Official positions of the International Society for Clinical Densitometry.
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Bone Density↗
Biomedical subjects
Neil Binkley
Publications and source records attributed to Neil Binkley.
Official positions of the International Society for Clinical Densitometry and Executive Summary of the 2005 Position Development Conference.
The International Society for Clinical Densitometry (ISCD) convenes a Position Development Conference (PDC) every two years for the purpose of making recommendations on clinically relevant issues in bone densitometry. Topics for consideration are developed by the ISCD Scientific Advisory Committee and the PDC Steering Committee. Clinically relevant questions related to each topic area are assigned to subcommittees for a comprehensive medical literature review and presentation of a report to an international panel of experts. The expert panel includes representatives of the American Society for Bone and Mineral Research (ASBMR) and the International Osteoporosis Foundation (IOF). The recommendations of the PDC expert panel are evaluated by the ISCD Board of Directors, and those that are approved become Official Positions of the ISCD. The Official Positions have subsequently been endorsed by the ASBMR and IOF. The most recent PDC was held July 15-17, 2005, in Vancouver, BC, Canada. Topics considered included technical standardization, vertebral fracture assessment, and application of the 1994 World Health Organization (WHO) criteria to various skeletal sites and to populations other than postmenopausal white women. This report describes the methodology of the 2005 PDC and presents a summary of all ISCD Official Positions.
Absorptiometry, Photon↗
Vertebral fracture assessment: the 2005 ISCD Official Positions.
Vertebral Fracture Assessment (VFA) is a low radiation method for imaging the thoraco-lumbar spine using bone densitometers. VFA can easily be performed at the time of bone mineral density (BMD) measurement, allowing integration of BMD and vertebral fracture information into clinical patient care. As VFA is a relatively new procedure, it has received limited study and heretofore has not had widespread clinical application. Consequently, the International Society for Clinical Densitometry (ISCD) considered the following VFA issues at the 2005 Position Development Conference: (1) indications for VFA; (2) methodology for the diagnosis of vertebral fractures using VFA; and (3) indications for additional imaging after VFA. The ISCD Official Positions with respect to the above issues, as well as the rationale and evidence used to derive these positions, are presented here.
Absorptiometry, Photon↗
Calcium supplement ingestion may alter lumbar spine bone mineral density measurement.
Densitometry centers commonly request patients abstain from ingesting calcium supplements prior to dual-energy X-ray absorptiometry (DXA) examination to avoid interference with bone mineral density (BMD) measurement. However, it is not clear that this practice is necessary. This study assessed the impact of recent calcium supplement intake on lumbar spine BMD measurement. The phase 1 experiment demonstrated BMD differences when placing a supplement over various areas of two encapsulated phantoms. To determine whether these results were clinically relevant, the phase 2 study enrolled 36 subjects who received spine scans before and after random assignment to ingest one Citracal, OsCal or People's Choice tablet providing 315, 500, and 600 mg of elemental calcium, respectively. The phase 3 study evaluated 15 subjects that had three spine scans with repositioning between to establish BMD precision, and then ingested a calcium carbonate tablet. Post-dosing scans were performed 15 and 30 minutes after tablet ingestion. The difference in L1-L4 BMD on subsequent scans was compared with the study derived least significant change (LSC) of 0.028 g/cm(2). In phase 2, L1-L4 BMD changes outside the LSC occurred in 36% of subjects with 47% having visualized tablets. Similarly, 33% of the phase 3 subjects demonstrated changes outside the LSC after calcium ingestion and 53% of the subjects in phase 3 had tablets visualized. Visualization of calcium tablets was not associated with BMD changes. In conclusion, calcium tablet intake may affect measured L1-L4 BMD within 30 minutes of ingestion. As such, it is appropriate to request patients abstain from calcium tablet ingestion prior to a spine DXA examination.
Absorptiometry, Photon↗
Standards for performing DXA in individuals with secondary causes of osteoporosis.
This document addresses skeletal health assessment in individuals with secondary causes of osteoporosis. Recommendations are based on consensus of the Canadian Panel of the International Society for Clinical Densitometry and invited international experts. Bone mineral density (BMD) testing in these populations is performed in conjunction with careful evaluation of the disease state contributing to bone loss and increased fragility fracture risk, as well as assessment of other contributing risk factors for fracture. The presence of secondary causes of bone loss may further increase the risk of fracture independently of BMD and may necessitate earlier pharmacologic intervention. Dual-energy X-ray absorptiometry is indicated in the initial workup of secondary causes of osteoporosis. The BMD fracture risk relationship is not known for individuals with chronic renal failure (CRF). The BMD testing in this population may be normal in the presence of skeletal fragility, and quantitative bone histomorphometry is better at evaluating skeletal status than BMD in CRF. Dual-energy X-ray absorptiometry is a valuable tool in assessing skeletal health in individuals with secondary causes of osteoporosis.
