Inflammatory bowel disease among patients with psoriasis treated with ixekizumab: A presentation of adjudicated data from an integrated database of 7 randomized controlled and uncontrolled trials.

BACKGROUND: Inflammatory bowel disease (IBD) occurs more frequently in patients with psoriasis. The 2 diseases have significant genetic overlap, but the pathogenesis underlying their co-occurrence is unknown. OBJECTIVE: We sought to report adjudicated IBD cases (Crohn's disease [CD] and ulcerative colitis [UC]) in patients exposed to ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A. METHODS: Adverse events (AEs) integrated from 7 randomized controlled and uncontrolled trials were analyzed for the controlled induction period, controlled maintenance period, and all ixekizumab-treated patients. Suspected IBD cases were reviewed by blinded external experts using internationally recognized criteria (Registre Epidemiologique des Maladies de l'Appareil Digestif registry). RESULTS: In all, 4209 patients (6480 patient-exposure years) were exposed to ixekizumab. Suspected CD (N = 12) or UC (N = 17) AEs were reported; 19 were adjudicated as definite/probable IBD (CD, N = 7, incidence rate = 1.1/1000 patient-exposure years; UC, N = 12, incidence rate = 1.9/1000 patient-exposure years). Among these, 3 occurred during induction (CD, N = 1; UC, N = 2) and 7 during maintenance (CD, N = 4; UC, N = 3). Twelve of 16 patients with reported IBD history have not had an IBD treatment-emergent AE/serious AE to date. LIMITATIONS: Clinical review (adjudication) was not prespecified. AE data collected post-hoc may have been limited by length of time from occurrence. CONCLUSION: From an integrated database of 7 ixekizumab psoriasis trials, CD and UC cases were uncommon (<1%).

Durability of glycemic control with insulin lispro mix 75/25 versus insulin glargine for older patients with type 2 diabetes.

BACKGROUND AND AIMS: Few studies have evaluated long-term durability of glycemic control in older patients. The aim of this study was to compare durability of glycemic control of twice-daily insulin lispro mix 75/25 (LM75/25; 75 % insulin lispro protamine suspension, 25 % insulin lispro) and once-daily insulin glargine (GL) added to oral antihyperglycemic medications in older patients (≥65 years of age). METHODS: Patients were participants in the maintenance phase of the DURABLE trial. During the initiation phase, patients with type 2 diabetes were randomized to LM75/25 or GL. After 6 months, patients with hemoglobin A1c (HbA1c) ≤7.0 % advanced to the 24-month maintenance phase. The primary objective was between-group comparison of duration of maintaining the HbA1c goal in older patients (≥65 years of age). A similar analysis was conducted for older patients achieving HbA1c ≤6.5 % in the initiation phase. RESULTS: Median time of maintaining HbA1c goal was longer in LM75/25 versus GL (19.6 versus 15.4 months, p = 0.007) and more LM75/25 patients maintained goal versus GL (49.2 versus 30.4 %; p = 0.003). HbA1c reduction from baseline was greater in LM75/25 versus GL (-1.56 ± 0.10 versus -1.24 ± 0.11 %; p = 0.003). Post-meal glucose was significantly lower in LM75/25 versus GL (158.86 ± 3.42 versus 171.67 ± 4.51 mg/dL; p = 0.017). No differences were observed in overall and severe hypoglycemia. LM75/25 patients had higher daily insulin doses (0.41 ± 0.02 versus 0.32 ± 0.02 units/kg/day; p < 0.001) and more weight gain (5.47 ± 0.49 versus 3.10 ± 0.53 kg; p = 0.001). Similar results were generally obtained in older patients with HbA1c ≤6.5 %. CONCLUSIONS: In our evaluation of older patients from a larger trial, LM75/25 appeared to provide longer durability of glycemic control, as well as a greater number of patients maintaining HbA1c goal versus GL.

Impact of race/ethnicity on efficacy and safety of two starter insulin regimens in patients with type 2 diabetes: a posthoc analysis of the DURABLE trial.

