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Aim: To describe the clinical nurse specialist role and its outcomes and challenges., Design: Participatory Action Research conducted in Finland between the fall of 2017 and the end of 2018., Methods: A core participatory action research team (n = 10) led the design, implementation and evaluation of the research. Multiple data collection methods were used. The study is reported using the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines for participatory action research., Results: The clinical nurse specialist used most of the time in clinical patient care followed by clinical nursing leadership and scholarship activities. Outcomes of successful implementation led to increased visibility of nursing expertise, development, integration and quality assurance of nursing processes and practice, and promotion of knowledge translation and unit and collaborator cooperation. Furthermore, role challenges were also recognized., (© 2022 The Authors. Nursing Open published by John Wiley & Sons Ltd.)

Background: Data regarding patient education and smoking habits among bladder cancer patients are scarce., Objective: To investigate awareness of smoking as a risk factor for bladder cancer among bladder cancer patients., Design, Setting, and Participants: This is a substudy of a prospective, randomized, multicenter phase 3 trial (FinnBladder 9, NCT01675219). The data were collected at baseline and after 12 mo of follow-up between 2012 and 2020., Intervention: Patients completed a comprehensive nonvalidated questionnaire on smoking in relation to bladder cancer., Outcome Measurements and Statistical Analysis: The outcomes measured were patient-reported awareness of smoking as a risk factor for bladder cancer, and the effect of smoking on bladder cancer-related recurrence, progression, and death. Parametric data were compared using Student's t test and proportions using Fischer's exact test. Factors affecting baseline awareness of the effect of smoking cessation on bladder cancer were studied using logistic regression., Results and Limitations: Of the 411 patients randomized, 370 completed the baseline questionnaire and were included in the analysis. At baseline, 44% of patients were uncertain if smoking was a risk factor for bladder cancer. Patient awareness of the fact that smoking cessation reduces the risk of bladder cancer recurrence increased from 86% to 92% after 12 mo of follow-up (p = 0.038). Older patients and patients with recurrent bladder cancer had significantly less knowledge about the effect of smoking on bladder cancer recurrence, progression, and mortality. A major limitation is that the response rate was lower at the 12-mo follow-up visit than at baseline., Conclusions: Awareness of smoking as a bladder cancer risk factor is low. Older patients and patients with recurrent bladder cancer may need special attention regarding education., Patient Summary: We looked at outcomes for smoking-related patient education on bladder cancer in a Finnish population. We conclude that older patients and patients with recurrent bladder cancer may need to be educated on this subject., (Copyright © 2022 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Calcium plays a key role in skeletal mineralization and several intracellular and extracellular homeostatic networks. It is an essential element that is only available to the body through dietary sources. Daily acquisition of calcium depends, in addition to the actual intake, on the hormonally regulated state of calcium homeostasis through three main mechanisms: bone turnover, intestinal absorption, and renal reabsorption. These procedures are regulated by a group of interacting circulating hormones and their key receptors. This includes parathyroid hormone (PTH), PTH-related peptide, 1,25-dihydroxyvitamin D, calcitonin, fibroblast growth factor 23, the prevailing calcium concentration itself, the calcium-sensing receptor, as well as local processes in the bones, gut, and kidneys., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: Ectopic ACTH syndrome (EAS) is rare. We established a national cohort to increase awareness and address unmet needs., Methods: The Finnish national EAS cohort includes 60 patients diagnosed in 1997-2016. We assessed clinical features, diagnostic work-ups, treatments, incidence, and outcomes of subgroups occult tumor (OT), well-differentiated neuroendocrine tumor G1/G2 (NETG1/G2) and NET G3/neuroendocrine carcinoma (NETG3/NEC)., Results: The distribution of OT, NETG1/G2, and NETG3/NEC was 10 (17%), 20 (33%), and 30 (50%), respectively; and median follow-up 22 months (0-249). Annual incidence (0.20-0.93 per million inhabitants) and tumor subgroups (OT vs. NEC) varied across the country. The longest diagnostic delay from EAS onset to radiological tumor identification was 48 months. In NET/NEC, 6/50 (12%) were diagnosed 1-24 years before EAS onset. Osteoporotic fractures (32%) and severe infections (55%) were common. The CRH stimulation test accurately diagnosed EAS in 25/31 (81%). Metyrapone (≤6 g daily, prescribed in 88%) was well tolerated. In NETG1/G2, 13/20 (65%) underwent curative resection of the primary tumor; four experienced recurrence within 2-12 years. In OT, 70% underwent bilateral adrenalectomy. Five-year overall survival in OT, NETG1/G2, and NETG3/NEC was 90%, 55%, and 0%, respectively (P < 0.001). Morning cortisol, hypokalemia, infections, metastatic disease, and acute onset were negative, whereas resection of the primary tumor and bilateral adrenalectomy were positive predictors of survival., Conclusions: NET/NEC may precede EAS onset by several years. In NETG1/G2, recurrences may occur > 10 years after successful primary surgery. Tumor subgroup (OT, NETG1/G2, NEC) was an independent predictor of survival., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Aim: To develop, implement and evaluate the clinical nurse specialist's role within a specialist medical healthcare hospital. A secondary aim was to assess the feasibility of the 'Clinical Nurse Specialist Conceptualisation, Implementation, and Evaluation framework' in the role implementation., Background: Implementation of advanced practice nursing roles is an increasing practice around the globe; however, the implementation of these roles is multidimensional, complex process. Clear implementation strategies are needed., Design: Participatory action research was conducted in Finland between 2017-2018., Methods: The researchers adopted an outsider approach to work with staff, considered as co-researchers, within two participating units. A combination of several methods, such as focus group interviews, action-learning groups and researcher reflective field journal, was used to gather data. The 'Clinical Nurse Specialist Conceptualisation, Implementation, and Evaluation framework' was used to structure the processes undertaken, and the Donabedian structure, process and outcome model was used to structure and analyse the results. The study was reported using the EQUATOR guideline for participatory action research., Results: The results demonstrated the complexity of the role implementation process. Four implementation themes of need analysis, role design, role implementation and role evaluation were examined and described through their structures, processes and outcomes. The 'Clinical Nurse Specialist Conceptualisation, Implementation and Evaluation framework' was validated for its appropriateness guiding the role implementation process., Conclusions: Role implementation is a complex process which structured, practical guidelines may facilitate. The examined framework may facilitate the role implementation process conducted within organisations., Relevance to Clinical Practice: This research provides complimentary information for individuals and organisations aiming to develop a clinical nurse specialist or other advanced practice nursing roles. Furthermore, we describe a participatory action research process, which offers the means for self-reflection and planning of purposeful actions to improve the conditions of clinical practice., (© 2021 The Authors. Journal of Clinical Nursing published by John Wiley & Sons Ltd.)

