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P D Miller

Publications and source records attributed to P D Miller.

At least 19 recordsLinked to original sources

Standards and guidelines for performing central dual X-ray densitometry from the Canadian panel of International Society for Clinical Densitometry.

The International Society for Clinical Densitometry (ISCD) is a multidisciplinary nonprofit global organization formed to ensure excellence in densitometry imaging, interpretation, and application. The Canadian panel of the ISCD represents ISCD in Canada and oversees Canadian bone densitometry certification programs. The standards of care from the Canadian panel of the ISCD have been developed in order to establish the minimum level of acceptable performance for the practice of bone densitometry in Canada. A variety of techniques are available for skeletal assessment of bone mineral density, which vary in accuracy, precision, and clinical utility as well as availability. This article focuses on central dual X-ray absorptiometry in adults and does not address densitometry in the pediatric population. Other technologies will be addressed in a subsequent article.

Absorptiometry, Photon↗

Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment.

CONTEXT: Large segments of the population at risk for osteoporosis and fracture have not been evaluated, and the usefulness of peripheral measurements for short-term prediction of fracture risk is uncertain. OBJECTIVES: To describe the occurrence of low bone mineral density (BMD) in postmenopausal women, its risk factors, and fracture incidence during short-term follow-up. DESIGN: The National Osteoporosis Risk Assessment, a longitudinal observational study initiated September 1997 to March 1999, with approximately 12 months of subsequent follow-up. SETTING AND PARTICIPANTS: A total of 200 160 ambulatory postmenopausal women aged 50 years or older with no previous osteoporosis diagnosis, derived from 4236 primary care practices in 34 states. MAIN OUTCOME MEASURES: Baseline BMD T scores, obtained from peripheral bone densitometry performed at the heel, finger, or forearm; risk factors for low BMD, derived from questionnaire responses; and clinical fracture rates at 12-month follow-up. RESULTS: Using World Health Organization criteria, 39.6% had osteopenia (T score of -1 to -2.49) and 7.2% had osteoporosis (T score </=-2.5). Age, personal or family history of fracture, Asian or Hispanic heritage, smoking, and cortisone use were associated with significantly increased likelihood of osteoporosis; higher body mass index, African American heritage, estrogen or diuretic use, exercise, and alcohol consumption significantly decreased the likelihood. Among the 163 979 participants with follow-up information, osteoporosis was associated with a fracture rate approximately 4 times that of normal BMD (rate ratio, 4.03; 95% confidence interval [CI], 3.59-4.53) and osteopenia was associated with a 1.8-fold higher rate (95% CI, 1.49-2.18). CONCLUSIONS: Almost half of this population had previously undetected low BMD, including 7% with osteoporosis. Peripheral BMD results were highly predictive of fracture risk. Given the economic and social costs of osteoporotic fractures, strategies to identify and manage osteoporosis in the primary care setting need to be established and implemented.

Absorptiometry, Photon↗

Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group.

BACKGROUND: Risedronate increases bone mineral density in elderly women, but whether it prevents hip fracture is not known. METHODS: We studied 5445 women 70 to 79 years old who had osteoporosis (indicated by a T score for bone mineral density at the femoral neck that was more than 4 SD below the mean peak value in young adults [-4] or lower than -3 plus a nonskeletal risk factor for hip fracture, such as poor gait or a propensity to fall) and 3886 women at least 80 years old who had at least one nonskeletal risk factor for hip fracture or low bone mineral density at the femoral neck (T score, lower than -4 or lower than -3 plus a hip-axis length of 11.1 cm or greater). The women were randomly assigned to receive treatment with oral risedronate (2.5 or 5.0 mg daily) or placebo for three years. The primary end point was the occurrence of hip fracture. RESULTS: Overall, the incidence of hip fracture among all the women assigned to risedronate was 2.8 percent, as compared with 3.9 percent among those assigned to placebo (relative risk, 0.7; 95 percent confidence interval, 0.6 to 0.9; P=0.02). In the group of women with osteoporosis (those 70 to 79 years old), the incidence of hip fracture among those assigned to risedronate was 1.9 percent, as compared with 3.2 percent among those assigned to placebo (relative risk, 0.6; 95 percent confidence interval, 0.4 to 0.9; P=0.009). In the group of women selected primarily on the basis of nonskeletal risk factors (those at least 80 years of age), the incidence of hip fracture was 4.2 percent among those assigned to risedronate and 5.1 percent among those assigned to placebo (P=0.35). CONCLUSIONS: Risedronate significantly reduces the risk of hip fracture among elderly women with confirmed osteoporosis but not among elderly women selected primarily on the basis of risk factors other than low bone mineral density.

