Advertisement

Instrument Measurements in Osteoporosis Clinical Trials: Evaluating the Endpoints

  • Colin G. Miller

Abstract

Medical instruments can be used in one of four primary ways: for screening, diagnosis and or prognosis, monitoring the natural history of the disease or therapeutic intervention. Good quantitative endpoints in clinical trials are usually obtained from instruments measuring a physiological parameter that is relevant to the anticipated effect of the molecular entity under investigation, and nowhere is this more apparent than in the field of osteoporosis. The surrogate endpoint of choice, BMD, is in fact a recognized diagnostic endpoint in its own right, with the World Health Organization (WHO) criterion defining an individual with a BMD that is more than 2.5 SD below peak bone mass as osteoporotic. However, in the arena of clinical trials it is not quite as simple as this (see section on endpoints in Chapter 2).

Keywords

Vertebral Fracture Vertebral Deformity Vertebral Fracture Assessment Fracture Intervention Trial Spine Deformity Index 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Conroy RM, O’Brien E, O’Malley K, Atkins N. Measurement error in the Hawksley Random Zero Sphygmomanometer; what damage has been done and what can we learn? BMJ 1993; 306: 1319–22.PubMedCrossRefGoogle Scholar
  2. 2.
    Notes for Guidance on Postmenopausal Osteoporosis in Women. CPMP, 2001 (http://www.emea.eu.int/pdfs/human/ewp/055295en.pdf).
  3. 3.
    Bauer DC, Gluer CC, Cauley JA et al. Broadband ultrasound attenuation predicts fractures strongly and independently of densitometry in older women. A prospective study. Study of Osteoporotic Fractures Research Group. Arch Intern Med 1997; 157: 629–34.PubMedCrossRefGoogle Scholar
  4. 4.
    Hans D, Dargent-Molina P, Schott AM et al. Ultrasonographic heel measurements to predict hip fracture in elderly women: the EPIDOS prospective study. Lancet 1996; 348: 511–14.PubMedCrossRefGoogle Scholar
  5. 5.
    Pluijm SMF, Graafmans WC, Bouter LM, Lips P. Ultrasound measurements for the prediction of osteoporotic fractures in elderly people. Osteoporos Int 1999; 9: 550–6.PubMedCrossRefGoogle Scholar
  6. 6.
    McCloskey EV, Spector TD, Eyres KS et al. The assessment of vertebral deformity: A method for use in population studies and clinical trials. Osteoporos Int 1993; 3: 138–47.PubMedCrossRefGoogle Scholar
  7. 7.
    Minne HW, Leidig G, Wuster C et al. A newly developed spine deformity index (SDI) to quantitate vertebral crush fractures in patients with osteoporosis. Bone Miner 1988; 3: 335–49.PubMedGoogle Scholar
  8. 8.
    Cawte SA. Morphometric X-ray absorptiometry using the Hologic QDR 2000. MPhil Thesis, University of Nottingham, 1999.Google Scholar
  9. 9.
    Black DM, Cummings SR, Karpf DB et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 1996; 348: 1535–41.PubMedCrossRefGoogle Scholar
  10. 10.
    National Osteoporosis Foundation Working Group on Vertebral Fractures. Report Assessing Vertebral Fractures. J Bone Miner Res 1995; 10: 518–22.Google Scholar
  11. 11.
    Genant HK, Jergas M, van Kuijk C. Vertebral Fractures in Osteoporosis. San Fransisco: Radiology Research Education Foundation, 1995.Google Scholar
  12. 12.
    Genant HK, Wu CY, van Kuijk C, Nevitt MC. Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res 1993; 8: 1137–48.PubMedCrossRefGoogle Scholar
  13. 13.
    Jergas M, Genant HK, Nevitt MC. Standardized visual assessment of osteoporotic vertebral deformities. In: Genant HK, Jergas M, van Kuijk C. Vertebral Fractures in Osteoporosis. San Francisco: Radiology Research Education Foundation, pp 149–61, 1995.Google Scholar
  14. 14.
    Miller CG, Herd RJM, Ramalingham I et al. Ultrasonic velocity measurements through the calcaneus; which velocity should be measured? Osteoporos Int 1993; 3: 31–5.PubMedCrossRefGoogle Scholar
  15. 15.
    Morris M, Peretz A, Tjeka R et al. Quantitative ultrasound bone measurements: Normal values and comparison with bone mineral density by dual X-ray absorptiometry. Calcif Tissue Int 1995; 57: 6–10.CrossRefGoogle Scholar
  16. 16.
    Langton CM. ZSD: A universal parameter for ultrasound precision. Physiol Meas 1997; 18: 67–72.PubMedCrossRefGoogle Scholar
  17. 17.
    Liu G, Peacock M, Eilam O, Dorulla G, Braunstein E, Johnston CC. Effect of osteoarthritis in the lumbar spine and hip on bone mineral density and diagnosis of osteoporosis in elderly men and women. Osteoporos Int 1997; 7: 564–9.PubMedCrossRefGoogle Scholar
  18. 18.
    Cummings SR, Black DM, Thompson DE et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA 1998; 280: 2077–82.PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag London 2002

Authors and Affiliations

  • Colin G. Miller

There are no affiliations available

Personalised recommendations