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H K Genant

Publications and source records attributed to H K Genant.

At least 163 records · Page 9Linked to original sources
PubMed1998

Good clinical practice and audits for dual X-ray absorptiometry and X-ray imaging laboratories and quality assurance centers involved in clinical drug trials, private practice, and research.

Good Clinical Practice (GCP) guidelines, with an emphasis on quality and validation of processes and data, must be applied to the use of imaging in clinical drug development. All participants, including the sponsor, principal investigator, site staff, quality assurance centers, and contract research organizations, must be cognizant of the need for application of these principles to their activities related to the imaging programs. This article discusses the various aspects of GCP as they need to be applied to the use of dual X-ray absorptiometry (DXA) for bone densitometry and X-rays for vertebral fracture assessment in clinical trials for osteoporosis, as well as research and private practice settings. The theory of proper audit conduct to verify clinical trial data is presented.

Journal Article↗
PubMed1998

Tear of the posterior shoulder stabilizers after posterior dislocation: MR imaging and MR arthrographic findings with arthroscopic correlation.

OBJECTIVE: The purpose of this article is to describe the findings on MR imaging and MR arthrography in posterior capsular tear and teres minor muscle injury after posterior dislocation. We also correlate MR imaging with the arthroscopic findings and present treatment options for these patients. CONCLUSION: MR imaging is helpful in diagnosing abnormalities caused by posterior dislocation injuries and in directing therapy. Teres minor muscle and capsular injuries may occur without the typical reverse Bankart lesion. Isolated teres minor muscle tears seen on MR imaging after posterior dislocation injury may cause pain. However, no consensus exists as to whether the lesions seen on MR images in these patients should be treated surgically or conservatively.

Adolescent↗
PubMed1997

Comparative calibration without a gold standard.

Comparative calibration is the broad statistical methodology used to assess the calibration of a set of p instruments, each designed to measure the same characteristic, on a common group of individuals. Different from the usual calibration problem, the true underlying quantity measured is unobservable. Many authors have shown that this problem, in general, does not have a unique solution. Most commonly used assumptions to obtain a unique solution are (i) one instrument is the gold standard (that is, unbiased) and (ii) the measurement errors of the p instruments are independent. Such constraints, however, may not be valid for many clinical applications, for example, the universal standardization project for dual X-ray absorptiometry (DXA) scanners. In this paper, we propose a new approach to resolve the comparative calibration problem when a gold standard is unavailable. Instead of the usual assumptions, we use external information in addition to data from the p instruments, to solve the problem. We address statistical estimation, hypothesis testing and missing data problems. We apply the new method specifically to the universal standardization project data where a group of individuals have been measured for bone mineral density (BMD) by three DXA scanners. We compare the results of the new method to currently used methods and show that they have better statistical properties.

Absorptiometry, Photon↗
PubMed1997

Broadband ultrasound attenuation predicts fractures strongly and independently of densitometry in older women. A prospective study. Study of Osteoporotic Fractures Research Group.

BACKGROUND: Quantitative ultrasound of bone is a new radiation-free technique that measures bone mass and may assess bone quality. Retrospective studies have suggested that low-bone ultrasound of the calcaneus is associated with an increased risk for hip and other fractures in older women. OBJECTIVES: To establish the utility of calcaneal quantitative ultrasound of bone for the prediction of fractures and to compare quantitative ultrasound of bone with bone mineral densitometry by performing a prospective cohort study within the Study of Osteoporotic Fractures. SUBJECTS AND METHODS: We studied 6189 postmenopausal women older than 65 years of 4 US clinical centers. Broadband ultrasound attenuation (BUA), a measurement of the differential attenuation of sound waves transmitted through the calcaneus, and bone mineral density of the calcaneus and hip were measured. Subsequent hip and other nonspine fractures were documented during a mean follow-up of 2.0 years. RESULTS: In age- and clinic-adjusted analyses, each SD reduction in calcaneal BUA was associated with a doubling of the risk for hip fractures (relative risk [RR], 2.0; 95% confidence interval [CI], 1.5-2.7); a similar relationship was observed with bone mineral density of the calcaneus (RR, 2.2; 95% CI, 1.9-3.0) and femoral neck (RR, 2.6; 95% CI, 1.9-3.8). After adjustment for bone mineral density of the femoral neck, BUA was still associated with an increased risk for hip fracture (RR, 1.5; 95% CI, 1.0-2.1). Intertrochanteric fractures in particular were strongly associated with a low BUA measurement (RR, 3.3; 95% CI, 2.0-5.5). CONCLUSIONS: Broadband ultrasound attenuation predicts the occurrence of fractures in older women and is a useful diagnostic test for osteoporosis. The strength of the association between BUA and fracture is similar to that observed with bone mineral density.