Aged↗

Tolerability of risedronate in postmenopausal women intolerant of alendronate.

Bisphosphonates are effective treatments for osteoporosis, but some have been associated with upper gastrointestinal intolerance. This randomized, double-blind study assessed the upper gastrointestinal tolerability of risedronate in postmenopausal women who had discontinued alendronate treatment because of upper gastrointestinal adverse events. Sixty-six women who had previously discontinued treatment with alendronate 10 mg/day because of upper gastrointestinal symptoms received placebo (N=31) or risedronate 5 mg (N=35) daily for 3 months. The primary outcome was the rate of discontinuation due to upper gastrointestinal adverse events: 5/31 (16.1%) in the placebo group, and 4/35 (11.4%) in the risedronate group. Discontinuation rates were also similar in the two treatment groups among subgroups of patients with a history of gastrointestinal disorder, prior use of acid suppression drugs, and concomitant use of NSAIDs. The overall incidence of upper gastrointestinal events was comparable between the placebo (19.4%) and risedronate (20.0%) groups. Overall, risedronate 5 mg/day for 3 months was as well tolerated as placebo in patients who could not tolerate alendronate 10 mg. These results are consistent with, and complement those from previous studies showing that risedronate 5 mg has a gastrointestinal tolerability similar to that of placebo.

Alendronate↗

Bisphosphonates for the prevention and treatment of corticosteroid-induced osteoporosis.

Corticosteroid-induced osteoporosis is a common occurrence among several different patient populations, including individuals undergoing therapy for rheumatoid arthritis, temporal arteritis, polymyalgia rheumatica, chronic lung disease, asthma and organ transplantation. The clinical trial data reviewed here demonstrate that bisphosphonate therapy can reverse, at least in part, established corticosteroid-induced osteoporosis, increase BMD, and prevent the development of new fractures. The consistency of results, with varying treatment regimens and in slightly different patient populations, provides strong support for the generalizability of these findings and for the use of bisphosphonates in corticosteroid-induced osteoporosis. These results are consistent with the findings from a recent meta-analysis, which reviewed data from 13 controlled clinical trials of bisphosphonate use in corticosteroid-induced osteoporosis. In that analysis, 1 year of bisphosphonate therapy produced a significant increase in BMD at the lumbar spine (average difference in BMD between treated and control groups of 4.0%) and femoral neck (average BMD difference of 2.1% between treated and control patients). Bisphosphonate therapy, therefore, appears to be an effective, well-tolerated means of reducing the risk of bone fractures among patients treated with corticosteroids.

Bone Density↗

Clinical performance of a highly portable, scanning calcaneal ultrasonometer.

