Search PubMed⌕ Search

Biomedical subjects

Harry K Genant

Publications and source records attributed to Harry K Genant.

63 records · Page 4Linked to original sources

Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: four-year results from a randomized clinical trial.

The Multiple Outcomes of Raloxifene Evaluation trial studied 7705 postmenopausal women with osteoporosis randomized to placebo, or raloxifene 60 or 120 mg/d [JAMA 282(1999): 637]. This report assesses the efficacy of raloxifene on the long-term cumulative incidence new vertebral fractures through 4 yr. New vertebral fractures was assessed from radiographs taken at baseline, yr 2-4. The primary analysis was the cumulative incidence of new vertebral fractures through 4 yr. A posthoc analysis compared the vertebral fracture risk in yr 4 alone with that observed in the first 3 yr. The 4-yr cumulative relative risks (RR) for one or more new vertebral fractures were 0.64 [95% confidence interval (CI) 0.53, 0.76] with raloxifene 60 mg/d and 0.57 (95% CI 0.48, 0.69) with raloxifene 120 mg/d. In yr 4 alone, raloxifene 60 mg/d reduced the new vertebral fracture risk by 39% [RR 0.61 (95% CI 0.43, 0.88)], which was not found to be significantly different from the RR observed in the first 3 yr in both raloxifene groups, irrespective of prevalent fracture status. The nonvertebral fracture risk was not significantly reduced [RR 0.93 (95% CI 0.81, 1.06)]. The safety profile after 4 yr was similar to that observed after 3 yr. Raloxifene 60 and 120 mg/d through 4 yr decreased the cumulative risk of new vertebral fractures in postmenopausal women with osteoporosis. The decreased vertebral fracture risk in yr 4 alone was not different from that observed in the first 3 yr.

Aged↗

Universal standardization of forearm bone densitometry.

As part of an effort to quantify device-dependent differences in forearm bone density, 101 women, aged 20-80 years (approximately 16 women in each age decade), were scanned on six forearm bone densitometers: the Aloka DCS-600EX, the Hologic QDR-4500A, the Lunar PIXI, the Norland pDEXA, the Osteometer DTX-200, and the Pronosco X-posure System. Regression statistics are reported for all similar regions of interest (ROIs). However, comparisons were confounded because of large differences in the ROI size and placement. The number of ROIs reported for a single scan by each device varied from 1 to 12. The correlation coefficients ranged from 0.7 < r < 0.97, with the highest correlation coefficients and lowest SEs for comparisons between the most similar ROIs. Standardized units of bone mineral density are derived for distal (sdBMD), mid-(smBMD), and proximal (spBMD) ROTs that allow for comparable mean bone densities to be derived for patient populations. Five phantoms were scanned and characterized on five of the devices and the precision and mean values were reported. These phantom values will aid in the in vitro cross-calibration between manufacturers to recreate the presented in vivo relationships. Care should be exercised when using these equations for cross-calibrating patient databases or pooling clinical data from different devices because the least significant differences detectable from measurements taken on two different machines can be increased substantially.

Absorptiometry, Photon↗

North American male reference population for speed of sound in bone at multiple skeletal sites.

Alternatives to dual-energy X-ray absorptiometry (DXA) have been sought to increase access to low-cost osteoporosis risk assessment. Early quantitative ultrasound (QUS) systems measured speed of sound (SOS) and broadband ultrasound attenuation (BUA) at the calcaneus, and these were demonstrated to be good predictors of hip fracture risk. Recent studies have demonstrated the usefulness of other peripheral sites to assess bone status. The Sunlight Omnisense (Sunlight Medical, Rehovot, Israel) is a portable, inexpensive QUS device capable of multiple-site SOS measurement. To provide a robust male reference database, 588 healthy Caucasian males aged 20-90 yr were recruited from 6 centers across North America. SOS measurements were taken at the distal 1/3 radius, proximal third phalanx, midshaft tibia, and fifth metatarsal. A female reference database has previously been collected at North American sites. The results indicate that SOS in males exhibits an age-related decline beginning in the fifth decade at the radius, phalanx, and metatarsal, whereas the tibial SOS remains nearly constant until the ninth decade. Although females reach a higher-peak SOS than males at most sites, SOS is higher in males at all sites after the sixth decade, as a result of a more gradual decline in SOS. Longitudinal monitoring of healthy men should be performed to confirm these cross-sectional results.

Adult↗

Discrepancy in results between spine and hip scans of a woman with end stage renal disease.

