Associations Between Baseline Risk Factors and Vertebral Fracture Risk in the Multiple Outcomes of Raloxifene Evaluation (MORE) Study

Authors

  • Olof Johnell,

    1. Department of Orthopaedics, Malmö General Hospital, Malmö, Sweden
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  • John A Kanis MD, PhD,

    Corresponding author
    1. WHO Centre for Metabolic Bone Diseases, University of Sheffield, Sheffield, United Kingdom
    • WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield S10 2RX, UK
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  • Dennis M Black,

    1. Division of Clinical Epidemiology, University of California, San Francisco, California, USA
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    • Drs Pavo, Zhou, and Sarkar received corporate appointments and stock from Eli Lilly and Company. Dr Black serves as a speaker for and receives research contracts from Merck, Novartis, and NPS Pharmaceuticals. Dr Kanis served as a consultant for Eli Lilly and Company. All other authors have no conflict of interest.

  • Adam Balogh,

    1. Department of Obstetrics and Gynecology, Medical and Health Science Center, University of Debrecen, Debrecen, Hungary
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  • Gyula Poor,

    1. National Institute of Rheumatology and Physiotherapy, Budapest, Hungary
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  • Somnath Sarkar,

    1. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA
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    • Drs Pavo, Zhou, and Sarkar received corporate appointments and stock from Eli Lilly and Company. Dr Black serves as a speaker for and receives research contracts from Merck, Novartis, and NPS Pharmaceuticals. Dr Kanis served as a consultant for Eli Lilly and Company. All other authors have no conflict of interest.

  • Chunmei Zhou,

    1. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA
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    • Drs Pavo, Zhou, and Sarkar received corporate appointments and stock from Eli Lilly and Company. Dr Black serves as a speaker for and receives research contracts from Merck, Novartis, and NPS Pharmaceuticals. Dr Kanis served as a consultant for Eli Lilly and Company. All other authors have no conflict of interest.

  • Imre Pavo

    1. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA
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    • Drs Pavo, Zhou, and Sarkar received corporate appointments and stock from Eli Lilly and Company. Dr Black serves as a speaker for and receives research contracts from Merck, Novartis, and NPS Pharmaceuticals. Dr Kanis served as a consultant for Eli Lilly and Company. All other authors have no conflict of interest.


Abstract

Different risk factors may influence the effectiveness of osteoporosis therapies. The interaction of 30 baseline risk factors and the effectiveness of raloxifene in the MORE study were assessed. The efficacy of raloxifene in reducing vertebral fractures is largely independent of the presence of clinical risk factors for osteoporotic fractures.

Introduction: The aim of this analysis was to determine the effect of different risk factors on the effectiveness of raloxifene to reduce vertebral fractures in the Multiple Outcomes of Raloxifene Evaluation (MORE) study using logistic regression models.

Materials and Methods: The association was assessed using univariate analyses and a multivariate model between 30 potential risk factors at baseline and the risk of vertebral fractures after 3 years in the placebo group, as well as the interaction of risk factors with raloxifene therapy (at a dose of 60 or 120 mg/day).

Results and Conclusions: In the univariate analysis of the placebo group, after adjusting for baseline lumbar spine BMD (LS BMD), short stature (odds ratio [OR] = 1.18), age (OR = 1.38), years since menopause (OR = 1.38), impaired cognitive function, visuospatial capabilities (OR = 1.19), impaired musculoskeletal strength (OR = 1.23), low femoral neck BMD (OR = 1.21), and prior vertebral fracture (OR = 4.95) were significantly associated with the incidence of new vertebral fractures. In the univariate analysis, significant interactions were observed between raloxifene treatment and age (p = 0.04), serum triglycerides (p = 0.03), LS BMD (p = 0.08), and diabetes mellitus (p = 0.04). In the multivariate analysis, the effectiveness of raloxifene was independent of almost all risk factors, with the exception of baseline serum triglyceride level and LS BMD, suggesting an increased efficacy of raloxifene in patients with increased triglyceride levels (p = 0.006) and lower LS BMD values (p = 0.008) at baseline. These data suggest that the efficacy of raloxifene in reducing vertebral fractures is largely independent of the presence of clinical risk factors for osteoporotic fractures.

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