The aim of this study was to establish a normative database, assess precision, and evaluate the ability to identify women with low bone mass and to discriminate women with fracture from those without for a highly portable, scanning calcaneal ultrasonometer: the QUS-2. Fourteen hundred and one Caucasian women were recruited for the study. Among them were 794 healthy women 25-84 years of age evenly distributed per 10-year period to establish a normative database. Of these, 171 aged 25-34 years were defined as the young normal group for the purpose of T-score determination. Precision was assessed within 1 day (short-term) and over a 16-week period (long-term) in 79 women aged 25-84 years. Five hundred twenty-eight women ranging from 50 to 84 years of age with or without prevalent fractures of the spine, hip or forearm were measured to compare the QUS-2 with bone mineral density (BMD) of the hip and spine. Mean calcaneal broadband ultrasound attenuation (BUA) was constant in healthy women from 25 to 54 years of age and decreased with increasing age thereafter. Short-term precision, with and without repositioning of the heel, and long-term precision yielded comparable results (BUA SDs of 2.1-2.4 dB/MHz, coefficients of variations (CVs) of 2.5-2.9%). Calcaneal BUA was significantly correlated with BMD of the total hip (TH), femoral neck (FN) and lumbar spine (LS) in 698 women (r = 0.6-0.7, all p < 0.0001). A similar relationship was observed for LS BMD compared with either TH or FN BMD (r = 0.7, p < 0.0001). Prevalence of osteoporosis in our population (WHO criteria) was 20%, 17%, 21%, and 24% for BUA, BMD of the TH, FN and LS, respectively. Age-adjusted values for a 1 SD reduction in calcaneal BUA and TH and FN BMD predicted prevalent fractures of the spine, forearm, and hip with significant (p < 0.05) odds ratios of 2.3, 2.0 and 2.1, respectively. Areas under the receiver operating characteristic curves for age-adjusted bone mass values predicting prevalent fracture were 0.62 for BUA, 0.59 for TH BMD, 0.60 for FN BMD, and 0.57 for LS BMD; all statistically equivalent. We conclude that the QUS-2 calcaneal ultrasonometer exhibits reproducible clinical performance that is similar to BMD of the spine and hip in identifying women with low bone mass and discriminating women with fracture from those without.

Adult↗

Traumatic grief in a convenience sample of victims seeking support services after a terrorist incident.

This report describes traumatic grief in 40 individuals who suffered losses in the 1995 bombing of the Alfred P. Murrah Federal Building in Oklahoma City. We administered a self-report instrument 6 months after the bombing to assess demographics; exposure; injury; retrospective report of initial emotional and physiological reaction; and current posttraumatic stress symptoms, grief, safety concerns, and functioning. A strong association was found between posttraumatic stress symptoms and grief. The relationship between grief and difficulty functioning was stronger at higher levels of posttraumatic stress than at lower levels. The results support the construct of traumatic grief and have important implications for the treatment of people exposed to large-scale traumatic events and for the training of mental health professionals.

Adult↗

Bisphosphonates: safety and efficacy in the treatment and prevention of osteoporosis.

Osteoporosis affects more than 28 million Americans. With the advent of accessible and affordable diagnostic studies, awareness and recognition of this disease by patients and clinicians are growing. Osteoporotic fractures of the spine and hip are costly and associated with significant morbidity and mortality. Over the past decade, a surge of new antiosteoporotic drugs have been labeled or are awaiting labeling by the U.S. Food and Drug Administration. One class of agents used to treat osteoporosis is the bisphosphonates, which inhibit bone resorption, cause an increase in bone mineral density and reduce the risk of future fractures caused by aging, estrogen deficiency and corticosteroid use. Overall, bisphosphonates have been shown to have a strong safety and tolerability profile.

Alendronate↗

Rechallenge of patients who had discontinued alendronate therapy because of upper gastrointestinal symptoms.

