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

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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.

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Abbreviations

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

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Acknowledgments

The authors thank Jennifer Culp and Lindy Russell for their assistance in the creation of this manuscript.

Disclosure

Conflicts of interest: R.C. Hamdy: has received honoraria from Eli Lilly, Amgen, Warner-Chilcott, and Novartis; and has received travel/accommodations expenses covered or reimbursed from Eli Lilly, Amgen, Warner-Chilcott, and Novartis; D.M. Price: none; M.M. Mottl: none.

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Authors and Affiliations

  1. James H. Quillen College of Medicine, East Tennessee State University, P.O. Box 70429, Johnson City, TN, 37614, USA

    Ronald C. Hamdy

  2. James H. Quillen College of Medicine, 1113 High Street Unit 201, Johnson City, TN, 37604, USA

    Dustin M. Price

  3. University of Rostock Medical School, Rostock, Germany

    Miriam M. Mottl

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  1. Ronald C. Hamdy
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  2. Dustin M. Price
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  3. Miriam M. Mottl
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Correspondence to Ronald C. Hamdy.

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Hamdy, R.C., Price, D.M. & Mottl, M.M. Diagnostic Thresholds in Osteoporosis: How Are They Used in Clinical Trials?. Curr Osteoporos Rep 9, 160–166 (2011). https://doi.org/10.1007/s11914-011-0063-2

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