Purpose: To investigate the symptoms and delays in the clinical pathway of bladder cancer (BC)., Methods: This is a substudy of a prospective, randomized, multicenter phase III study (FinnBladder 9, NCT01675219) where the efficacy of photodynamic diagnosis and 6 weekly optimized mitomycin C instillations are studied in pTa bladder cancer with high risk for recurrence. The data of presenting symptoms and critical time points were prospectively collected, and the effect of factors on delays was analyzed., Results: At the time of analysis, 245 patients were randomized. Analysis included 131 patients with primary bladder cancer and their complete data. Sixty-nine percent had smoking history and 67% presented with macroscopic hematuria. Median patient delay (from symptoms to health-care contact) was 7 days. The median general practice delay (from health-care contact to urology referral) was 8 days. Median time from urology referral to cystoscopy was 23 days and from cystoscopy to TUR-BT 21 days. Total time used in the clinical pathway (from symptom to TUR-BT) was 78 days. Current and former smokers had non-significantly shorter patient-related and general practice delays compared to never smokers. TUR-BT delay was significantly shorter in patients with malignant cytology (16 days) compared to patients with benign cytology (21 days, p = 0.03)., Conclusions: Patient-derived delay was short and most of the delay occurred in the referral centers. The majority had macroscopic hematuria as the initial symptom. Surprisingly, current and past smokers were more prone to contact the health-care system compared to never smokers.