BACKGROUND: There have been reports from physicians in clinical practice that up to 30% of patients taking bisphosphonate therapy develop upper gastrointestinal (UGI) symptoms, many or most of which they assume to be related to the drug. However, in several large placebo-controlled clinical trials of bisphosphonates, the incidence of UGI symptoms has been > or =30%, even among patients receiving placebo, perhaps reflecting a high background incidence of UGI events in osteoporotic patients. OBJECTIVE: To assess the relationship between alendronate treatment and UGI complaints in patients who had discontinued treatment with alendronate in clinical practice because of UGI symptoms, we compared the incidence of such events on rechallenge with alendronate or placebo. METHODS: This was a multicenter, double-blind trial in which postmenopausal women with osteoporosis who had previously discontinued alendronate therapy because of a UGI adverse experience were randomized to daily treatment with either alendronate 10 mg or matching placebo (1:1 ratio) for 8 weeks. The primary end point was the cumulative incidence of discontinuations due to any UGI adverse experience. Secondary end points were the incidence of any clinical adverse experiences and the percentage change from baseline in urinary N-telopeptide adjusted for urinary creatinine at week 8. RESULTS: A total of 172 women were included in the study. They were a mean of 20.9 years past menopause, ranging in age from 41 to 90 years (mean, 67.0 years); 90.7% were white. On rechallenge, 14.8% (13/88) of patients in the alendronate group and 16.7% (14/84) in the placebo group discontinued treatment because of UGI adverse experiences. CONCLUSION: The results of this study suggest that many UGI adverse experiences reported during therapy with alendronate may reflect a high background incidence of UGI complaints and an increased sensitivity to detection of such complaints, rather than a causal relationship to therapy.

Alendronate↗

Posttraumatic stress two years after the Oklahoma City bombing in youths geographically distant from the explosion.

This article describes Posttraumatic Stress Disorder (PTSD) symptomatology in 69 sixth-grade youths who resided within 100 miles of Oklahoma City at the time of the 1995 bombing of the Alfred P. Murrah Federal Building. These youths neither had any direct physical exposure nor personally knew anyone killed or injured in the explosion. A survey conducted two years after the bombing assessed exposure, PTSD symptoms, and functioning. PTSD symptom frequency was measured with the Impact of Event Scale--Revised. Our BCD criteria for defining PTSD caseness was modeled after DSM-IV B, C, and D criteria requiring one reexperiencing, three avoidance/numbing, and two arousal symptoms for diagnosis. Those who met our BCD criteria had significantly higher PTSD symptom scores than those who did not. Both increased mean PTSD symptom score and meeting our caseness definition were associated with increased functioning difficulties. Media exposure and indirect interpersonal exposure (having a friend who knew someone killed or injured) were significant predictors of symptomatology. These findings suggest that children geographically distant from disaster who have not directly experienced an interpersonal loss report PTSD symptoms and functional impairment associated with increased media exposure and indirect loss.

Adolescent↗

Soliton interactions in perturbed nonlinear Schrödinger equations.

We use multiscale perturbation theory in conjunction with the inverse scattering transform to study the interaction of a number of solitons of the cubic nonlinear Schrödinger equation under the influence of a small correction to the nonlinear potential. We assume that the solitons are all moving with the same velocity at the initial instant; this maximizes the effect each soliton has on the others as a consequence of the perturbation. Over the long time scales that we consider, the soliton amplitudes remain fixed, while their center of mass coordinates obey Newton's equations with a force law for which we present an integral formula. For the interaction of two solitons with a quintic perturbation term we present more details since symmetries - one related to the form of the perturbation and one related to the small number of particles involved - allow the problem to be reduced to a one-dimensional one with a single parameter, an effective mass. The main results include calculations of the binding energy and oscillation frequency of nearby solitons in the stable case when the perturbation is an attractive correction to the potential and of the asymptotic "ejection" velocity in the unstable case. Numerical experiments illustrate the accuracy of the perturbative calculations and indicate their range of validity.

Journal Article↗

Antifracture efficacy of antiresorptive agents are related to changes in bone density.

