Patterns of Clinical Care Subsequent to Nonindicated Vitamin D Testing in Primary Care.

BACKGROUND: Exponential increases in nonindicated, low-value vitamin D testing have been reported over the past 15 years. Downstream effects of such testing have not been well quantified. METHODS: The purpose of this study was to describe patterns of vitamin D testing within primary care of a large regional health system and to explore downstream health service utilization subsequent to nonindicated testing. Instances of vitamin D testing in 2015 were obtained by an electronic health record-automated search. A subset of patients for whom vitamin D testing was classified as nonindicated was identified, and vitamin D-related service utilization was tracked for 24 months. RESULTS: Of the 77,836 adult primary care patient records identified in 2015, vitamin D tests were conducted on 8,042 (10.3%), with 24.3% of tests yielding abnormal results. In the nonindicated test subset (n = 574), substantial clinical variability was illustrated by 85 care pathways and 26 vitamin D prescriptions. Forty-five percent of abnormal vitamin D lab tests were not followed up with repeat vitamin D tests. Vitamin D-related services (laboratory tests, imaging, and prescriptions) occurred at an average rate of 1.6 services per patient during the 24 months following nonindicated vitamin D testing. Some of these services were also classified as nonindicated. CONCLUSIONS: Evidence of a health service cascade following nonindicated vitamin D testing exists. Opportunities for improved consistency and quality of care related to vitamin D were observed in our health system. These results may inform clinical pathways related the prevention, evaluation, and treatment of low vitamin D.

Decreasing Trauma Readmission Rates by Implementing a Callback Program.

Decreasing hospital lengths of stay increases the burden on trauma patients after discharge. Our hypothesis was that a discharge callback protocol would decrease readmission rates. A retrospective quality improvement study evaluated all trauma patients admitted from 2012 to 2016 at a Level I trauma center. A postdischarge callback protocol was implemented in 2014, with a mature protocol in place in 2015. The precall and callback groups were compared regarding demographics, injury severity, and trauma readmission. Callback data included length of call, unsolicited patient comments, and education provided. Chi-square and Fisher's exact tests were used to compare categorical variables, whereas an independent-samples t test was used to compare continuous data. The precall program group included 4,470 admissions, and the call program group included 4,647 admissions. The precall program group had a higher injury severity score (ISS; 11.7 vs. 10.3; p < .001) and fewer males (62% vs. 65%, p = .002). In the call program group, there was a significant decrease in readmission rates (1.42% vs. 0.81%; p = .04). Patients with an unplanned readmission had a higher ISS (14.9 vs. 11.0, p < .01), a longer mean hospital length of stay during initial admission (9.3 days vs. 4.8 days, p < .01), and were more often discharged to locations with medical oversight (37.4% vs. 26.7%, p = .03). Of the patients in the call program group, 27.9% were reached. An average of 5.8 ± 2.9 min per call was calculated, equating to a 0.2 full-time equivalent. A discharge callback program for approximately 2,500 trauma patients per year leads to fewer readmissions, which financially supports the callback position.

Mental health research in the Arab world.

PURPOSE: To assess the progression of mental health research over four decades in the Arab world. METHODS: Publications on mental health in 21 Arab countries from 1966 to 2006 were screened using PubMed and Psychinfo. Data were collected and analyzed for Arab authors and affiliations, publication year, topic and type of journal. RESULTS: In 40 years (1966-2005), the Arab world published 2,213 articles on a vast variety of topics, most common being mood, anxiety and substance use disorders, and mostly in international journals. By the last decade, the total yearly publications increased about eightfold since the first two decades, and nearly doubled from the third one. The disparity of output was high across countries. The highest yearly output was from Egypt, Saudi Arabia, Kuwait and Lebanon. Per million population, the top four producing countries were Kuwait, Bahrain, Lebanon and United Arab Emirates. CONCLUSIONS: Over a decade, the Arab world produced approximately 17% of the global output of mental health publications/million population and was comparative to Latin American and Caribbean countries. There is a wide gap in comparison with the industrialized world, with a fertile ground for cross-cultural and genetic studies.

Treatment of mental disorders and pathways to care in Arab countries.