Introduction: Nutritional deficiencies may occur after bariatric surgery despite supplementation. Fracture risk may also be elevated after bariatric surgery., Objectives: To compare 25-hydroxyvitamin D [25(OH)D], vitamin B12, and albumin serum concentrations in severely obese patients who had undergone either Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). Fracture data was compared with data for a conservatively treated group of severely obese patients., Methods: We considered 253 RYGB and 142 SG performed between 2007 and 2010. At 1- and 2-year control follow-ups, weight was measured and blood samples were drawn. The control group of 199 obese patients received lifestyle intervention and weight was measured at 1 and 2 years post-intervention between 2002 and 2006. We retrospectively collected fracture data for all patients through the end of 2016., Results: At follow-ups, the mean serum 25(OH)D and albumin levels were within reference ranges and were similar between the RYGB and SG groups. Serum median vitamin B12 level was significantly higher in the SG group compared with the RYBG group, 319 versus 286 pmol/L at 2 years, respectively, p = 0.04. The cumulative risk for fracture was higher in the bariatric groups compared with the control group. The Cox multivariate model showed higher age, bariatric surgery, and lower body mass index (BMI) at the 2-year control increased the risk for fracture after obesity treatment., Conclusion: Vitamin 25(OH)D, B12, and albumin levels were mainly within recommended levels during the 2 years after bariatric surgery. The cumulative fracture risk was higher in bariatric patients.

Objective: Data on the effect of gender on the interpretation of the GHRH plus arginine stimulation test (GHRH+ARG test) is controversial. We validated the GHRH+ARG stimulation test in control subjects and patients with organic or idiopathic pituitary disease and a suspicion of adult growth hormone deficiency (AGHD) using the Immulite 2000 XPi GH assay., Design: We studied 126 apparently healthy adults (median age 38.8years) and 34 patients with a suspicion of AGHD (median age 42.2years). Identification of AGHD with the GHRH+ARG test was investigated with commonly accepted BMI-related consensus cut-off limits for peak GH concentrations. Serum samples collected during the GHRH+ARG test were analysed for GH in 2014-2015. Serum IGF-1 concentrations were studied as a reference., Results: In 14 of 65 (22%) control males the GH peak value was below the BMI-related cut-off limits for GH sufficiency indicating a false diagnosis of AGHD. All control females had a normal GHRH+ARG response. Median peak GH response was significantly (p<0.001) higher in female (39.3μg/L) than in male controls (21μg/L). According to consensus cut-offs all but one young female patient had a deficient response compatible with a diagnosis of AGHD., Conclusions: The GH response to stimulation by GHRH+ARG is gender-dependent, being lower in healthy males than in females. Gender should be considered when defining cut-off limits for peak GH concentrations in the GHRH+ARG test. The presently used BMI-related cut-off levels will lead to a significant misclassification of males as GH deficient., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Although trends in many physical characteristics and cognitive capabilities of modern humans are well-documented, less is known about how personality traits have evolved over time. We analyze data from a standardized personality test administered to 79% of Finnish men born between 1962 and 1976 ( n = 419,523) and find steady increases in personality traits that predict higher income in later life. The magnitudes of these trends are similar to the simultaneous increase in cognitive abilities, at 0.2-0.6 SD during the 15-y window. When anchored to earnings, the change in personality traits amounts to a 12% increase. Both personality and cognitive ability have consistent associations with family background, but the trends are similar across groups defined by parental income, parental education, number of siblings, and rural/urban status. Nevertheless, much of the trends in test scores can be attributed to changes in the family background composition, namely 33% for personality and 64% for cognitive ability. These composition effects are mostly due to improvements in parents' education. We conclude that there is a "Flynn effect" for personality that mirrors the original Flynn effect for cognitive ability in magnitude and practical significance but is less driven by compositional changes in family background., Competing Interests: The authors declare no conflict of interest.