Absorptiometry, Photon↗
HPLC method for 25-hydroxyvitamin D measurement: comparison with contemporary assays.
BACKGROUND: The concentration of 25-hydroxyvitamin D [25(OH)D] in serum has been designated the functional indicator of vitamin D (VitD) nutritional status. Unfortunately, variability among 25(OH)D assays limits clinician ability to monitor VitD status, supplementation, and toxicity. METHODS: We developed an HPLC method that selectively measures 25-hydroxyvitamin D2 [25(OH)D2] and D3 [25(OH)D3] and compared this assay with a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, a competitive protein-binding assay (CPBA) on the Nichols Advantage platform, and an RIA from Diasorin. RESULTS: For the new HPLC assay, between-run CVs were 2.6%-4.9% for 25(OH)D3 and 3.2%-13% for 25(OH)D2; recoveries were 95%-102%; and the assay was linear from 5 microg/L to at least 200 microg/L. Comparison data were as follows: for HPLC vs LC-MS/MS, y = 1.01x - 4.82 microg/L (Sy/x = 4.93 microg/L; r = 0.996) for 25(OH)D3, and y = 0.902x - 0.566 microg/L (Sy/x = 2.56 microg/L; r = 0.9965 for 25(OH)D2; for HPLC vs Diasorin RIA, y = 0.709x - 5.86 microg/L (Sy/x = 7.35 microg/L; r = 0.7509); and for HPLC vs Nichols Advantage CPBA, y = 1.00x - 3.60 microg/L (Sy/x = 32.7 microg/L; r = 0.6823). CONCLUSIONS: The new HPLC method is reliable, robust, and has advantages compared with the Nichols Advantage CPBA and the Diasorin RIA. The Nichols Advantage CPBA overestimated or underestimated 25(OH)D concentrations predicated on the prevailing metabolite present in patients' sera.
25-Hydroxyvitamin D 2↗
Serum retinyl esters are not elevated in postmenopausal women with and without osteoporosis whose preformed vitamin A intakes are high.
BACKGROUND: Recent observational studies suggest that preformed vitamin A (VA) intakes of 1500-2000 microg/d may increase the risk of osteoporosis and hip fracture. However, few studies have examined associations between biologic indicators of VA and osteoporosis. OBJECTIVE: This study characterized VA intake, serum VA, and bone turnover markers in postmenopausal women with and without osteoporosis. DESIGN: Bone density was measured by dual-energy X-ray absorptiometry. Subjects were separated into those with osteoporosis (n = 30) and those with normal bone density (n = 29). Women with osteopenia were excluded. Complete blood chemistries were obtained. Serum was analyzed for retinol, retinyl esters, and metabolites. Assays for 3 bone turnover markers were performed by using commercially available kits. Diet records were quantified. Logistic regression was used to test for an association between dietary and serum variables and osteoporosis. RESULTS: Dietary VA did not differ significantly between the groups but was nearly twice the Recommended Dietary Allowance in both groups. Body mass index (BMI) and serum triacylglycerols were significantly lower in the osteoporosis group. Retinyl esters were not elevated in either group, but a trend existed for the association of serum retinyl esters as a percentage of total VA with osteoporosis (P = 0.070) after adjustment for BMI and triacylglycerols in the statistical model. Milk, fruit, and vegetable intakes were below the current recommendations. CONCLUSIONS: Serum retinyl esters were not elevated in these postmenopausal women despite intakes of total VA that were nearly two-fold the Recommended Dietary Allowance. However, retinyl ester concentration (percentage of total VA) was marginally associated with osteoporosis and should be further investigated.
Absorptiometry, Photon↗
Bone density testing in older women and its association with patient age.
OBJECTIVES: To measure the early adoption of bone density testing and examine the association between older age and such testing. DESIGN: Retrospective study of Medicare administrative claims. SETTING: Five states and six urban regions in the United States. PARTICIPANTS: Female Medicare recipients aged 66 to 90. MEASUREMENTS: Bone density testing in women without prior osteoporosis or fracture (osteoporosis screening) was evaluated. The association between age and osteoporosis screening was then examined while controlling for other demographic and health factors. RESULTS: Of 43,802 women eligible for osteoporosis screening, 22.9% were tested between 1999 and 2001, the first 3 full years of Medicare coverage. Receipt of bone density tests decreased with increasing age, from 27.2% of women aged 66 to 70 to fewer than 10% of women aged 86 to 90. After adjustment for race, comorbidity, fracture risk, and socioeconomic factors, bone density testing decreased significantly with each age category, so that women aged 71 to 75 were slightly less likely than (adjusted odds ratio (AOR) =0.91, 95% confidence interval (CI) =0.86-0.96), women aged 76 to 80 were less likely than (AOR =0.71, 95% CI =0.67-0.76), and women aged 81 to 85 were half as likely as (AOR =0.50, 95% CI =0.46-0.55) women aged 66 to 70 to receive a bone density test. CONCLUSION: In the 3 years after Medicare reimbursement for osteoporosis screening began, adoption of bone density testing was lowest in women in age groups at highest fracture risk.