INTRODUCTION: The available studies on the treatment of mental disorders in the Arab world are uncommon. METHODS: A literature review was conducted aiming at identifying studies related to the rate and type of treatment of mental disorders in Arab countries from the Middle Eastern Mediterranean region. RESULTS: A total of 23 articles were included in this review. These articles focused mainly on type of services used and/ or the rate of treatment. Findings from several articles showed a paucity of treatment of mental disorders, and when present, individuals were more likely to receive it from the general medical than from the mental health sector. Only two studies have assessed patterns of treatment of mental disorders on a national level from the Arab Middle Eastern countries (Lebanon and Iraq). CONCLUSION: The need for national studies on mental disorders in this part of the world and the improvement of public awareness in this field were highlighted.

The role of anxious and hyperthymic temperaments in mental disorders: a national epidemiologic study.

Temperament has been demonstrated clinically to be linked to mental disorders. We aimed to determine the possible role of temperament in mental disorders in a national epidemiologic study. A nationally representative sample of adults (n=1320) was administered the Lebanese-Arabic version of the Temperament Evaluation of the Memphis, Pisa, Paris and San Diego Autoquestionnaire (TEMPS-A), and the Arabic CIDI 3.0, as part of the LEBANON study. The association among temperaments and DSM-IV mood, anxiety, and impulse control disorders was assessed. The anxious temperament was shown to be a robust predictor of most disorders, especially within the anxiety and depressive clusters. The hyperthymic temperament had a uniquely protective effect on most mental disorders, with the exception of separation anxiety, bipolar, substance abuse and impulse control disorders. These effects were moderated by age and education. Temperaments, previously largely neglected in epidemiologic studies, could play a major role in the origin of mental disorders.

The role of criterion A2 in the DSM-IV diagnosis of posttraumatic stress disorder.

BACKGROUND: Controversy exists about the utility of DSM-IV posttraumatic stress disorder (PTSD) criterion A2 (A2): that exposure to a potentially traumatic experience (PTE; PTSD criterion A1) is accompanied by intense fear, helplessness, or horror. METHODS: Lifetime DSM-IV PTSD was assessed with the Composite International Diagnostic Interview in community surveys of 52,826 respondents across 21 countries in the World Mental Health Surveys. RESULTS: Of 28,490 representative PTEs reported by respondents, 37.6% met criterion A2, a proportion higher than the proportions meeting other criteria (B-F; 5.4%-9.6%). Conditional prevalence of meeting all other criteria for a diagnosis of PTSD given a PTE was significantly higher in the presence (9.7%) than absence (.1%) of A2. However, as only 1.4% of respondents who met all other criteria failed A2, the estimated prevalence of PTSD increased only slightly (from 3.64% to 3.69%) when A2 was not required for diagnosis. Posttraumatic stress disorder with or without criterion A2 did not differ in persistence or predicted consequences (subsequent suicidal ideation or secondary disorders) depending on presence-absence of A2. Furthermore, as A2 was by far the most commonly reported symptom of PTSD, initial assessment of A2 would be much less efficient than screening other criteria in quickly ruling out a large proportion of noncases. CONCLUSIONS: Removal of A2 from the DSM-IV criterion set would reduce the complexity of diagnosing PTSD, while not substantially increasing the number of people who qualify for diagnosis. Criterion A2 should consequently be reconceptualized as a risk factor for PTSD rather than as a diagnostic requirement.

A rapid situation assessment (RSA) study of alcohol and drug use in Lebanon.

BACKGROUND: Research on substance use and misuse in Lebanon is scarce and, when available, focuses on a specific substance or a limited segment of the population. The objective of this Rapid Situation Assessment (RAS) study was to survey the use of multiple substances in diverse segments of the Lebanese population. METHODS: A multi-method and multi-sample survey was conducted to collect quantitative and qualitative data from the academic sector (high school and university students), substance users in treatment or under arrest (prison, detention), and non-institutionalized "street" users. RESULTS: Age of first use of substances started as early as 9 years in the youth sample. Moreover, 12% of the high school students reported smoking one or more packs of cigarettes per day and 9% of the university students met criteria for DSM-IV alcohol abuse. Cannabis represented the most commonly used illicit drug in both high school and university students, and tranquilizers were the most frequently misused medicinal substance. Heroin was responsible for 50% of the treatment admissions, followed by cocaine (20%), and alcohol (20%); heroin was also the most common substance of arrest. Recidivism was almost the rule for heroin users across all treatment settings. Unperceived need for treatment was the most common reason for not seeking treatment in non-institutionalized drug users (47.6%). Injecting drug use was a common behavior noted within substance using populations, in treatment and non-institutionalized (about 50% of them), with a high rate of needle sharing practices. About half of all patients in treatment had a history of police arrests, and about one-third of those in prison ever received prior treatment for substance use. CONCLUSION: The study points towards a growing trend for substance use problems in early adolescence that warrants close monitoring. Further investigation of these patterns is needed since the Lebanese population might have specific pathways of abuse. There is a need to bring together various health, legislative, and academic stakeholders for a continuous appraisal of data from substance abuse studies as evidenced by the recent, although slow, progress in the fields of legislation and treatment that follow such concerted efforts.