OBJECTIVE: To explore the impact of race/ethnicity on efficacy and safety of twice-daily insulin lispro mix 75/25 (LM75/25; 75% lispro protamine suspension, 25% insulin lispro) and once daily insulin glargine (GL). DESIGN, SETTING, PATIENTS: More than 2,000 Patients with type 2 diabetes enrolled in the 24-week initiation phase of the DURABLE Trial. MAIN OUTCOME MEASURES: Efficacy and safety variables at endpoint, including hemoglobin A1c (HbA1c), self-monitored plasma glucose (SMPG), and hypoglycemia, in each racial/ethnic group were compared to Caucasians within treatment groups. RESULTS: Asian patients had less (LM75/25: -1.46%, P < .01; GL: -1.25%, P < .01) and Hispanic patients had greater (LM75/25: -2.17%) HbA1c reduction from baseline vs Caucasian patients (LM75/25: -1.84%; GL: -1.78%). Fewer Asian (LM75/25: 20%, P < .001; GL: 22%, P < .001) and Hispanic patients (LM75/25: 40%, P < .01) reached HbA1c target (< 7%) vs Caucasian patients (LM75/25: 53%; GL: 44%). Fasting plasma glucose was similar among groups, postprandial glucose (PPG) with GL was lower for African patients post-breakfast and post-dinner and higher for Asian patients post-lunch. Only PPG with LM75/25 was lower for Hispanic patients post-breakfast. Weight gain was lower in Asian patients (LM75/ 25). Insulin dose was higher for Asian (LM75/25 and GL) and lower for African patients (GL). Hypoglycemia rate was lower for Asian (LM75/25 and GL) and Hispanic patients (LM75/25). CONCLUSIONS: There were significant efficacy and safety differences among racial/ethnic groups in the DURABLE trial. These differences may be important in designing insulin based treatment plans.

Health literacy and willingness to use online health information by teens with asthma and diabetes.

OBJECTIVE: This study measured health literacy in a population of teens in treatment for asthma or diabetes and tested the association between health literacy and willingness to use online health resources. MATERIALS AND METHODS: About 180 patients aged 13-18 years treated for asthma or diabetes in specialty care clinics completed assessments of demographic characteristics, health literacy, and Internet access and use. Teens were provided a resource page listing selected publically available health-related Web sites and asked about perceived ease of use, perceived usefulness, and intent to use the listed Web sites. The relationship between demographic characteristics, health literacy, and online health information use was tested using chi-squared or Fisher's exact test. Predictors of intent to use resource page Web sites were assessed using bivariate and multivariate ordinal logistic regression. RESULTS: About 92% of participants had adequate health literacy. Over 50% of participants had previously searched online for health information. Older age was the only significant predictor of health information search. Most teens (79%) reported intent to use at least one Web site from the resource page at least occasionally within the next 3 months. Higher health literacy (odds ratio [OR]=6.24, p<0.01) and stronger perceived usefulness (OR=1.74, p=0.01) were associated with greater intent for regular use, after controlling for demographic and Internet access variables. CONCLUSIONS: Teens with lower health literacy searched online for health information as often as peers with higher literacy, but were less likely to express the intent to use recommended sites. Belief in the usefulness of a Web site is the strongest attitudinal predictor of intended future use.

Obesity and dyslipidemia in behaviorally HIV-infected young women: Adolescent Trials Network study 021.

BACKGROUND: The goal of this study was to determine the nature and prevalence of abnormalities in lipids, glucose metabolism, and body composition in behaviorally human immunodeficiency virus (HIV)-infected young women and the relationship of these abnormalities to different classes of antiretroviral therapy regimens. METHODS: We conducted a cross-sectional, multicenter study involving 173 behaviorally HIV-infected women aged 14-24 years and 61 HIV-seronegative control subjects. HIV-infected women were categorized as follows: antiretroviral therapy naive (n=85), receiving a regimen containing a nonnucleoside reverse-transcriptase inhibitor (NNRTI; n=33), receiving a regimen containing a protease inhibitor (PI; n=36), or receiving a regimen not containing an NNRTI or a PI (n=19). Measurements included fasting lipid levels, glucose and insulin levels before and 2 hours after an oral glucose challenge, high-sensitivity C-reactive protein (hsCRP) levels, anthropometry, fat distribution (measured by dual energy X-ray absorptiometry), and antiretroviral therapy and medical histories. Race-adjusted results were compared across groups and within HIV-infected groups. RESULTS: The median age of participants was 20 years. Of HIV-infected subjects, 77% were African American, 35% smoked cigarettes, and 32% reported exercising regularly. More than 40% had a body mass index > or =25. Triglycerides; total, high-density lipoprotein (HDL), and non-HDL cholesterol; and hsCRP levels differed significantly among groups, with higher levels being most common among those receiving antiretroviral therapy. Indices of glucose metabolism did not differ among groups. In general, cholesterol levels, hsCRP levels, and indices of glucose metabolism worsened as body mass index increased. CONCLUSIONS: Obesity, dyslipidemia, and inflammation were prominent among HIV-infected adolescent women and, coupled with other risk factors, may accelerate the lifetime risk of cardiovascular disease and other adverse events. These results underscore the need for a multifaceted approach to addressing risk reduction in this population.