Conditions and artifacts such as aortic calcifications, osteophytes, hip prostheses, and metallic objects can affect the results of dual X-ray absorptiometry scans of the spine and hip. Abdominal surgery often entails the use of metal sutures causing subtle artifacts near or over the lumbar spine resulting in inaccurate bone mineral density (BMD) measurements. We herein report a case of a woman whose spine BMD appeared normal while her hip BMD was > -3.5 SDs. Although the abdominal artifacts create some uncertainty in the diagnosis, renal osteodystrophy is suspect owing to the patient's renal history. This case demonstrates the importance of acquiring scans at two or more sites, closely evaluating scans for artifacts, and obtaining the patient's medical history.

Absorptiometry, Photon↗

Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients.

BACKGROUND: The treatment of open fractures of the tibial shaft is often complicated by delayed union and nonunion. The objective of this study was to evaluate the safety and efficacy of the use of recombinant human bone morphogenetic protein-2 (rhBMP-2; dibotermin alfa) to accelerate healing of open tibial shaft fractures and to reduce the need for secondary intervention. METHODS: In a prospective, randomized, controlled, single-blind study, 450 patients with an open tibial fracture were randomized to receive either the standard of care (intramedullary nail fixation and routine soft-tissue management [the control group]), the standard of care and an implant containing 0.75 mg/mL of rhBMP-2 (total dose of 6 mg), or the standard of care and an implant containing 1.50 mg/mL of rhBMP-2 (total dose of 12 mg). The rhBMP-2 implant (rhBMP-2 applied to an absorbable collagen sponge) was placed over the fracture at the time of definitive wound closure. Randomization was stratified by the severity of the open wound. The primary outcome measure was the proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve months postoperatively. RESULTS: Four hundred and twenty-one (94%) of the patients were available for the twelve-month follow-up. The 1.50-mg/mL rhBMP-2 group had a 44% reduction in the risk of failure (i.e., secondary intervention because of delayed union; relative risk = 0.56; 95% confidence interval = 0.40 to 0.78; pairwise p = 0.0005), significantly fewer invasive interventions (e.g., bone-grafting and nail exchange; p = 0.0264), and significantly faster fracture-healing (p = 0.0022) than did the control patients. Significantly more patients treated with 1.50 mg/mL of rhBMP-2 had healing of the fracture at the postoperative visits from ten weeks through twelve months (p = 0.0008). Compared with the control patients, those treated with 1.50 mg/mL of rhBMP-2 also had significantly fewer hardware failures (p = 0.0174), fewer infections (in association with Gustilo-Anderson type-III injuries; p = 0.0219), and faster wound-healing (83% compared with 65% had wound-healing at six weeks; p =0.0010). CONCLUSIONS: The rhBMP-2 implant was safe and, when 1.50 mg/mL was used, significantly superior to the standard of care in reducing the frequency of secondary interventions and the overall invasiveness of the procedures, accelerating fracture and wound-healing, and reducing the infection rate in patients with an open fracture of the tibia.

Adolescent↗

Perthes lesion (a variant of the Bankart lesion): MR imaging and MR arthrographic findings with surgical correlation.

OBJECTIVE: The aim of this study was to evaluate the use of MR imaging in the characterization of the Perthes lesion by correlating MR findings with findings at arthroscopy. CONCLUSION: The use of a combination of axial and abduction-external rotation position sequences on MR images can be helpful in the diagnosis of a Perthes lesion. A fluid-filled joint with capsular distension, caused by either a large amount of effusion or MR arthrography, was found to be helpful in outlining Perthes lesions. Adding the abduction-external rotation position to the protocol in patients in whom Perthes lesion is suspected will increase diagnostic accuracy and may reveal a Perthes lesion not visible on axial images, as was the case in 50% of the patients in our series.

Adolescent↗

Classification algorithms for hip fracture prediction based on recursive partitioning methods.

This article presents 2 modifications to the classification and regression tree. The authors improved the robustness of a split in the test sample approach and developed a cost-saving classification algorithm by selecting noninferior to the optimum splits from variables with lower cost or being used in parent splits. The new algorithm was illustrated by 43 predictive variables for 5-year hip fracture previously documented in the Study of Osteoporotic Fractures. The authors generated the robust optimum classification rule without consideration of classification variable costs and then generated an alternative cost-saving rule with equivalent diagnostic utility. A 6-fold cross-validation study proved that the cost-saving alternative classification is statistically noninferior to the optimal one. Their modified classification and regression tree algorithm can be useful in clinical applications. A dual X-ray absorptiometry hip scan and information from clinical examinations can identify subjects with elevated 5-year hip fracture risk without loss of efficiency to more costly and complicated algorithms.

Absorptiometry, Photon↗