PMID: 11344056May 10, 2001Paper

How many patients are needed? Variation and design considerations in bone histomorphometry

Bone
E HaugeM Frydenberg

Abstract

In osteoporosis research, bone histomorphometry plays an important role in documenting the biological effects and possible side-effects of new drug treatments. To ensure that the study is properly scaled, it is important to be concerned with the risk of type II error; that is, the risk of failing to detect a real difference. We therefore calculated the necessary sample size in bone histomorphometric studies according to a specified difference of 15% between two groups. The calculations were based on variance components estimated from three different studies: women with a distal fracture of the forearm (n = 22); patients with pituitary insufficiency (n = 21); and patients with primary hyperparathyroidism (n = 21). Using a significance level of 0.05 and a risk of type II error of 0.20, the statistical power of two different designs was compared: a single biopsy design comparing the responses in two groups after the treatment; and a paired biopsy design in which individual differences (posttreatment minus baseline) were calculated before the comparison of the two groups. We found that the mineral apposition rate, wall thickness, and erosion depth are statistically powerful indices that, in the single biopsy design, require no more...Continue Reading

References

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Citations

Mar 25, 2009·Calcified Tissue International·Ylva PernowMaria Sääf
May 19, 2005·Current Medical Research and Opinion·Paul D MillerRichard D Wasnich
Apr 2, 2005·Current Medical Research and Opinion·R ReckerD Kimmel
Apr 25, 2007·Biomarkers : Biochemical Indicators of Exposure, Response, and Susceptibility to Chemicals·M G SørensenM A Karsdal
Sep 26, 2007·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Robert R ReckerErik F Eriksen
Oct 27, 2011·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Craig R SlyfieldChristopher J Hernandez
Feb 24, 2006·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Robert LindsayDavid W Dempster
Oct 10, 2007·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Monique E ArlotPierre J Meunier
Jan 13, 2021·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·David W DempsterBruce H Mitlak

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