Insulin-like growth factor-I levels predict weight, height and protein catabolism in children and adolescents with cystic fibrosis.

Multiple reports have demonstrated the benefit of growth hormone (GH) treatment in children with cystic fibrosis (CF) and previous studies have demonstrated low to normal insulin-like growth factor-I (IGF-I) levels in these patients. Most biological effects of GH are mediated by IGF-I; however, the relationship between height, weight and rate of growth has not been systematically studied in CF. We conducted a retrospective analysis of 52 patients (including control volunteers with CF) who had participated in previous studies of GH treatment to determine the relationship between levels of IGF-I and growth in children with CF. In a subset of these patients, we also evaluated the relationship between protein catabolism and IGF-I. Baseline IGF-I levels and IGF-I z-scores were correlated with same day measures of height, weight, height and weight z-scores. In a subset of patients, IGF-I levels were also correlated with leucine rate of appearance (a measure of protein catabolism). IGF-I levels were obtained every six months during our studies and were correlated with same day height, weight and protein turnover. Height and weight velocity were calculated every six months from study baseline and were correlated with IGF-I levels. In all patients, whether treated with GH or controls, we found a positive linear correlation between IGF-I levels and height (r = 0.66, p < 0.0001) and weight (r = 0.61, p < 0.0001), as well as height and weight velocity. There was also a strong relationship between leucine rate of appearance and IGF-I. These results suggest a strong correlation between IGF-I and height, weight and protein catabolism and emphasize the need to normalize IGF-I levels in children with cystic fibrosis.

Improvement in insulin sensitivity and dyslipidemia in protease inhibitor-treated adult male patients after switch to atazanavir/ritonavir.

BACKGROUND: Treatment of human immunodeficiency virus (HIV) with protease inhibitors (PIs) is associated with insulin resistance, triglyceride-rich dyslipidemia, and fat redistribution. Atazanavir (ATV), a potent once-daily PI, has been recognized for its convenience to patients, and some studies describe improved lipid metabolism. However, its effects on insulin sensitivity have not been elucidated. We conducted this study to test the hypothesis that ATV improves insulin resistance and dyslipidemia. METHODS: We prospectively studied 9 HIV-infected men with dyslipidemia (median age, 53 years; baseline triglyceride level, >200 mg/dL) on stable PI-containing antiretroviral therapy who elected to change PI therapy to ritonavir-boosted ATV therapy, dose of 300/100 mg. We measured insulin resistance at baseline and after 12 weeks of therapy using a hyperinsulinemic euglycemic clamp (insulin dose, 200 mU/m minute). Fasting lipid profiles and body composition (whole-body dual energy x-ray absorptiometry) were also measured at baseline and after 12 weeks. RESULTS: All 9 patients completed the study and maintained undetectable viral loads (<50 copies/mL) and stable CD4 counts. After 12 weeks, insulin sensitivity significantly improved (+28%; P = 0.008) in all patients. Triglyceride levels also improved. CONCLUSIONS: Using the gold-standard euglycemic clamp, ritonavir-boosted ATV therapy improved PI-induced insulin resistance among dyslipidemic HIV-infected men on PI-based antiretroviral therapy. These findings were not attributable to a change in body weight and provide further evidence for ATV's unique metabolic profile among the PIs.

Elevated gluconeogenesis and lack of suppression by insulin contribute to cystic fibrosis-related diabetes.