Aged↗
PubMed1997

High resolution magnetic resonance imaging of the calcaneus: age-related changes in trabecular structure and comparison with dual X-ray absorptiometry measurements.

A high-resolution magnetic resonance imaging (MRI) protocol, together with specialized image processing techniques, was applied to the quantitative measurement of age-related changes in calcaneal trabecular structure. The reproducibility of the technique was assessed and the annual rates of change for several trabecular structure parameters were measured. The MR-derived trabecular parameters were compared with calcaneal bone mineral density (BMD), measured by dual X-ray absorptiometry (DXA) in the same subjects. Sagittal MR images were acquired at 1.5 T in 23 healthy women (mean age: 49.3 +/- 16.6 [SD]), using a three-dimensional gradient echo sequence. Image analysis procedures included internal gray-scale calibration, bone and marrow segmentation, and run-length methods. Three trabecular structure parameters, apparent bone volume (ABV/TV), intercept thickness (I.Th), and intercept separation (I.Sp) were calculated from the MR images. The short- and long-term precision errors (mean %CV) of these measured parameters were in the ranges 1-2% and 3-6%, respectively. Linear regression of the trabecular structure parameters vs. age showed significant correlation: ABV/TV (r2 = 33.7%, P < 0.0037), I.Th (r2 = 26.6%, P < 0.0118), I.Sp (r2 = 28.9%, P < 0.0081). These trends with age were also expressed as annual rates of change: ABV/TV (-0.52%/year), I.Th (-0.33%/year), and I.Sp (0.59%/year). Linear regression analysis also showed significant correlation between the MR-derived trabecular structure parameters and calcaneal BMD values. Although a larger group of subjects is needed to better define the age-related changes in trabecular structure parameters and their relation to BMD, these preliminary results demonstrate that high-resolution MRI may potentially be useful for the quantitative assessment of trabecular structure.

Absorptiometry, Photon↗
PubMed1997

Quantitative assessment of experimental fracture repair by peripheral computed tomography.

An experimental fracture model was used to assess bone mineral density at the fracture site by peripheral computed tomography and to compare the model with biomechanical, histological, and radiographic methods for the quantification of the fracture repair process. Transverse osteotomies in the mid-diaphysis of 28 tibia of sheep were externally fixed and mineral densities, cross-sectional areas, flexural rigidities, tissue composition, and projected callus area were calculated after 9 weeks of healing time. BMD measured by pQCT was strongly correlated with histologically determined percentages of mineralized tissue in the osteotomy gap (R = 0.71) and in the periosteal callus (R2 = 0.62). The percentage of mineralized tissue in the osteotomy gap was the best predictor of the flexural rigidity of the tibiae (R2 = 0.74). Because of high correlations with the histological findings, the volumetric BMD at the level of the osteotomy gap was also strongly correlated with the biomechanical findings (R2 = 0.70). Neither the cross-sectional area in pQCT nor the projected callus area in plane film radiography were positively correlated to the flexural rigidity of the tibiae. Quantitative computed tomography proved to be a successful estimator for the prediction of the mechanical stability of healing bones. The noninvasive procedure is a reliable tool for the quantification of the fracture repair process in experimental studies and may be useful for treatment decisions in particular clinical situations.

Animals↗
PubMed1997

Spinal trabecular bone loss and fracture in American and Japanese women.