Background: Few studies have examined weight loss sustainability after sleeve gastrectomy (SG). The purpose of this study was to determine long-term outcome after SG and gastric bypass (GBP) and learn whether preoperative weight loss and binge eating behavior can be used to predict outcome., Materials and Methods: Together, 257 patients (64 % women) were operated, 163 by GBP and 94 by SG. Binge eating was assessed by binge eating scale (BES) and preoperative weight loss was advised to all, including very low-calorie diet for 5 weeks. Postoperative visits took place at 1 and 2 years, and long-term outcome was at median 5 years (range 2.29-6.85). Multivariate linear regression analysis was used to predict outcome at 2-year and long-term control., Results: Median age was 48 years, weight 141.1 kg, and BMI 48.2 kg/m(2). Preoperative weight loss was median 4.9 % before GBP and 3.8 % before SG, P = 0.04. Total weight loss at year one was 24.1 % in GBP and 23.7 % in SG (P = 0.40), at year two 24.4 and 23.4 % (P = 0.26), and at long-term control 23.0 and 20.2 % (P = 0.006), respectively. Weight was analyzed in 93, 88, and 89 % of those alive, respectively. BES did not predict weight outcome, but larger preoperative weight loss predicted less postoperative weight loss at 2 years., Conclusion: On long term, weight loss was better maintained after GBP compared with SG. Binge eating behavior was not a significant predictor, but larger preoperative weight loss predicted less postoperative weight loss for the next 2 years.

Objective: Intermittent dosing may improve adherence to vitamin D therapy. Dosing regimen should maintain optimal serum 25-hydroxyvitamin D (25OHD) levels over all the year. We compared two dosing regimens, the primary outcome being the percentage of 25OHD measurements reaching the targets of 75 nmol/l or 50 nmol/l after baseline., Design: Randomized, placebo-controlled parallel group comparison., Patients: Sixty women aged 75·0 ± 2·9 years., Interventions: 100 000 IU (group 1D) or 200 000 IU (2D) of vitamin D3 or placebo orally every 3 months plus calcium 1 g daily for 1 year., Measurements: Serum 25OHD, 1,25-dihydroxyvitamin D, PTH, sclerostin, ionized calcium, urinary calcium, renal function, bone turnover markers., Results: Serum 25OHD increased, but the difference between two doses was of borderline significance (P = 0·0554; area under curve analysis). Immediate postadministrative increases were higher in the 2D vs 1D group (P < 0·05) after 3 and 6 months' dosing. In the 1D and 2D groups, 51·2% and 57·7% of all on-treatment measurements reached the target of 75 nmol/l. PTH levels differed marginally (P = 0·0759) due to tendency to lowering immediately after vitamin D boluses. Urinary calcium differed between the groups (P = 0·0193) due to increases 1 week after vitamin D dosing., Conclusions: The doses of 100 000 or 200 000 IU of oral cholecalciferol every 3 months were not capable of stabilizing 25OHD levels over the target of 75 nmol/l over the year. To improve the efficacy of high-dose vitamin D therapy, the interval between boluses has to be shortened instead of increasing their size., (© 2016 John Wiley & Sons Ltd.)

Background: Weight lost by obese patients is almost always regained over time. Extended treatment may improve maintenance, but solid evidence is lacking., Purpose: We determined effectiveness of maintenance therapy after a weight loss program., Methods: Together 201 patients (mean age 47 years and BMI 42 kg/m(2), 71% women) were randomly assigned to either a 17-week weight loss program followed by a one-year maintenance program or to a weight loss program without subsequent maintenance intervention. The weight loss program included behavior modification and a very-low-calorie diet, and maintenance program behavior modification. The primary outcome measure was percentage of patients with 5% or more weight loss at the end of maintenance (week 69) and one year later (week 121). Secondary outcomes were weight related changes in lifestyle and quality of life., Results: At week 69, 52% of the patients with and 44% of those without maintenance program had lost weight ≥5%, P = 0.40, and, at week 121, 33% and 34%, P = 0.77, respectively. At week 121 secondary outcomes did not differ between the groups among those successfully followed up., Conclusions: This one-year maintenance program was not effective in preventing weight regain in severely obese patients. Trial Registration. This trial is registered under clinicaltrials.gov Identifier: NCT00590655.