The incidence of diabetes is high in cystic fibrosis (CF) and is an important cause of morbidity and mortality. Understanding the pathophysiology is imperative. Studies have documented increased endogenous (mostly hepatic) glucose production (HGP) but have not distinguished the relative contribution of gluconeogenesis (GNG). The purpose of this study was to quantitate GNG, to determine its contribution to high HGP, and to measure insulin's suppression of GNG. We recruited 31 adult CF subjects (age, 26.2+/-7.9 years; 12 female subjects) and quantified GNG by measuring the incorporation of H into the second and fifth carbons of glucose. Hepatic glucose production was measured using [6,6-H2]glucose. Protein breakdown was measured using [1-C]leucine. Data were compared with that from 11 healthy volunteers (age, 27.5+/-7.0 years) who underwent both GNG and clamp studies. Thirteen CF subjects and all controls had a hyperinsulinemic euglycemic clamp during measures of GNG. Other measures included glucose tolerance and glucagon and cortisol levels. Rate of GNG was higher in CF subjects than controls and comprised a greater percentage of fasting HGP (GNG as percent of HGP: CF=68%; controls=44%; P=0.034). Suppression of GNG by insulin was significantly lower in CF than in controls and was lower in CF subjects with abnormal glucose tolerance than in those with normal glucose tolerance. Gluconeogenesis correlated with protein breakdown. These studies suggest that high HGP in CF is mostly from elevated rates of GNG and that resistance to insulin's suppression of GNG may contribute to abnormal glucose tolerance in CF.

Insulin resistance in Hispanic large-for-gestational-age neonates at birth.

CONTENT: Intrauterine exposure to maternal diabetes and large size at birth are known risk factors for the subsequent development of insulin resistance and metabolic syndrome. Although Hispanic youth have been shown to have a high prevalence of metabolic syndrome, it is unknown whether metabolic abnormalities and a predisposition for glucose intolerance are present at birth. OBJECTIVE: The objective of the study was to determine whether abnormalities in insulin sensitivity exist at or soon after birth in large-for-gestational-age neonates born to Hispanic women with and without gestational diabetes. DESIGN/PATIENTS/SETTING: Forty-two term Hispanic neonates were enrolled for cross-sectional studies at 24-48 h after birth and included nine large-for-gestational-age neonates delivered of women with gestational diabetes (large-for-gestational-age-IDM), 12 large-for-gestational-age but not IDM neonates, 11 poorly grown (at the fifth to 10th percentile), and 10 appropriate-for-gestational-age neonates. Insulin sensitivity and secretion were measured by shortened fasting iv glucose tolerance test. MAIN OUTCOME MEASURE: Insulin sensitivity index was measured within 48 h of birth. RESULTS: Neonates were studied at 36 +/- 11 h postnatally, and all groups were euglycemic at the time of study. However, insulin sensitivity was significantly lower (P < 0.05, ANOVA) in large-for-gestational-age-IDM [3.0 +/- 0.7 (sem) mU/liter.min] and large-for-gestational-age-non-IDM (2.2 +/- 0.4 mU/liter.min) cohorts in comparison with poorly grown (5.0 +/- 0.7 mU/liter.min) and appropriate-for-gestational-age controls (5.4 +/- 0.8 mU/liter.min). Insulin secretion did not differ between groups. CONCLUSIONS: Reduced insulin sensitivity is present soon after birth in Hispanic large-for-gestational-age neonates born to mothers with and without gestational diabetes, demonstrating the onset of insulin resistance before birth and evidence of altered fetal programming.

A review of the management of two common clinical problems found in patients with cystic fibrosis: cystic fibrosis-related diabetes and poor growth.

BACKGROUND: Cystic fibrosis-related diabetes (CFRD) and glucose intolerance often occur in teens and adults with CF. The initial deficiency is an impaired first-phase insulin response; as patients age, peak insulin response is delayed and less robust than normal. Decreased insulin sensitivity (insulin resistance) is also present in patients with CF. Insulin is the only currently recommended therapy for all types of CFRD, and many clinicians find that basal/bolus regimens are optimal. Another common finding in children with CF is poor linear growth and inadequate weight gain. Recombinant human growth hormone (rhGH) is being explored in this patient population; studies overall show improvements in height and weight, without development of glucose intolerance. CONCLUSIONS: rhGH may be a useful growth-promoting therapy in children with CF.

Twenty years of recombinant human growth hormone in children: relevance to pediatric care providers.