This study examined trabecular bone mineral density (BMD) in Japanese women with and without spinal fracture, and compared the results to American women with and without fracture. The quantitative computed tomography (QCT) systems used at the University of California, San Francisco (UCSF) and at Nagasaki University were cross-calibrated. Normative BMD was assessed with the K2HPO4 liquid phantom in 538 Americans aged 20-85 years, and with the B-MAS200 phantom in 577 Japanese aged 20-83 years. These BMD were adjusted for use with the Image Analysis solid phantom using the result of cross-calibration. The trabecular BMD in 111 postmenopausal American women (55 with fracture), and in 185 postmenopausal Japanese women (67 with fracture) were compared for investigation of the difference in BMD values relative to fracture status. The absolute BMD values in Japanese were lower than those in Americans, and the differences were greater with advancing age. The magnitude of the BMD difference was 8.6, 20.5, 38.1 mg/cm3 in women aged 20-24 years, 40-44 years, 60-64 years, respectively. In premenopausal women, BMD began to decrease at the age of 20 in Japanese, whereas the peak bone mass was maintained until the age of 35 in the American women. In immediate postmenopausal women, BMD significantly decreased in both populations. In later postmenopausal women, BMD significantly decreased with age in the Japanese women but decreased less rapidly in the American women. The aging decrease of BMD was 1.4% and 2.2% per year in the later postmenopausal American and Japanese women, respectively. The fracture threshold is considered to be lower in Japanese women. However, the BMD difference between American and Japanese women with fracture was similar to that without fracture. The Z-scores of fracture subjects versus controls were 2.9 in American and 1.8 in Japanese women. In conclusion, Japanese women were found to have a lower BMD and lower fracture threshold than American women. The significant decrease of spinal trabecular BMD in late postmenopause is potentially responsible for the higher prevalence of spinal fracture in Japanese women.

Adult↗
PubMed1997

Spinal and femoral DXA for the assessment of spinal osteoporosis.

The objective was to determine the diagnostic sensitivity of spinal and femoral dual x-ray absorptiometry (DXA) and to study whether a combination of both sites may enhance discriminatory capability in regard to the presence of vertebral fractures. Spinal and femoral DXA were obtained in 324 postmenopausal women, of whom 90 had at least one vertebral fracture. Age-adjusted logistic regression analyses, ROC analyses, and sensitivity-specificity statistics were used to assess the discriminatory ability of spinal and femoral bone density (BMD) alone and in combination. The age-adjusted odds ratios per standard deviation decrease in BMD (OR) for spinal and femoral measurements were comparable (Ward's triangle: OR = 1.62; femoral neck: OR = 1.51; total hip: OR = 1.47; spine: OR = 1.34). Combining spinal and femoral bone density measurements did not improve diagnostic sensitivity of DXA considerably as compared to using BMD of a single site and adjusting the "fracture threshold." The conclusion drawn is that spinal and femoral BMD measurements using DXA have a comparable diagnostic sensitivity for vertebral fracture discrimination. Different individuals at risk for osteoporosis may be identified using both methods. The clinical usefulness of a combination of two bone density measurements needs further study in a prospective setting.

Absorptiometry, Photon↗
PubMed1997

Body size and hip fracture risk in older women: a prospective study. Study of Osteoporotic Fractures Research Group.

PURPOSE: To determine the relationship between measures of body size and the risk of hip fracture in elderly women. PARTICIPANTS AND METHODS: The association between measures of body size and hip fracture risk was assessed in 8,011 ambulatory, nonblack women 65 years of age or older enrolled in the Study of Osteoporotic Fractures with measurements of total body weight, percent weight change since age 25, hip girth, lean mass, fat mass, percent body fat, body mass index, modified body mass index, and femoral neck bone mineral density (BMD) at the second examination. These 8,011 women were followed prospectively for incident hip fractures occurring after the second examination, which were confirmed by review of x-ray films. RESULTS: During an average of 5.2 years after the second examination, 236 (2.9%) women experienced hip fractures. Similar associations were observed between hip fracture risk and all measures of body size including total body weight, percent weight change since age 25, hip girth, lean mass, fat mass, percent body fat, body mass index, and modified body mass index. Women with smaller body size had a higher risk of subsequent hip fracture compared with those with larger body size, while women with average and larger body sizes shared similarly lower risks of subsequent hip fracture. For example, the incidence rate of hip fracture was 9.35 per 1000 woman-years in women in the lowest quartile of total weight compared with 4.63 per 1000 woman-years in women in the highest quartile of total weight (age-adjusted relative risk 1.93, 95% confidence interval (CI) 1.34 to 2.80), while rates of hip fracture among women in the second and third quartiles of total weight (5.22 and 4.32 per 1000 woman-years, respectively) were not significantly different from the rate among women in the highest quartile (P > 0.64). The increased risk of hip fracture among women of smaller body size remained after further adjustment for additional potential confounding factors including height at age 25, smoking status, physical activity, health status, estrogen use, and diuretic use. After further adjustment for femoral neck BMD, women with smaller body size were no longer at significantly increased risk of hip fracture compared with those with larger body size. For example, after adjustment for height at age 25, smoking status, physical activity, health status, estrogen use, and diuretic use, thin women had a 2.5-fold increase in the risk of hip fracture (multivariate relative risk 2.51, 95% CI 1.69 to 3.73) compared with the referent group composed of the heaviest women. After further adjustment for femoral neck BMD, the multivariate relative risk of hip fracture among thin women compared to heaviest women was 0.98 (95% CI, 0.64 to 1.50). CONCLUSION: Older women with smaller body size are at increased risk of hip fracture. This effect is because of lower hip BMD in women with smaller body size. Assessment of body size for prediction of hip fracture risk can be accomplished by measuring total body weight.