Dissemination of an evidence-based intervention to parents of children with behavioral problems in a developing country.

This project describes the dissemination of an evidence-based parenting skills intervention by training social and health workers with little or no mental health background so that they themselves train mothers of children with behavioral problems in impoverished communities in a developing country. The Strengths and Difficulties Questionnaire was completed by mothers to screen for children with behavioral problems and was repeated at the end of the intervention. Pre- and post-tests of knowledge and parenting attitudes were administered to mothers. Mental health workers trained social and health workers in social development centers and dispensaries. Each social and health worker trained mothers of children with behavioral problems under supervision utilizing an Arabic adaptation of the treatment manual for externalizing disorders "Helping Challenging Children" developed by the Integrated Services Taskforce of the World Psychiatric Association Child Mental Health Presidential Programme. A total of 20 workers and 87 mothers participated in the training. The proportion of children who obtained an SDQ total difficulties score in the abnormal range decreased from 54.4 to 19.7% after the training. Whereas 40.2% of mothers used severe corporal punishment with their children before the intervention, this decreased to 6.1% post-intervention. Three-fourths of mothers related that the program helped them develop new parenting skills. This pilot project demonstrated the feasibility of dissemination of a manual-based intervention and training of workers who have little background in mental health to offer effective services to families in impoverished communities who otherwise would have not received them. Successful replication in other developing countries would pave the way to incorporating such programs in national policies given their potential sustainability and cost-effectiveness.

ADHD in the Arab world: a review of epidemiologic studies.

OBJECTIVE: Epidemiological studies on psychiatric disorders are quite rare in the Arab World. This article reviews epidemiological studies on ADHD in all the Arab countries. METHOD: All epidemiological studies on ADHD conducted from 1966 through th present were reviewed. Samples were drawn from the general community, primary care clinical settings, and populations of traumatized children. Data on prevalence, gender differences, risk factors, comorbidity, and burden of ADHD were reviewed. RESULTS: ADHD rates in Arab populations were similar to those in other cultures. Comparisons within Arab studies were difficult given the variability of methodology and instruments used. CONCLUSION: There is an important need for research on ADHD in the Arab World, not only to assess the national prevalence in children and adolescents, but also to look at the differential burden and treatment of this disorder, which has high levels of mental comorbidities and high impact across the life span.

Risk estimates for hip fracture from clinical and densitometric variables and impact of database selection in Lebanese subjects.

Bone mineral density (BMD) and fracture incidence vary greatly worldwide. The data, if any, on clinical and densitometric characteristics of patients with hip fractures from the Middle East are scarce. The objective of the study was to define risk estimates from clinical and densitometric variables and the impact of database selection on such estimates. Clinical and densitometric information were obtained in 60 hip fracture patients and 90 controls. Hip fracture subjects were 74 yr (9.4) old, were significantly taller, lighter, and more likely to be taking anxiolytics and sleeping pills than controls. National Health and Nutrition Examination Survey (NHANES) database selection resulted in a higher sensitivity and almost equal specificity in identifying patients with a hip fracture compared with the Lebanese database. The odds ratio (OR) and its confidence interval (CI) for hip fracture per standard deviation (SD) decrease in total hip BMD was 2.1 (1.45-3.05) with the NHANES database, and 2.11 (1.36-2.37) when adjusted for age and body mass index (BMI). Risk estimates were higher in male compared with female subjects. In Lebanese subjects, BMD- and BMI-derived hip fracture risk estimates are comparable to western standards. The study validates the universal use of the NHANES database, and the applicability of BMD- and BMI-derived risk fracture estimates in the World Health Organization (WHO) global fracture risk model, to the Lebanese.

The epidemiology of anxiety disorders in the Arab world: a review.