Recombinant human growth hormone has revolutionized the management of children and adolescents with growth hormone deficiency and other growth disorders, but clinical and ethical controversies remain regarding diagnostic approach, optimal recombinant human growth hormone dose and duration, and expected outcomes. Management of pubertal and transitioning patients with growth hormone deficiency has also commanded increased attention. Recent clinical studies that demonstrate the positive health benefits of recombinant human growth hormone in children with cystic fibrosis, inflammatory bowel disease, and juvenile rheumatoid arthritis have not yet clarified issues about patient selection and appropriate long-term use. An understanding of current recombinant human growth hormone indications and controversies can facilitate patient evaluation and expedite referral for potential treatment. This review summarizes current indications for recombinant human growth hormone use, discusses clinical challenges, and provides recommendations for pediatricians caring for children who may be appropriate candidates for recombinant human growth hormone therapy.

Analyzing breath samples of hypoglycemic events in type 1 diabetes patients: towards developing an alternative to diabetes alert dogs.

Diabetes is a disease that involves dysregulation of metabolic processes. Patients with type 1 diabetes (T1D) require insulin injections and measured food intake to maintain clinical stability, manually tracking their results by measuring blood glucose levels. Low blood glucose levels, hypoglycemia, can be extremely dangerous and can result in seizures, coma, or even death. Canines trained as diabetes alert dogs (DADs) have demonstrated the ability to detect hypoglycemia from breath, which led us to hypothesize that hypoglycemia, a metabolic dysregulation leading to low blood glucose levels, could be identified through analyzing volatile organic compounds (VOCs) contained within breath. We hoped to replicate the canines' detection ability and success by analytically using gas chromatography/mass spectrometry of VOCs in 128 breath samples collected from 52 youths with T1D at two different diabetes camps. We used different tests for significance including Ranksum, Student's T-test, and difference between means, and found a subset of 56 traces of potential metabolites. Principle component and linear discriminant analysis (LDA) confirmed a hypoglycemic signature likely resides within this group. Supervised machine learning combined with LDA narrowed the list of likely components to seven. The technique of leave one out cross validation demonstrated the model thus developed has a sensitivity of 91% (95% confidence interval (CI) [57.1, 94.7]) and a specificity of 84% (95% CI [73.0, 92.7]) at identifying hypoglycemia. Confidence intervals were obtained by bootstrapping. These results demonstrate that it is possible to differentiate breath samples obtained during hypoglycemic events from all other breath samples by analytical means and could lead to developing a simple analytical monitoring device as an alternative to using DADs.

Growth hormone treatment improves growth and clinical status in prepubertal children with cystic fibrosis: results of a multicenter randomized controlled trial.

CONTEXT: This multicenter, randomized, controlled, crossover trial of prepubertal children with cystic fibrosis (CF) tests the hypotheses that recombinant human GH (rhGH) treatment 1) improves height, weight, lean mass, and bone content irrespective of baseline measures; 2) improves clinical status and quality of life; and 3) has continued effect after cessation after 1 yr of treatment. METHODS: Sixty-one prepubertal subjects (

Screening for type 2 diabetes in children with acanthosis nigricans.

Acanthosis nigricans is a physical finding of the skin that appears to be a marker for insulin resistance. Because of the association of insulin resistance and type 2 diabetes, acanthosis nigricans may also be a marker for type 2 diabetes. Some states have recommended statewide screening for acanthosis nigricans. However, this has led to a large referral of children to pediatric endocrinologists. Presented is a schema for primary care physicians and school nurses to use as a guideline for referral of children with acanthosis nigricans.

Growth hormone normalizes pubertal onset in children with cystic fibrosis.

UNLABELLED: Children with cystic fibrosis (CF) have a high incidence of delayed puberty and poor growth. We retrospectively reviewed pubertal maturation data from 105 children with CF who had participated in studies on growth hormone (GH). As part of the GH study, participants were randomized into two cohorts, one of which was treated with GH for 1 year, and then followed off GH, and the other group was first followed off GH, and then treated with GH for 1 year. Pubertal staging was obtained throughout these studies and we have retrospectively analyzed the data. RESULTS: In prepubertal females, GH treatment resulted in a normalized onset of breast development as compared to delayed onset in non-treated females. Females treated during puberty had a normal tempo of breast development. In prepubertal males, GH treatment resulted in a normalized onset of testicular volume compared to non-treated males. Testicular size progression was not accelerated in pubertal boys treated with GH. CONCLUSION: GH treatment normalizes pubertal onset in prepubertal children with CF.