Aged↗
PubMed1997

Increments in bone mineral density of the lumbar spine and hip and suppression of bone turnover are maintained after discontinuation of alendronate in postmenopausal women.

PURPOSE: Previously we have reported a significant increase in bone mineral density (BMD) of the spine and the hip and reductions in biochemical indices of bone turnover in postmenopausal women with osteoporosis treated with alendronate at various doses over 1 to 2 years. We have followed BMD and biochemical parameters in these patients for 1 or 2 years after discontinuation of alendronate to determine resolution of alendronate effects. PATIENTS AND METHODS: Participants received daily oral doses of placebo, 5 or 10 mg of alendronate for 2 years, or 20 or 40 mg of alendronate for 1 year followed by 1 year of placebo. No treatment was given in the third year of study. RESULTS: Lumbar spine BMD changes in the 5- and 10-mg groups (-1.4 and -0.4%) were similar to those in the placebo group (-1.2%) 1 year after discontinuation of drug and lumbar spine BMD changes in the 20- and 40-mg groups (-1.2% and 0.8%) were similar to those in the placebo group (-0.9%) 2 years after discontinuation of drug. BMD of the total hip followed the same pattern of resolution. The difference in BMD between alendronate and placebo groups at the end of alendronate treatment was maintained up to 2 years. Residual reductions in the bone resorption markers urinary deoxypyridinoline (D-Pyr) and collagen type 1 cross-linked N telopeptides and the bone formation markers serum bone-specific alkaline phosphatase and osteocalcin remained for 1 year after discontinuation of 5 and 10 mg of alendronate and for 2 years after discontinuation of 20 and 40 mg of alendronate, other than return of D-Pyr to baseline 1 year after cessation of treatment with the 5- and 10-mg doses. CONCLUSIONS: A residual decrease in bone turnover may be found up to 2 years after discontinuation of alendronate. Accelerated bone loss is not observed when treatment is discontinued. However, continuous therapy with alendronate is required to achieve a continuous gain in BMD.

Adult↗
PubMed1997

Cyclical etidronate in the treatment of postmenopausal osteoporosis: efficacy and safety after seven years of treatment.

PURPOSE: To determine the efficacy and safety of cyclical etidronate for up to 7 years in the treatment of postmenopausal osteoporosis and to examine the effects of discontinuing treatment after 2 or 5 years of therapy. PATIENTS AND METHODS: Patients were randomized at entry into the original study in 1986 to blinded treatment for 2 years with either a calcium (placebo) or an intermittent cyclical etidronate regimen, which most patients continued for a third year. Following this phase of the study, patients were enrolled into an open-label, follow-up study (years 4 and 5), during which all patients received cyclical etidronate treatment. In the present double-blind study (years 6 and 7), patients were rerandomized to receive intermittent cyclical therapy with either etidronate or placebo; all patients received calcium. The treatment regimen consisted of 400 mg/day etidronate or placebo for 14 days, followed by 76 days of elemental calcium (500 mg/day); this cycle was repeated approximately 4 times in each year. Of the 193 patients who continued in years 6 and 7 of the study, 93 were randomized to receive cyclical etidronate and 100 were randomized to receive calcium only. For purposes of efficacy analyses, patients were categorized by their total years of cumulative etidronate treatment (7, 5, 4, or 2 years). There were 51, 46, 42, and 54 patients in the 7-, 5-, 4-, and 2-year groups, respectively. Annual assessments included lumbar spine bone mineral density (BMD), as measured by densitometry, and vertebral radiographs. RESULTS: The groups receiving cyclical etidronate during this 2-year study period (7- and 4-year groups) had statistically significant mean percent increases in spinal BMD of 1.8% and 2.2%, respectively (P < 0.05) at the week 104 observation time. The 5- and 2-year groups, which did not receive etidronate during this period, had mean values of 1.4% and 0.2%, respectively (not significant) at week 104. In the 7-, 5-, 4-, and 2-year groups, the increases in spinal BMD at the end of 7 years were 7.6%, 8.6%, 8.1%, and 3.9%, respectively; these values were statistically significant for all groups compared with original baseline (year 0) (P < 0.05). BMD of the femur and wrist was maintained throughout the 7-year period. The incidence and rate of vertebral fractures were lowest in patients with the longest exposure to etidronate. Etidronate was well tolerated during the study, with low incidences of gastrointestinal side effects and nonvertebral fractures. CONCLUSIONS: Long-term cyclical etidronate is a safe, effective, and well-tolerated treatment for postmenopausal osteoporosis. Bone mass is maintained for at least 2 years after treatment with etidronate is stopped; however, further gains in spinal bone mass are seen in patients who continue therapy.