X-linked hypophosphatemia (XLH) is caused by mutations in PHEX. Several other genetic forms of hypophosphatemia have also been described. These disorders share variable clinical presentation ranging from mild hypophosphatemia to severe lower extremity bowing. We report on a 43-year-old woman with short stature, painful leg deformities, and poor dentation. Her biochemical profile showed hypophosphatemia with renal phosphate wasting. Due to unusually severe clinical presentation and absence of mutations in Sanger sequencing of the PHEX gene, quantitative multiplex ligation-dependent probe amplification was performed. A large deletion within the PHEX gene encompassing exons 8 to 11 was identified. We generated a specific junction fragment using long-range PCR and sequenced the junction fragment to determine the exact deletion breakpoints. We found a heterozygous novel complex re-arrangement involving gross deletions, insertions, and inversion of PHEX (hg19:g.22,115,003&#95;22,141,395del;g:22,145,536&#95;22,150,789delinsCins22,114,640&#95;22,114,698invinsA). Thus, the complex re-arrangement including a deletion of coding exons 8 to 11 of the PHEX can be regarded as the cause of XLH in the patient reported here. Phosphate and active vitamin D treatment was initiated with subsequent relief in bone pain and physical improvement. This report expands the spectrum of clinical severity underlying genetic defects in XLH and highlights the importance of conventional medical therapy even at adult age. Furthermore, our findings underscore the importance of search for gene deletions in patients with suspected XLH., (© 2014 Wiley Periodicals, Inc.)

This paper studies the cross-border health and productivity effects of alcohol taxes. We estimate the effect of a large cut in the Finnish alcohol tax on mortality, alcohol-related illnesses and work absenteeism in Sweden. This tax cut led to large differences in the prices of alcoholic beverages between these two countries and to a considerable increase in cross-border shopping. The effect is identified using differences-in-differences strategy where changes in these outcomes in regions near the Finnish border are compared to changes in other parts of northern Sweden. We use register data where micro level data on deaths, hospitalisations and absenteeism is merged to population-wide micro data on demographics and labour market outcomes. Our results show that the Finnish tax cut did not have any clear effect on mortality or alcohol-related hospitalisations in Sweden. However, we find that workplace absenteeism increased by 9% for males and by 15% for females near the Finnish border as a result of the tax cut., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Objective: A peak GH less than 3 μg/L to insulin tolerance test (ITT) is commonly used as a threshold indicating severe adult GH deficiency (GHD). This cut-off is based on results obtained by polyclonal radioimmunoassays preferably under standard conditions at hospital. Our aim was to evaluate the validity of this cut-off limit using two currently used immunometric GH assays and to compare GH responses in the ITT and the GH releasing hormone + arginine (GHRH + ARG) test in healthy adults at our outpatient endocrine unit., Design: ITT was performed on 73 subjects and the GHRH + ARG test on those 28 who showed insufficient response to the ITT., Methods: GH was measured by an immunofluorometric and immunochemiluminometric assay., Results: GH peak above 3 μg/L was observed in 56% of the healthy volunteers with adequate hypoglycemia in the ITT. Among the 28 subjects with a peak GH below 3 μg/L, only two overweight men had a GH peak response below the commonly used cut-off limit of 9.1 μg/L in the GHRH + ARG test., Conclusions: Lean healthy adults could erroneously be classified as GH deficient by the ITT while their results in the GHRH + ARG test were normal. The GH results are highly dependent on the immunoassay used, but false positive results in the ITT are often obtained even if lower cutoff limits determined on the basis on the calibration of the GH assay are used. Confounding factors seemed to blunt the GH response to the ITT more than to the GHRH + ARG test at our outpatient clinic., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

The study group consisted of 96 patients who had used a medication for type 2 diabetes; of them, 33 had undergone gastric sleeve surgery and 63 bypass surgery. Both surgical methods resulted in a similar weight loss among the patients. In follow-up 39 out of 88 patients were able to manage without antidiabetic drugs two years after surgery. The costs of antidiabetic drugs two years after surgery were 79% lower than before the operation. Weight reduction surgery decreases the need for antidiabetic drugs. The greatest cost-efficiency is achieved by targeting weight-loss operations to patients using insulin therapy.

