The prevalence of radiographic vertebral fractures in Latin American countries: the Latin American Vertebral Osteoporosis Study (LAVOS).

UNLABELLED: In the first population-based study of vertebral fractures in Latin America, we found a 11.18 (95% CI 9.23-13.4) prevalence of radiographically ascertained vertebral fractures in a random sample of 1,922 women from cities within five different countries. These figures are similar to findings from studies in Beijing, China, some regions of Europe, and slightly lower than those found in the USA using the same standardized methodology. INTRODUCTION: We report the first study of radiographic vertebral fractures in Latin America. METHODS: An age-stratified random sample of 1,922 women aged 50 years and older from Argentina, Brazil, Colombia, Mexico, and Puerto Rico were included. In all cases a standardized questionnaire and lateral X-rays of the lumbar and thoracic spine were obtained after informed consent. RESULTS: A standardized prevalence of 11.18 (95% CI 9.23-13.4) was found. The prevalence was similar in all five countries, increasing from 6.9% (95% CI 4.6-9.1) in women aged 50-59 years to 27.8% (95% CI 23.1-32.4) in those 80 years and older (p for trend < 0.001). Among different risk factors, self-reported height loss OR = 1.63 (95% CI: 1.18-2.25), and previous history of fracture OR = 1.52 (95% CI: 1.14-2.03) were significantly (p < 0.003 and p < 0.04 respectably) associated with the presence of radiographic vertebral fractures in the multivariate analysis. In the bivariate analyses HRT was associated with a 35% lower risk OR = 0.65 (95% CI: 0.46-0.93) and physical activity with a 27% lower risk of having a vertebral fracture OR = 0.73 (95% CI: 0.55-0.98), but were not statistically significant in multivariate analyses CONCLUSION: We conclude that radiographically ascertained vertebral fractures are common in Latin America. Health authorities in the region should be aware and consider implementing measures to prevent vertebral fractures.

A novel DXA-based hip failure index captures hip fragility independent of BMD.

Capability of a novel dual-energy X-ray absorptiometry (DXA)-based hip failure index (HiFI) to discriminate between hip fracture cases and controls was evaluated. Given the constraints of planar DXA, the femoral neck was assumed a foam-filled ( approximately trabecular bone), thin-walled ( approximately cortical bone) sandwich structure, while HiFI estimated the critical force sufficient to buckle the wall of such a structure. Proximal femur DXA data from 1379 women aged 65yr and older, 268 with prior hip fracture were used. Comparison between standard areal bone mineral density (BMD), femur strength index (FSI), and HiFI was based on areas under receiver operatoring characteristic curves (AUC). The mean femoral neck BMD (SD) was 0.689 (0.109) g/cm(2) among the cases and 0.768 (0.119) g/cm(2) among the controls; the mean FSI 1.33 (0.36) and 1.54 (0.41), and the mean HiFI -0.28 (0.14) and -0.18 (0.15), respectively; all intergroup differences were highly significant (p<0.001). The intergroup difference for HiFI remained significant (p<0.002) after adjusting for age and BMD or FSI. The AUCs were 0.696 (95% confidence interval [CI]: 0.661-0.730) for BMD, 0.665 (0.630-0.700) for FSI, and 0.701 (0.666-0.736) for HiFI. In conclusion, HiFI may capture structural traits that account for femoral neck fragility independently of BMD or FSI. Obviously, the use of actual geometric and structural information from three-dimensional imaging of the femoral neck would help diminish the crude assumptions of the present DXA approach and reveal the true potential of the HiFI approach to gauge hip fragility and identify at-risk individuals for hip fractures.

Disintegration/dissolution profiles of copies of Fosamax (alendronate).

OBJECTIVE: Poor quality has been reported for some generics and other copies of original products. We performed a pilot study to compare the disintegration/dissolution profiles of FOSAMAX (alendronate) 70 mg tablets with those of copies of FOSAMAX that were manufactured outside the United States. RESEARCH DESIGN AND METHODS: We used the standard United States Pharmacopeia (USP) disintegration method to evaluate FOSAMAX 70 mg tablets and 13 copies. At least 12 (n = 12) dosage units were tested for each product (except Fosmin, n = 10). The dissolution profiles of FOSAMAX and one representative copy were also compared. RESULTS: Nine copies (Osteomax, Defixal, Fosmin, Endronax, Osteomix, Genalmen, Fixopan, Osteoplus, and Fosval) disintegrated two- to ten-fold faster than FOSAMAX. Three other copies (Neobon, Regenesis, and Ostenan) disintegrated at least five-fold slower than FOSAMAX. Neobon is a softgel capsule, so special consideration was given to this different dosage form. One copy (Arendal) did not fall into either category but exhibited potentially large inter- and intra-lot variability. Dissolution of alendronate from Regenesis lagged behind that from FOSAMAX. CONCLUSION: Slower disintegration may reduce efficacy because bisphosphonates must be taken in the fasting state and contact with food or even certain beverages severely reduces bioavailability. Faster disintegration (or the use of gel-caps or other alterations to the drug formulation) could increase the risk of esophagitis, an adverse event associated with prolonged contact of the esophagus with bisphosphonates. These disintegration and dissolution results suggest that important differences may exist between FOSAMAX and its copies with regard to bioavailability, pharmacokinetics, and clinical efficacy and safety profiles. Additional testing is warranted to evaluate the pharmacokinetics and clinical safety of these copies.

Femur strength index predicts hip fracture independent of bone density and hip axis length.

INTRODUCTION: Proximal femoral bone strength is not only a function of femoral bone mineral density (BMD), but also a function of the spatial distribution of bone mass intrinsic in structural geometric properties such as diameter, area, length, and angle of the femoral neck. Recent advancements in bone density measurement include software that can automatically calculate a variety of femoral structural variables that may be related to hip fracture risk. The purpose of this study was to compare femoral bone density, structure, and strength assessments obtained from dual-energy X-ray absorbtiometry (DXA) measurements in a group of women with and without hip fracture. METHODS: DXA measurements of the proximal femur were obtained from 2,506 women 50 years of age or older, 365 with prior hip fracture and 2,141 controls. In addition to the conventional densitometry measurements, structural variables were determined using the Hip Strength Analysis program, including hip axis length (HAL), cross-sectional moment of inertia (CSMI), and the femur strength index (FSI) calculated as the ratio of estimated compressive yield strength of the femoral neck to the expected compressive stress of a fall on the greater trochanter. RESULTS: Femoral neck BMD was significantly lower and HAL significantly higher in the fracture group compared with controls. Mean CSMI was not significantly different between fracture patients and controls after adjustment for BMD and HAL. FSI, after adjustment for T score and HAL, was significantly lower in the fracture group, consistent with a reduced capacity to withstand a fall without fracturing a hip. CONCLUSION: We conclude that BMD, HAL, and FSI are significant independent predictors of hip fracture.