Epidemiological studies are quite rare in the Arab world. The Institute for Development Research Advocacy and Applied Care (IDRAAC) has conducted a systematic review of all epidemiologic research on anxiety disorders in the Arab world up to 2006. Specific keywords were used in the search for affective disorders, namely anxiety, generalized anxiety disorder, GAD, panic, separation anxiety disorder, SAD, overanxious disorder, OAD, phobia, fear, post-traumatic stress disorder, PTSD, obsessive compulsive disorder (OCD), obsessive compulsive symptom (OCS), obsession, compulsion, obsessive, compulsive. All results were screened and categorized. Epidemiological data on prevalence, gender differences, age of onset, comorbidity, risk factors and treatment of anxiety disorders in the Arab world were found in clinical and community samples. There is an evident need for national data on anxiety disorders in the Arab world in order to identify the magnitude of these diseases and their burden on the individual and community.

Bereavement related and non-bereavement related depressions: a comparative field study.

BACKGROUND AND METHOD: In the otherwise a-theoretical diagnostic manual, the DSM-III and IV bereavement exclusion for the diagnosis of major depression (MDD) stands out as the sole exception to the rule. No other life event excludes the diagnosis of any other axis I disorder. Since this diagnostic convention has important diagnostic and treatment implications, it is important to evaluate the validity of this exception. By comparing multiple features of bereavement related to non-bereavement related MDD, this prospective community study critically evaluates the validity of the bereavement exclusion. RESULTS: The prevalence of conditional criteria was common in the total sample (N=685) and did not differ between bereaved and non-bereaved groups. The global 'symptom profile' of depressed individuals was similar in both groups. 'Duration' was found to be longer in the bereaved group. Among all conditional criteria required by DSM-IV to accept bereavement-related episodes under the category of MDD, only 'marked dysfunction' predicted treatment. Neither the 'four conditional symptoms' nor the 'duration' criterion predicted marked dysfunction. The 'risk for recurrence' was similar whether the first episode was bereavement related or not. LIMITATIONS: 'Psychotic symptoms' were not assessed, and 'marked dysfunction' was not assessed on a continuous scale. The number of DSM-IV excluded episodes was too small to allow for generalization. CONCLUSION: Our results suggest that the conditional criteria do not seem to serve the purpose of the originators of the bereavement exclusion criteria. The 'conditional symptoms' and the 'duration' criterion seem not to be markers of severity. We propose that the descriptive and etiologically neutral approach the DSM presumes in reaching a diagnosis should be applied in the case of MDD until more convincing data point to the contrary.

Alcohol use among college students: an international perspective.

PURPOSE OF REVIEW: The present review of published articles during 2005-2006 on alcohol use among college students in Africa, Asia, Australasia, Europe and South America assesses the prevalence of alcohol use, hazardous drinking and related problems, and reviews the effectiveness of intervention methods and implications for future research. RECENT FINDINGS: Research on alcohol use and related problems in college students is lacking in many regions of the world. We identified 26 papers in peer-reviewed journals, from Australia, Brazil, Ecuador, Egypt, Germany, Hong Kong, Ireland, Lebanon, New Zealand, Nigeria, Sweden, The Netherlands and Turkey. SUMMARY: More comprehensive studies with systematic methodologies in the world regions reviewed here are needed to yield representative results on alcohol use and related risk and protective factors in college settings. College students in many countries are at elevated risk for heavy drinking, with serious immediate health risks, such as drink-driving and other substance use; and longer term risks, such as alcohol dependence. The prevalence of hazardous drinking in Australasia, Europe and South America appears similar to that in North America, but is lower in Africa and Asia. Alcohol policies should be reviewed and prevention programmes initiated in light of research evidence, for this high-risk population.

Vertebral fracture risk and impact of database selection on identifying elderly Lebanese with osteoporosis.

The International Osteoporosis Foundation recommends using a universal database i.e. the NHANES database for the diagnosis of osteoporosis. Population-based databases for T-score calculation are still debated in terms of clinical and public health relevance. The current study aimed at estimating the prevalence of vertebral fractures in the Lebanese elderly, determining BMD-fracture relationship, and assessing the effect of database selection on osteoporosis prevalence and fracture risk assessment. Apparently healthy subjects were randomly selected from the Greater Beirut area - one-third of the Lebanese population at large - using a multilevel cluster technique. Subjects with medical conditions likely to affect bone metabolism i.e. history of major chronic disease, intake of medications that affect bone metabolism were excluded. Presence of vertebral fracture was estimated by a semi-quantitative assessment. Bone density was measured by central DXA. Clinical risk factors included age, gender, height, weight, body mass index, smoking, exercise, falls, previous fragility fracture and family history of fragility fracture. Impact of database selection was assessed by: (1) Comparison of sensitivity and specificity for prevalent vertebral fractures of the T-score

Suitability of the TEMPS-A for population-based studies: ease of administration and stability of affective temperaments in its Lebanese version.