Guide to bone health and disease in cystic fibrosis.

Cystic fibrosis (CF) is the most common genetic disease within the Caucasian population and leads to premature respiratory failure. Approximately 60,000 individuals are currently living with CF in North America and Europe, 40% of whom are adults. The life span of these patients has increased from approximately 2 to 32 yr of age over the last three decades. Bone disease has emerged as a common complication in long-term survivors of CF. Some studies have observed that 50-75% of adults have low bone density and increased rates of fractures. Prevention and treatment of CF-related bone disease must address the myriad risk factors (decreased absorption of fat-soluble vitamins due to pancreatic insufficiency, altered sex hormone production, chronic lung infection with increased levels of bone-active cytokines, physical inactivity, and glucocorticoid therapy) for poor bone health. This review is a condensed and updated summary of the Guide to Bone Health and Disease in Cystic Fibrosis: A Consensus Conference, a statement that evolved from a meeting convened by the Cystic Fibrosis Foundation in May 2002 to address the pathogenesis, diagnosis, and treatment of bone disease in CF. The goal of this conference was to develop practice guidelines for optimizing bone health in patients with CF.

The metabolic effects of pregnancy in cystic fibrosis.

OBJECTIVE: Our purpose was to determine glucose tolerance in pregnant women with cystic fibrosis (CF) and to relate glucose tolerance to insulin sensitivity, hepatic glucose production, and protein turnover. METHODS: We studied 8 CF women during pregnancy (CFPreg). Results were compared with those from 9 pregnant controls (PregCont) and 8 nonpregnant CF women (CFCont). The following metabolic studies were conducted: oral glucose tolerance test (OGTT), hyperinsulinemic euglycemic clamp, stable isotope infusion of [1-13C]leucine and [6,6-2H2]glucose for measurement of whole body protein turnover and hepatic glucose production (HGP), respectively. Indirect calorimetry was used to measure resting energy expenditure (REE), and food intake was measured by 3-day food journals. Fat-free mass was measured by total body potassium 40K scan. RESULTS: All but one CFPreg developed diabetes by the end of the second trimester and had significantly lower insulin secretion and more insulin resistance than PregCont. Hepatic glucose production was significantly higher and suppression by insulin was less in CF subjects, and protein breakdown was significantly higher. Insulin resistance and HGP increased during pregnancy similarly in CFPreg and PregCont groups. CONCLUSION: Pregnancy in CF is associated with decreased insulin sensitivity and high HGP, in addition to inherent decreased insulin secretion. Pregnancy in CF is also associated with increased protein turnover and less response to insulin's anticatabolic effect. These changes appear to predispose the pregnant CF women to early development of diabetes and poor weight gain.

Growth hormone improves bone mineral content in children with cystic fibrosis.

AIM: Osteoporosis and osteopenia have been reported as common complications of cystic fibrosis (CF); however, little is known about accrual of bone mineral in CF. The goal of our study was to measure bone mineral content (BMC) in non-acutely-ill, but poorly growing children with CF, and to determine the relationship between height, lean body mass and BMC. Our second aim was to evaluate the effect of one year of treatment with human recombinant growth hormone (GH) on total body BMC. METHODS: We measured total-body BMC using dual energy X-ray absorptiometry in 32 poorly growing (height < or =10th percentile for age) prepubertal Caucasian children (ages 7 years 6 months-12 years 9 months, 17 M and 15, F) with CF. BMC and lean tissue mass (LTM) were measured at baseline, at 6 months and one year. One half of the children were randomly assigned to receive treatment with GH (GHTX). Results were compared to reference data maintained for healthy children matched for age and ethnicity. Sex steroid and IGF-I levels were also measured. RESULTS: Children with CF exhibited lower total body BMC and LTM than age-, ethnicity- and gender-matched controls. This was still apparent when the data were matched for height and bone age. BMC correlated with height, LTM, and IGF-I levels. Although at baseline the groups were similar, the GHTX group demonstrated significantly greater increase in height, weight, LTM and BMC than the NonTX group. These differences remained despite correction for increase in height CONCLUSION: Our study is the first to evaluate BMC in children with CF and suggests that poor accumulation of bone mineral is a problem. We have further demonstrated that GH treatment improves accumulation of bone mineral.