Aged↗
PubMed1997

Indirect MR arthrography: techniques and applications.

Indirect MR arthrography is a simple noninvasive alternative to direct MR arthrography and can potentially alter the diagnostic work-up of several diseases. Based on current knowledge, these diseases include rotator cuff tears. glenoid labrum tears, recurrent tears of the menisci and classification of osteochondritis dissecans. The technique is recommended for inclusion in the MRI diagnostic array, and may obviate the need for invasive direct MR arthrography. The technique and applications of indirect MR arthrography are summarized in this article, based on our own experiences and that described in the current literature.

Adipose Tissue↗
PubMed1997

How can we measure bone quality?

Osteoporosis is a systematic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue. This leads to diminished biomechanical competence of the skeleton and is associated with low-trauma or atraumatic fractures. In the past decade, considerable progress has been made in the development of methods for assessing the skeleton non-invasively, so that osteoporosis can be better managed. While dual X-ray absorptiometry (DXA) is still the preferred methodology, several limitations will be addressed. Another densitometric technique which is widely accepted for diagnosis of spinal osteoporosis is single energy QCT. Measurements of vertebral trabecular bone mineral density (BMD) demonstrate larger percentage decrements between vertebrally-fractured subjects and normal controls, and confer higher relative risks for vertebral fracture than either anteroposterior or lateral DXA measurements. As an emerging alternative to photon absorptiometry techniques, there is a growing interest in the use of quantitative ultrasound (QUS) measurements for the non-invasive assessment of osteoporotic fracture risk in the management of osteoporosis. The attractiveness of QUS lies in the fact that indirect and in vitro experience has suggested that ultrasound may give information not only about BMD but also about architecture and elasticity. Whether or not combining QUS and DXA improve fracture prediction is still unclear and needs further analysis. Due to the growing evidence supporting the use of QUS in osteoporosis and the large number of QUS devices already on the market, a general clinical consensus on the application of QUS is urgently needed. Other techniques that are less widely used for the management of osteoporosis. For example, peripheral quantitative computed tomography, quantitative magnetic resonance (QMR) and magnetic resonance microscopy are promising tools for the evaluation of the skeleton. For example, the ability of QMR and high resolution magnetic resonance imaging has been explored and shows promise as a technique for assessing trabecular bone structure in osteoporosis.

Absorptiometry, Photon↗
PubMed1997

Texture analysis of direct magnification radiographs of vertebral specimens: correlation with bone mineral density and biomechanical properties.

RATIONALE AND OBJECTIVES: The authors used direct magnification radiographs, combines with texture analysis, to investigate the trabecular structure of human vertebral specimens and compared these techniques with measurement of bone mineral density (BMD) by using quantitative computed tomography to predict bone strength. METHODS: Direct magnification radiographs and BMD measurements were obtained from 38 motion segments from the thoracolumbar spines of 11 female human cadavers. Maximum compressive strength (MCS) was determined with a materials testing machine. Morphologic parameters, digital skeletons, and fractal dimension were obtained from the radiographs in three different regions of interest. RESULTS: Correlations between BMD and MCS were statistically significant (r = .81, P < .01). With morphologic parameters, correlation coefficients of up to .64 (P < .01) were obtained. Use of multivariate regression analysis with one morphologic parameter (the width of the black pixels, or thicknessB) in addition to BMD improved correlations versus MCS (P < .01). CONCLUSION: In an experimental setting, BMD showed statistically significant correlation with bone strength, whereas the structural parameters demonstrated only modest correlations. BMD together with one of these measures (thicknessB), however, showed the highest correlation.

Adult↗