BACKGROUND: The Temperament Evaluation of Memphis Pisa Paris and San Diego Auto-questionnaire (TEMPS-A) has been translated and validated into several languages, and used in different subgroups (e.g. clinical, students, company, employees and those with different educational levels). METHODS: Lebanon is the only country that has validated the TEMPS-A in a national cohort, as part of the Lebanese Evaluation of the Burden of Ailments and Needs Of the Nation (LEBANON). In this paper, we test the suitability of the TEMPS-A for large scale epidemiologic population-based studies. RESULTS: 82.1% of the respondents found the TEMPS-A to be easy to understand. The global reports of the Lebanese of their own temperaments paralleled those of the formal sub-scores on the five affective temperament subscales. The majority of respondents (90.3%) felt that their answers on the Lebanese-Arabic TEMPS-A scale represented them throughout their adulthood; the minority who did not were more likely to be older, and to have scored higher on the cyclothymic, and lower on the hyperthymic subscales. LIMITATION: Although the TEMPS-A has been designed for self-administration (auto-questionnaire), this was not practical in all subjects. We nonetheless feel that the interview format is viable as it introduces flexibility with certain subjects in population studies. CONCLUSIONS: The TEMPS-A appears to be suitable for use in epidemiologic surveys and research.

Hypovitaminosis D osteopathy: is it mediated through PTH, lean mass, or is it a direct effect?

Hypovitaminosis D is increasing worldwide and is associated with low bone mass. The effects of hypovitaminosis D on bone might be direct or mediated through decreased muscle mass and function and/or secondary hyperparathyroidism. This study systematically investigated the relative contribution of lean mass, PTH, and the direct effect of vitamin D as predictors of vitamin D mediated osteopathy in elderly individuals. 460 ambulatory subjects aged 65-85 years had their bone mass and lean body mass measured by a dual-energy X-ray absorptiometry. Serum calcium, phosphorus and alkaline phosphatase, intact parathyroid hormone (PTH) and 25-hydroxyvitamin D (25 OHD) were also measured. Serum 25 OHD correlated with lean body mass in men, r = 0.24, P = 0.002, but not in women; and with bone mass at all skeletal sites in men, r = 0.20-0.30, P < 0.02. Correlations were also noted at all skeletal sites in women except for the spine, r = 0.13-0.18, P < 0.04. In both genders, BMD at sites enriched in cortical bone was 0.4-0.7 SD lower in the group with the lowest vitamin D tertile than that in the group in the highest tertile. After controlling for PTH, the magnitude of the correlations between BMD and 25 OHD remained significant in both genders. After controlling for lean body mass, the magnitude of these correlations did not change in women and decreased but remained significant in men. After adjustment for age and height, both lean body mass and PTH had significant independent contributions to BMD variance at all skeletal sites. After adjustment for age, height, lean mass, and PTH, 25 OHD did not have any significant residual contribution to BMD variance except at the trochanter in men. This study demonstrates that vitamin D osteopathy in the elderly is in large part mediated through lean mass in men and through PTH levels in both genders, with a greater contribution of PTH in women than in men. There was little demonstrable independent relation between serum 25 OHD and bone mass.

Effect of vitamin D replacement on musculoskeletal parameters in school children: a randomized controlled trial.

BACKGROUND: Despite the high prevalence of hypovitaminosis D in children and adolescents worldwide, the impact of vitamin D deficiency on skeletal health is unclear. METHODS: One hundred seventy-nine girls, ages 10-17 yr, were randomly assigned to receive weekly oral vitamin D doses of 1,400 IU (equivalent to 200 IU/d) or 14,000 IU (equivalent to 2,000 IU/d) in a double-blind, placebo-controlled, 1-yr protocol. Areal bone mineral density (BMD) and bone mineral content (BMC) at the lumbar spine, hip, forearm, total body, and body composition were measured at baseline and 1 yr. Serum calcium, phosphorus, alkaline phosphatase, and vitamin D metabolites were measured during the study. RESULTS: In the overall group of girls, lean mass increased significantly in both treatment groups (P < or = 0.05); bone area and total hip BMC increased in the high-dose group (P < 0.02). In premenarcheal girls, lean mass increased significantly in both treatment groups, and there were consistent trends for increments in BMD and/or BMC at several skeletal sites, reaching significance at lumbar spine BMD in the low-dose group and at the trochanter BMC in both treatment groups. There was no significant change in lean mass, BMD, or BMC in postmenarcheal girls. CONCLUSIONS: Vitamin D replacement had a positive impact on musculoskeletal parameters in girls, especially during the premenarcheal period.

