosis’ and (‘guidelines’ or ‘decision-making’ or ‘health-policy’ or ‘managed-care-programs’ or ‘epidemiology’ or ‘outcome-assessment-health-care’ or ‘clinical-protocols’ or ‘guideline in pt’ or ‘polic* in ti’ or ‘expert panel’ or ‘utilization review’ or ‘algorithms’ or ‘disease management’ or ‘quality of life’), or ‘raloxifene’ and ‘postmenopausal osteoporosis’ and ‘review in pt’. AdisBase search terms were ‘postmenopausal-osteoporosis’ and (‘guideline’ or ‘guideline-utilisation’ or ‘practice-guideline’ or ‘disease-management-programmes’ or ‘treatment-algorithms’ or ‘reviews-on-treatment’ or ‘drug-evaluations’ or ‘epidemiology’ or ‘cost-of-illness’ or ‘pathogenesis’), or ‘raloxifene’ and ‘postmenopausal-osteoporosis’ and (‘review’ or ‘clinical-study’). Searches were last updated September 22, 2003.

Selection: Studies in postmenopausal women who received raloxifene. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic, pharmacokinetic, pharmacoeconomic and epidemiological data are also included.

Index terms: Raloxifene, osteoporosis, postmenopausal, disease management, review on treatment.

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Wellington, K., Plosker, G.L. Management of Postmenopausal Osteoporosis. Dis-Manage-Health-Outcomes 11, 673–692 (2003). https://doi.org/10.2165/00115677-200311100-00006

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