There is a current debate about the extent to which antifracture efficacy of antiresorptive drugs are related to changes in bone mineral density (BMD). In vitro studies show that most of the variability in bone strength is related to BMD, and prospective studies have shown that low BMD is an important predictor of fracture risk. It seems that higher levels of bone turnover are also associated with increased fracture risk. Over the short term, a reduction in activation frequency or resorption depth would lead to fewer (and/or shallower) resorption sites and refilling of existing sites initially. There is also evidence that inhibiting resorption allows bone to respond to mechanical demands, preferentially thickening critical trabeculae, and this may help compensate for reduced connectivity. Each of these mechanisms would increase BMD and would disproportionately improve bone strength. Over the long term, maintaining bone mass and preventing loss of structural elements would result in progressively greater differences in BMD and fracture risk over time, relative to untreated women. The conceptual model predicts that both the short- and long-term antifracture efficacy of antiresorptive drugs will depend on the extent to which treatment can increase and maintain BMD. To examine this issue, we compiled data from clinical trials of antiresorptive agents and plotted the relative risk of vertebral fractures against the average change in BMD for each trial. The confidence intervals are large for individual trials, and there was substantial variability in antifracture efficacy at any given level of change in BMD. Overall, however, trials that reported larger increases in BMD tended to observe greater reductions in vertebral fracture risk. Poisson regression was used to quantify this relationship. The model predicts that treatments that increase spine BMD by 8% would reduce risk by 54%; most of the total effect of treatment was explained by the 8% increase in BMD (41% risk reduction). These findings are consistent with the short-term predictions of the conceptual model and with reports from randomized trials. The small but significant reductions in risk that were not explained by measurable changes in BMD might be related to publication bias, measurement errors, or limitations of current BMD technology.

Adult↗

The treatment of osteoporosis. Antiresorptive therapy.

Antiresorptive pharmacologic interventions for the prevention and treatment of osteoporosis are discussed. These interventions include estrogen; calcitonin; biphosphonates; and selective estrogen receptor modulators and their use in postmenopausal osteoporosis, steroid-induced osteoporosis, and osteoporosis in men. The effects of antiresorptive therapy on bone mineral density, biomarkers of bone turnover, and fracture risk are discussed.

Bone Density↗

Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group.

CONTEXT: Risedronate, a potent bisphosphonate, has been shown to be effective in the treatment of Paget disease of bone and other metabolic bone diseases but, to our knowledge, it has not been evaluated in the treatment of established postmenopausal osteoporosis. OBJECTIVE: To test the efficacy and safety of daily treatment with risedronate to reduce the risk of vertebral and other fractures in postmenopausal women with established osteoporosis. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled trial of 2458 ambulatory postmenopausal women younger than 85 years with at least 1 vertebral fracture at baseline who were enrolled at 1 of 110 centers in North America conducted between December 1993 and January 1998. INTERVENTIONS: Subjects were randomly assigned to receive oral treatment for 3 years with risedronate (2.5 or 5 mg/d) or placebo. All subjects received calcium, 1000 mg/d. Vitamin D (cholecalciferol, up to 500 IU/d) was provided if baseline levels of 25-hydroxyvitamin D were low. MAIN OUTCOME MEASURES: Incidence of new vertebral fractures as detected by quantitative and semiquantitative assessments of radiographs; incidence of radiographically confirmed nonvertebral fractures and change from baseline in bone mineral density as determined by dual x-ray absorptiometry. RESULTS: The 2.5 mg/d of risedronate arm was discontinued after 1 year; in the placebo and 5 mg/d of risedronate arms, 450 and 489 subjects, respectively, completed all 3 years of the trial. Treatment with 5 mg/d of risedronate, compared with placebo, decreased the cumulative incidence of new vertebral fractures by 41 % (95% confidence interval [CI], 18%-58%) over 3 years (11.3 % vs 16.3%; P= .003). A fracture reduction of 65% (95% CI, 38%-81 %) was observed after the first year (2.4% vs 6.4%; P<.001). The cumulative incidence of nonvertebral fractures over 3 years was reduced by 39% (95% CI, 6%-61 %) (5.2 % vs 8.4%; P = .02). Bone mineral density increased significantly compared with placebo at the lumbar spine (5.4% vs 1.1 %), femoral neck (1.6% vs -1.2%), femoral trochanter (3.3% vs -0.7%), and midshaft of the radius (0.2% vs -1.4%). Bone formed during risedronate treatment was histologically normal. The overall safety profile of risedronate, including gastrointestinal safety, was similar to that of placebo. CONCLUSIONS: These data suggest that risedronate therapy is effective and well tolerated in the treatment of women with established postmenopausal osteoporosis.