Densitometer type and impact on risk assessment for osteoporosis.

Studies have shown a high correlation between measurements of bone mineral density (BMD) obtained on differentdual-energy X-ray absorptiometry machines. Challenger osteodensitometers (Diagnostic Medical System [DMS],Montpellier, France) are becoming widely used but little is known about their clinical performance. The aim of this study was to compare BMD measurements and the resulting patient classification based on T-scores obtained on a DMS Challenger device to those obtained on Hologic 4500A (Bedford, MA) device. Fifty-three volunteers were studied. The BMD of the spine and of the hip were simultaneously measured on both densitometers. BMD values obtained on the Challenger were significantly higher than those obtained with the Hologic QDR4500 (p<0.001). The correlations coefficients between the Hologic QDR4500 and the DMS Challenger measured BMDs were r=0.70 at the femoral neck, r=0.70 at the trochanter, and r=0.83 at the spine (p<0.001). Among the 35 postmenopausal women, there was discordance in the WHO T-score-based classification in 28 subjects (80%) at the spine, 18 subjects (52%) at the femoral neck, and 14 subjects (42%) at the trochanter. The intermachine agreement was low: The kappa score was -0.10 at the spine, 0.2 at the femoral neck, and 0.3 at the trochanter. In conclusion, this study cautions against the use of non established densitometers that leads to underdiagnosis of patients and, subsequently, to inappropriate treatment strategies.

Psychometric properties of the Lebanese-Arabic TEMPS-A: a national epidemiologic study.

BACKGROUND: Several measures have been proposed to evaluate temperament traits and their connection to psychopathology. One recent development in this area is the TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire). The purpose of this study is to psychometrically validate the Lebanese-Arabic version of TEMPS-A. METHODS: The TEMPS-A was adapted to Lebanese-Arabic and administered to 1320 Lebanese (593 males, 727 females, mean age of 43+/-16 years) representing the adult population of Lebanon (total population: 4.2 million). This section was added by the Institute for Development Research and Applied Care (IDRAC) to the cross-national World Mental Health (WMH) initiative Lebanese chapter. Chronbach-alpha and Pearson's correlation were used to test the internal consistency and correlation among the subscales. Factor loadings were calculated using the principal component analysis with varimax rotation. RESULTS: Internal consistency varied between 0.66 (depressive) and 0.88 (anxious). As formulated by the originators of the instrument, five main factors emerged from the factor analysis, with some overlap between the depressive, the cyclothymic and the anxious temperaments, but almost none for the hyperthymic and irritable temperaments. The strongest correlation was observed between the anxious and the cyclothymic temperament subscales. Women had higher mean scores on the depressive, cyclothymic, and anxious subscales, whereas men scored higher on the hyperthymic subscale. There was a trend of increase by age in scores of the depressive subscale, and a trend of decrease in the cyclothymic and irritable subscales. CONCLUSION: The Lebanese-Arabic TEMPS-A has a good internal consistency, is easy to use, and opens new and interesting research avenues in large epidemiologic national studies on temperament.

Pamidronate in the prevention of chemotherapy-induced bone loss in premenopausal women with breast cancer: a randomized controlled trial.

PURPOSE: Mortality from breast cancer has decreased in large part because of adjuvant chemotherapy. Sequelae of therapy include ovarian failure and bone loss, loss that would increase these patients' risk of fracture with aging. In this study, we assessed the efficacy of pamidronate in preventing such loss. PATIENTS AND METHODS: The study was a 1-yr randomized, double-blind, placebo-controlled trial comparing pamidronate 60 mg iv every 3 months with placebo in 40 premenopausal women with newly diagnosed breast cancer. Bone mineral density (BMD) of the spine and hip and remodeling markers were monitored over 1 yr. RESULTS: Over half of the subjects became amenorrheic, and those who did were 4 yr older than those who did not (P = 0.02). The mean difference in percent change in BMD at 12 months between the two treatment groups was 5.1% at the lumbar spine (P = 0.002) in the overall study group and 5% at the lumbar spine and 5.2% at the total hip in the amenorrheic subgroup (P < 0.03). Biochemical markers of bone remodeling did not differ between the two treatment groups, and treatment was well tolerated. CONCLUSION: Chemotherapy-induced amenorrhea is common with ensuing bone loss at the spine and hip. Pamidronate prevented bone loss at the spine and hip and was well tolerated.