Absorptiometry, Photon↗
Laboratory reporting of 25-hydroxyvitamin D results: potential for clinical misinterpretation.
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25-Hydroxyvitamin D 2↗
Osteoporosis in men.
Osteoporosis is defined as "a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue with a consequent increase in bone fragility and susceptibility to fracture". Approximately 40-50% of women sustain osteoporotic fractures in their lifetime; as such, it is appropriate that studies initially focused upon females. Despite an increased recognition of osteoporotic fractures in men, there continues to be neglect of this disease in males. This ongoing neglect is inappropriate as 25-33% of men in some populations will sustain osteoporotic fractures in their lifetime. Testosterone plays an important role in male skeletal health. However, recent data suggest that estrogen may in fact be the dominant hormone regulating skeletal status in both men and women. BMD measurement may be utilized for osteoporosis diagnosis and to assist with fracture risk prediction in men prior to their sustaining a fracture. Recognizing this need, the International Society for Clinical Densitometry (ISCD) recommended and recently reaffirmed use of a BMD T-score of -2.5 or below be utilized to diagnose osteoporosis in men. Androgen therapy of hypogonadal men may be considered with the caveat that data do not exist to document that this treatment reduces fracture risk. At this time, the data is inadequate to support use of androgen treatment in eugonadal men with osteoporosis. Parathyroid hormone treatment does increase BMD; existing studies have not been of adequate size or duration to document fracture reduction efficacy. Bisphosphonate therapy increases BMD, reduces vertebral fracture risk and is considered the standard of care for osteoporotic men at this point in time.
Androgens↗
Position Development Conference of the International Society for Clinical Densitometry. Vancouver, BC, July 15-17, 2005.
Every 2 years the International Society for Clinical Densitometry (ISCD) organizes a position development conference at which a panel of experts reviews topics of interest in the field of bone densitometry and proposes Official Positions of the ISCD. In July 2005, the most recent conference was held in Vancouver, Canada, during which 4 topics were discussed: (1) Cross-calibration of dual energy x-ray absorptiometry (DXA) systems, (2) Vertebral fracture assessment, (3) World Health Organization (WHO) classification of bone density for populations other than postmenopausal women, and (4) WHO classification for varying skeletal sites. The Official Positions reached at this conference enumerated in this report have been published in The Journal of Clinical Densitometry, and can be found at www.iscd.org.
Absorptiometry, Photon↗
Lateral vertebral assessment: a valuable technique to detect clinically significant vertebral fractures.
Although many vertebral fractures are clinically silent, they are associated with increased risk for subsequent osteoporotic fractures. A substantial number of these fractures are demonstrable using instant vertebral assessment with Hologic densitometers. Whether similar recognition is possible using dual-energy lateral vertebral assessment (LVA) with GE Lunar densitometers remains uncertain. Thus, we evaluated the ability of clinicians using LVA to detect prevalent vertebral fractures. Dual-energy LVA and conventional thoracic and lumbar spine radiographs were concurrently obtained in 80 postmenopausal women. Using an established visual semiquantitative system, vertebral fractures were identified individually by two non-radiologist clinicians on LVA images, and the results were compared with spinal radiograph evaluation by an expert radiologist. Using LVA, 95% of vertebral bodies from T7 through L4 were evaluable, but a majority (66%) of vertebrae from T4 to T6 were not adequately visualized. In the LVA-evaluable vertebrae, prevalent fractures were identified in 40 vertebral bodies by radiography. In this regard, the clinicians using LVA detected 17 of 18 radiographically evident vertebral fractures of grade 2 or 3, a false negative rate of 6%. They identified 50% (11/22) of grade 1 fractures. Additionally, the vast majority of evaluable non-fractured vertebrae, (764/794, 96.2%) were correctly classified as normal by LVA. Thus, clinicians utilizing LVA correctly identified the vast majority of grade 2 or 3 vertebral compression fractures and normal vertebral bodies, although detection of grade 1 fractures was less effective. In conclusion, the low-radiation, dual-energy LVA technique provides a rapid and convenient way for clinicians to identify patients with, and without, grade 2 or 3 vertebral fractures, thereby enhancing care of osteoporotic patients.