Aged↗

Development and validation of the mini-osteoporosis quality of life questionnaire (OQLQ) in osteoporotic women with back pain due to vertebral fractures. Osteoporosis Quality of Life Study Group.

The objective of the study was to evaluate a shortened osteoporosis quality of life questionnaire (OQLQ) in osteoporotic women with back pain due to vertebral fractures. From the longer 30-item OQLQ (four to nine items per domain) we created the mini-OQLQ by choosing the two items with the highest impact in each of five domains (symptoms, physical function, activities of daily living, emotional function, leisure). We administered the OQLQ, the Sickness Impact Profile, the SF-36 and the Brief Pain Index to patients at baseline, after 2 weeks and after 6 months. The intraclass correlations between baseline and the 2-week follow-up for the five mini-OQLQ domains ranged from 0.72 to 0.86. Cross-sectional correlations between the domains of the mini-OQLQ and other health instruments were moderate to large (0.35-0.80) and greater than predicted. The mini-OQLQ items showed moderate to large correlations with items omitted from the shortened questionnaire (0. 44-0.88). Correlations between the OQLQ domains and the other three instruments were greater than those of the mini-OQLQ, and partial correlations between OQLQ items omitted from the mini-OQLQ and the other three instruments after considering mini-OQLQ items were substantial (0.19-0.71) and statistically significant. Sample sizes of less than 200 per group should be required to detect minimally important differences in parallel-group clinical trials. Longitudinal correlations between the mini-OQLQ and the other measures were often significant but generally lower than predicted (0.10-0.49). The partial correlations revealed that the omitted items explained a significant portion of the longitudinal variance in each domain. We conclude that in a selected group of patients with back pain caused by vertebral fractures, the mini-OQLQ demonstrated good discriminative and adequate evaluative properties. The mini-questionnaire should be useful in clinical settings.

Aged↗

A randomized, double-blind comparison of risedronate and etidronate in the treatment of Paget's disease of bone. Paget's Risedronate/Etidronate Study Group.

PURPOSE: To compare the efficacy and tolerability of oral risedronate and etidronate for treatment of Paget's disease of bone. PATIENTS AND METHODS: Patients from 12 centers in North America received risedronate 30 mg daily for 2 months (62 patients) or etidronate 400 mg daily for 6 months (61 patients) in a prospective, randomized, double-blind study. Serum alkaline phosphatase (the primary variable), serum bone-specific alkaline phosphatase, and urinary deoxypyridinoline concentrations were monitored for 12 to 18 months. RESULTS: Serum alkaline phosphatase concentration normalized by month 12 in 73% of risedronate-treated patients, compared with 15% of those receiving etidronate (P <0.001). Median time to normalization was 91 days for risedronate-treated patients and >360 days for etidronate-treated patients (P <0.001); relapse rates were 3% in the risedronate group and 15% in the etidronate group (P <0.05). At month 18, 53% of the risedronate group and 14% of the etidronate group remained in biochemical remission. Urinary deoxypyridinoline normalized in 87% of patients on risedronate and 57% of patients receiving etidronate (P <0.01); serum bone-specific alkaline phosphatase normalized in 73% of patients on risedronate and 18% of patients on etidronate (P <0.001). Patients who had received etidronate previously had a blunted response to etidronate, but not to risedronate. Reductions in pain were statistically significant in the risedronate group, but not in the etidronate group. Both drugs were well tolerated. CONCLUSION: Although etidronate is effective, risedronate offers a shorter duration of therapy, better and longer-lasting remission, significant reductions in pain, and provides additional remission in subjects who exhibited an incomplete response to previous etidronate treatment.

Administration, Oral↗