Reproducibility and diagnostic sensitivity of ultrasonometry of the phalanges to assess osteoporosis.

OBJECTIVE: The present study was designed to assess the reproducibility and the diagnostic sensitivity of the amplitude-dependent speed of sound (SoS) at the distal metaphysis of the proximal phalanges. METHOD: Fourteen presumably healthy volunteers were repeatedly measured every 6 weeks for approximately 6 months in order to assess the reproducibility of the SoS of the phalanges. We recruited 91 post-menopausal women, aged 55-75 years, who were divided in three groups according to their lumbar bone mineral density (BMD) and the existence of prevalent vertebral fractures. The objective was to evaluate the diagnostic sensitivity of SoS measurements. We used DBM Sonic 1200 equipment, and assessed the velocity at which US cross the phalanx in a lateral-medial direction. In post-menopausal women, BMD was measured by dual energy X-ray absorptiometry (DXA) at the level of the lumbar spine, the total zone of the non-dominant hip and the femoral neck zone of the non-dominant hip. RESULTS: The precision of the SoS measurements was 0.71+/-0.05% (mean+/-S.E.M) whereas the reproducibility was 0.95+/-0.06%. Subjects with low BMD or prevalent fractures had significantly lower values of SoS (P < 0.001) than the controls. ROC curve analysis applied to the study population confirmed that SoS was able to discriminate between the controls and osteoporotic subjects (area under the ROC curves were 0.82 (low bone mineral density) and 0.85 (prevalent fractures), respectively). Hip BMD was found to be the most significant variable when comparing the controls and the low density patients by stepwise discrimination and SoS significantly improved the discrimination between the groups when added to the hip BMD. The hip BMD was again the most discriminant variable when applying the same techniques to controls and patients with prevalent fractures, followed by SoS and lumbar BMD. A cut-off value of 1881 m/s is defined for SoS by logistic discrimination and likelihood ratio function. With this value, the sensitivity and the specificity for SoS used in the diagnosis of established osteoporosis were, 81.5% and 79.3%, respectively. Sensitivity and specificity were significantly improved when combining ultrasonometry and densitometry. CONCLUSION: Measurement of ultrasound velocity at the phalanges appears to be a precise and reproducible technique. SoS discriminates between normal post-menopausal women and patients with either low lumbar BMD or prevalent fractures to the same extent as BMD measurements.

[Comparison of changes in biochemical markers of bone turnover after 6 months of hormone replacement therapy with either transdermal 17 beta-estradiol or equine conjugated estrogen plus nomegestrol acetate]. / Comparaison de l'évolution des marqueurs biologiques du remodelage osseux après six mois de traitement hormonal substitutif par 17 beta-estradiol cutané ou estrogènes sulfoconjugués équins et acétate de nomégestrol.

OBJECTIVE: To compare changes in biochemical markers of bone turnover in postmenopausal women who received sequential discontinuous hormone replacement therapy (HRT) with either transdermal 17 beta-estradiol gel (group 1) or oral equine sulfoconjugated estrogen (group 2), plus nomegestrol acetate. PATIENTS AND METHOD: Prospective, open, randomized, controlled trial, conducted on 3 parallel groups of 106 postmenopausal women. All treated groups received estrogen therapy for 25 consecutive days every month. The estrogen used was either 1.5 mg/day of transdermal 17 beta-estradiol gel (group 1) [N = 42, average age (AA) = 51.6 years, average duration of menopause (ADM = 21.5 months)], or 0.625 mg/day of oral equine sulfoconjugated estrogen (group 2) [N = 39, AA = 51.3 years, ADM = 16.8 months]. In all cases nomegestrol acetate 5 mg/day was added for 12 consecutive days every month. The control group comprised 25 patients, [AA = 53.4 years, ADM = 33.7 months]. Two bone resorption markers: urinary cross-linked N-telopeptide and C-telopeptide of type I collagen (U-NTX/Cr, U-CTX/Cr), and a bone formation marker: serum bone specific alkaline phosphatase activity were measured before and 6 months after treatment start. RESULTS: Significant decreases from baseline values were observed for the 3 biochemical markers in both treated groups compared with control (P < 0.001). There were no significant differences in changes between the 2 treated groups for the 3 biochemical markers. The mean percentage change in the 3 biochemical markers was: from -9.3 to -45.5% in group 1, from -20.5 to -39% in group 2, and from -3.3 to 2% in control group. In group 1, the mean percentage decreases in U-CTX reached optimal threshold of bone turnover change (-45%) which is considered by the International Osteoporosis Foundation as clinically relevant because it predicts an increase in BMD greater than 3% when treatment is maintained over a long term. DISCUSSION AND CONCLUSION: Both treated groups induced a significant comparable decrease of bone turnover markers after 6 months of intervention, compared with control. The group treated with cyclic administration of transdermal 17 beta-estradiol (1.5 mg/day) and nomegestrol acetate (5 mg/day) showed a bone resorption markers decrease corresponding to the threshold of clinical relevance described in the international literature and predictive of positive BMD response in long term.