Aged↗
Prevalence of Vitamin D inadequacy among postmenopausal North American women receiving osteoporosis therapy.
PURPOSE: To evaluate serum 25-hydroxyvitamin D [25(OH)D] concentrations and factors related to vitamin D inadequacy in postmenopausal North American women receiving therapy to treat or prevent osteoporosis. METHODS: Serum 25(OH)D and PTH were obtained in 1536 community-dwelling women between November 2003 and March 2004. Multivariate logistic regression was used to assess risk factors for suboptimal (<30 ng/ml) 25(OH)D. RESULTS: Ninety-two percent of study subjects were Caucasian, with a mean age of 71 yr. Thirty-five percent resided at or above latitude 42 degrees north, and 24% resided less than 35 degrees north. Mean (sd) serum 25(OH)D was 30.4 (13.2) ng/ml: serum 25(OH)D was less than 20 ng/ml in 18%; less than 25 ng/ml in 36%; and less than 30 ng/ml in 52%. Prevalence of suboptimal 25(OH)D was significantly higher in subjects who took less than 400 vs. 400 IU/d or more vitamin D. There was a significant negative correlation between serum PTH concentrations and 25(OH)D. Risk factors related to vitamin D inadequacy included age, race, body mass index, medications known to affect vitamin D metabolism, vitamin D supplementation, exercise, education, and physician counseling regarding vitamin D. CONCLUSIONS: More than half of North American women receiving therapy to treat or prevent osteoporosis have vitamin D inadequacy, underscoring the need for improved physician and public education regarding optimization of vitamin D status in this population.
Accidental Falls↗
Combination therapy for osteoporosis: considerations and controversy.
Combination therapy, the simultaneous use of two pharmaceutical agents with the goal being reduction of fracture risk, is an area of substantial clinical interest. This paper summarizes the rationale, existing clinical trials data, and other considerations relevant to combination therapy for osteoporosis. Combinations of antiresorbers (eg, estrogen plus bisphosphonates) produce greater increases in bone mass than either treatment alone. Conversely, combining anabolic agents (parathyroid hormone) with bisphosphonates does not produce additive effects. None of the existing studies are large enough to determine whether combination treatment reduces fracture risk to a greater extent than use of a single agent. However, it is certain that combination treatment will increase cost and likely that it will increase side effects and reduce therapy adherence. Given the absence of demonstrated fracture reduction benefit, increased cost and likely increase in adverse events, combination therapy is not currently recommended.
Alendronate↗
Combination therapy for osteoporosis: considerations and controversy.
Combination therapy, the simultaneous use of two pharmaceutical agents with the goal being reduction of fracture risk, is an area of substantial clinical interest. This paper summarizes the rationale, existing clinical trials data, and other considerations relevant to combination therapy for osteoporosis. Combinations of antiresorbers (eg, estrogen plus bisphosphonates) produce greater increases in bone mass than either treatment alone. Conversely, combining anabolic agents (parathyroid hormone) with bisphosphonates does not produce additive effects. None of the existing studies are large enough to determine whether combination treatment reduces fracture risk to a greater extent than use of a single agent. However, it is certain that combination treatment will increase cost and likely that it will increase side effects and reduce therapy adherence. Given the absence of demonstrated fracture reduction benefit, increased cost and likely increase in adverse events, combination therapy is not currently recommended.
Bone Resorption↗
A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis.
