Synarc Inc., Lübecker Strasse 128, Hamburg, Germany.
Osteoporos Int. 2012 Aug;23(8):2151-8. doi: 10.1007/s00198-011-1829-1. Epub 2011 Dec 6.
In vivo hr-pQCT precision was determined in 42 postmenopausal women using double baseline measurements from a multicenter trial of odanacatib. Errors, e.g., at the radius below 1.3% for BMD and below 6.3% for trabecular structure, were comparable to single-center results. Motion artifacts remain a challenge, particularly at the forearm.
The short-term in vivo precision of BMD, trabecular bone structure, cortical thickness and porosity of the forearm and tibia was measured by hr-pQCT. Also the effect of image quality on precision was evaluated.
In 42 postmenopausal women (age 64.4 ± 6.8 years) out of 214 subjects enrolled in a multi center advanced imaging phase III study of odanacatib (DXA spine or hip T-scores between -1.5 and -3.5), double baseline hr-pQCT (XtremeCT) measurements with repositioning were performed. The standard ultradistal location and a second, more proximally located VOI were measured at the radius and tibia to better assess cortical thickness and porosity. Image analysis and quality grading (grades: perfect, slight artifacts, pronounced artifacts, unacceptable) were performed centrally.
At the radius RMS%CV values varied from 0.7% to 1.3% for BMD and BV/TV and from 5.6% to 6.3% for Tb.Sp, Tb.Th, Tb.N, and cortical porosity. Numerically at the tibia, precision errors were approx. 0.5% lower for BMD and 1% to 2% lower for structural parameters although most differences were insignificant. In the radius but not in the tibia, precision errors for cortical thickness were smaller at the distal compared to the ultradistal location (1% versus 2%).
BMD precision errors were lower than those for trabecular architecture and cortical porosity. Motion artifacts remain a challenge, particularly at the forearm. Quality grading remains subjective, and more objective evaluation methods are needed. Precision in the context of a multicenter clinical trial, with centralized training and scan analysis, was comparable to single-center results previously reported.
在一项多中心奥达那曲特研究中,对 42 名绝经后妇女进行了双基线测量,以确定体内高分辨率 pQCT 的精确性。在桡骨,BMD 的误差为低于 1.3%,而小梁结构的误差为低于 6.3%,与单中心的结果相当。运动伪影仍然是一个挑战,尤其是在前臂。
通过高分辨率 pQCT 测量了前臂和胫骨的 BMD、小梁骨结构、皮质厚度和孔隙率的短期体内精密度。还评估了图像质量对精密度的影响。
在 214 名入组奥达那曲特多中心高级成像 III 期研究的绝经后妇女(年龄 64.4±6.8 岁)中,对 42 名妇女进行了双基线高分辨率 pQCT(XtremeCT)测量和重新定位。在桡骨和胫骨处测量标准的远端位置和第二个更靠近近端的 VOI,以更好地评估皮质厚度和孔隙率。中央进行图像分析和质量分级(分级:完美、轻微伪影、明显伪影、不可接受)。
在桡骨处,RMS%CV 值在 BMD 和 BV/TV 中为 0.7%至 1.3%,在 Tb.Sp、Tb.Th、Tb.N 和皮质孔隙率中为 5.6%至 6.3%。在胫骨处,数值上 BMD 的精密度误差约低 0.5%,结构参数低 1%至 2%,尽管大多数差异无统计学意义。在桡骨中,但不在胫骨中,皮质厚度的精密度误差在远端比在超远端位置小(1%比 2%)。
BMD 的精密度误差低于小梁结构和皮质孔隙率。运动伪影仍然是一个挑战,尤其是在前臂。质量分级仍然是主观的,需要更客观的评估方法。在多中心临床试验的背景下,经过集中培训和扫描分析,其精确性与以前报道的单中心结果相当。