Current Osteoporosis Reports

, Volume 9, Issue 3, pp 160–166

Diagnostic Thresholds in Osteoporosis: How Are They Used in Clinical Trials?

Authors

    • James H. Quillen College of MedicineEast Tennessee State University
  • Dustin M. Price
    • James H. Quillen College of Medicine
  • Miriam M. Mottl
    • University of Rostock Medical School
Article

DOI: 10.1007/s11914-011-0063-2

Cite this article as:
Hamdy, R.C., Price, D.M. & Mottl, M.M. Curr Osteoporos Rep (2011) 9: 160. doi:10.1007/s11914-011-0063-2
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Abstract

Clinical trials are used to determine the efficacy and safety of a medication prior to approval for commercial use and to influence the prescribing habits of clinicians. The lack of uniformity in the diagnostic thresholds used in clinical trials on osteoporosis makes it difficult to compare the results of these trials. The use of placebo, different anatomical sites, T-score cutoff points, and risk factors precludes any meaningful comparison being made between the outcomes of clinical trials. Finally, the lack of uniform reporting format makes it difficult to retrieve important information to compare one medication to another. Because the diagnostic thresholds used affect the outcomes of these trials, health care providers need to be aware of these criteria to determine whether the results of a particular clinical trial can be applied to a particular patient.

Keywords

OsteoporosisRandomized clinical trialsDiagnostic thresholdsProblemsEvidence-basedHIPVERTFITBONEMOREPROOF

Clinical Trial Acronyms

BONE

Ibandronate Osteoporosis Vertebral Fracture Trial in North America and Europe

FIT

Fracture Intervention Trial

FREEDOM

Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months

HIP

Hip Intervention Program

HORIZON

Health Outcomes and Reduced Incidence with Zoledronic Therapy

MORE

Multiple Outcomes of Raloxifene Evaluation

NHANES

National Health and Nutrition Examination Survey

PROOF

Prevent Recurrence of Osteoporosis Fracture

VERT

Vertebral Efficacy with Risedronate Therapy

Copyright information

© Springer Science+Business Media, LLC (outside the USA) 2011