OBJECTIVE: This study evaluated the overall safety and tolerability of once-weekly (OW) alendronate 70 mg oral solution (OS) versus OW placebo OS. METHODS: Postmenopausal, osteoporotic women were enrolled at 51 centers in the United States in a 6-month double-blind, randomized trial. Patients were randomized (1:1) to OW alendronate 70 mg OS or placebo OS. The primary end point was the proportion of patients reporting any upper gastrointestinal (UGI) adverse event (AE) at 6 months. Secondary end points included mean percentage change in urinary N-telopeptide of type I human collagen (NTx) and serum bone-specific alkaline phosphatase (BSAP) at 6 months. RESULTS: Initially, 454 women were enrolled; 392 (86.3%) completed the study. The mean (SD) age was 65.2 (10) years, and the mean (SD) time since menopause was 19.1 (12) years. The proportion of patients experiencing any UGI AE was significantly higher with alendronate OS (23.7%) compared with placebo solution (15.3%), with a treatment difference of 8.3% (95% CI, 0.8%-15.8%; P = 0.024). The proportion of patients experiencing any esophageal AE was 4.0% with alendronate and 3.0% with placebo (treatment difference, 1.0% [95% CI, -2.7% to 4.8%]). In addition, 4.5% of alendronate and 8.7% of placebo patients discontinued the study due to any clinical AE, and 3.3% of alendronate and 1.8% of placebo patients discontinued due to a UGI AE (difference, 1.5% [95% CI, -1.5% to 4.4%]). Alendronate OS produced significantly greater reductions in both NTx and BSAP than placebo (differences, -47.5% and -38.7%, respectively [both, P < 0.001]). CONCLUSIONS: In this 6-month study, patients receiving OW alendronate 70 mg OS had a higher rate of UGI AEs than placebo patients. However, rates of serious UGI AEs, discontinuations due to UGI AEs, and esophageal AEs were similar between groups. UGI AEs in the study were generally mild to moderate in severity and did not result in treatment discontinuation. In addition, OW alendronate 70 mg OS significantly reduced biochemical markers of bone turnover.
Administration, Oral↗
Low bone mass prevalence and osteoporosis risk factor assessment in African American Wisconsin women.
BACKGROUND: Post-menopausal osteoporosis is seen in all racial groups. With the increasing population and longevity of minority groups, osteoporosis is becoming an important health concern. Data regarding risk factors for, and prevalence of, low bone mass and awareness of osteoporosis risk in African American (AA) women are limited. OBJECTIVE: This article evaluates the risk factors for, and prevalence of, low bone mass in a population of urban AA women in Wisconsin and assesses this group's perceived risk for osteoporosis. METHODS: One hundred fifty consecutive community-dwelling AA women > or = 45 years old from Milwaukee, Wis were asked to complete a questionnaire based on currently accepted osteoporosis risk factors. Additionally, their perception of osteoporosis risk was assessed using a Likert scale. All subjects underwent quantitative calcaneal ultrasound. RESULTS: Subject mean age was 54 +/- 7 years. Mean T- and Z-scores were 0.5 and 0.4, respectively. Applying World Health Organization criteria, osteopenia (bone mineral density T-score <-1.0) was present in 23.3% and osteoporosis (bone mineral density <-2.5) in 9.3%. Multivariate analysis of risk factors showed that lifetime incidence of at least 1 fracture, multiparity (>2 children), postmenopausal state, and current smoking were associated with lower calcaneal bone mass. Higher education and presence of diabetes were associated with a higher bone mass. Only 25% of the women surveyed thought they were at moderate to high risk for osteoporosis. CONCLUSIONS: Low bone mass was present in 33% of these AA women despite their relative young age. Many AA women do not perceive osteoporosis as a health risk. It is necessary to develop strategies to educate AA women regarding osteoporosis risk.
Black or African American↗
Interobserver reproducibility of criteria for vertebral body exclusion.
UNLABELLED: We studied reproducibility of the ISCD vertebral exclusion criteria among four interpreters. Surprisingly, agreement among interpreters was only moderate, because of differences in threshold for diagnosing focal structural defects and choice of which vertebra among a pair discordant for T-score, area, or BMC to exclude. Our results suggest that reproducibility may be improved by specifically addressing the sources of interobserver disagreement. INTRODUCTION: Although DXA is widely used to measure vertebral BMD, its interpretation is subject to multiple confounders including osteoarthritis, aortic calcification, and scoliosis. In an attempt to standardize interpretation and minimize the impact of artifacts, the International Society for Clinical Densitometry (ISCD) established criteria for vertebral exclusion, including the presence of a focal structural defect (FSD), discrepancy of >1 SD in T-score between adjacent vertebrae, and a lack of increase in BMC or area from L1 to L4. Whereas the efforts of the ISCD represent an important advance in BMD interpretation, the interobserver reproducibility with application of these criteria is unknown. We hypothesized that there would be substantial agreement among four interpreters regarding application of the exclusion criteria and the final lumbar spine T-score. MATERIALS AND METHODS: Each interpreter read a set of 200 lumbar DXA scans obtained on male veterans, applying the ISCD vertebral body exclusion criteria. RESULTS: Surprisingly, agreement among interpreters was only moderate. Differences in interpretation resulted from differing thresholds for recognition of FSD and the choice of excluding the upper or lower vertebral body for the criteria requiring comparison between adjacent vertebrae. CONCLUSIONS: Despite their apparent simplicity, the ISCD vertebral exclusion criteria are difficult to apply consistently. In principle, appropriate refinement of the exclusion criteria may significantly improve interobserver agreement.
Absorptiometry, Photon↗