Objective: Daily dosing of vitamin D supplements may be difficult among older people. Infrequent administration of 'megadoses' controlled by health care personnel may overcome adherence problem. We compared the efficacy and safety of two oral dosages (800 IU daily or 97333 IU four monthly) of vitamin D(3) resulting in the equal annual dose of 292000 IU., Design: Randomized, double-blind, double-dummy parallel group comparison. Patients Forty women aged 69.3-78.8 years., Interventions: Vitamin D(3) 400 IU twice daily (D group) or vitamin D(3) oil 97333 IU every 4 months (4 M group) for 1 year. All received 1 g of calcium daily., Measurements: Serum 25-hydroxyvitamin D(3) [25(OH)D(3)] in relation to the target levels of 50-75 nmol/l, PTH, serum type I procollagen aminoterminal propeptide (PINP), serum and urine calcium, renal function., Results: A quantity of 25OHD(3) increased more in D group than in 4 M group (P < 0.0001). All participants in D group and 67% in 4 M group had 25(OH)D(3) above 50 nmol/l at 12 months; the target level of 75 nmol/l was reached by 47% and 28% respectively. PTH did not show any seasonal perturbation in either group. PINP declined and urinary calcium rose similarly in the study groups over time (P < 0.0001). Renal function did not worsen in either group., Conclusions: In terms of serum 25(OH)D(3) concentrations, 800 IU daily was more efficient than a 97333 IU every 4 months. However, to increase adherence, the latter is still worth developing. Both treatments increased urinary excretion of calcium, but did not worsen renal function.

Objective: Concentrations of 50 and 75 nmol/l are proposed as serum 25-hydroxyvitamin D (25(OH)D) target for older people from the view of bone health. We evaluated vitamin D status of elderly Finnish women in light of these definitions, its relationship to bone mineral density (BMD) and turnover, and improvement by summer sunshine., Design: Population-based study., Methods: A total of 1604 ambulatory women aged 62-79 years were studied; 66% used vitamin D supplements. Serum 25(OH)D(3) was measured with HPLC before and after summer, and heel BMD in spring. In subgroups, serum parathyroid hormone (PTH) and type I procollagen aminoterminal propeptide (PINP) were analyzed., Results: In spring, 60.3% of the women had 25(OH)D(3)

Objectives: The purpose of this study was to compare the health-related quality of life (HRQoL) of elderly users and non-users of hormone therapy (HT)., Subjects and Methods: Subjects were participants in an ongoing intervention study, which is aimed at elucidating the effectiveness of an educational program in the prevention of osteoporosis. A random sample (n=4200) of the female population in Southern Finland within the age group of 60-70 years was drawn from the population register and invited to take part in the trial; 2181 (52%) accepted the invitation and were randomized either to the educational program or to a control group. In 2002 all 2181 participants were asked by a postal survey about HRQoL (generic15D), education, profession, climacteric symptoms, use of HT, chronic diseases and medication. Of the 1663 respondents (76% of the participants; 40% of the original cohort) 585 (mean age 67.5 years) were HT users and 1078 (mean age 68.9 years) non-users., Results: After standardizing for age, education, number of continuous medication and ongoing diseases HRQoL of HT users was significantly better on the dimensions of usual activities, vitality and sexual activity. The effect of HT on overall HRQoL on a 0-1 scale was positive, but neither statistically significant nor clinically important. The number of medication and diseases had a statistically significant negative effect, but higher education a positive, but statistically non-significant effect on HRQoL overall., Conclusions: Among elderly women HT use has a statistically significant positive effect on some dimensions of HRQoL, but not on HRQoL overall. To improve HRQoL is not an indication for elderly postmenopausal women to use HT.

Background: Native BMP extracts from reindeer effectively induce ectopic new bone formation in vivo, but their bone healing properties have not yet been evaluated. We investigated the effect of reindeer BMP extracts on the healing of long bone defects., Methods: The implants tested contained 5 mg or 10 mg of unsterilized BMP extract from reindeer and 10 mg of gamma-sterilized BMP extract administered with collagen carrier (Lyostypt, B. Braun, Germany). 70 micro g of rhBMP-2 with collagen carrier (InductOs; Wyeth Europa) served as positive control, and collagen implants (Lyostypt) and untreated defects served as negative controls. New Zealand White rabbits with 1.5 cm of critical-size radius bone defects were used, with 8 weeks of follow-up., Results: Radiographic analysis showed bone formation (BF) to be higher in all groups containing BMPs than in the untreated controls. BF was also higher in the rhBMP-2 group, and marginally higher in the group treated with 10 mg of unsterilized reindeer BMP extract (p = 0.06) as compared to the collagen controls. Bone union (BU) was better in the unsterilized BMP extract groups and rhBMP-2 group than in the untreated controls. BU was also better in the implants with 10 mg of unsterilized reindeer BMP extract and rhBMP-2 than in the collagen-treated implants. The mean area of new bone at the site of the defect proved to be higher in all implants containing BMP than in the untreated defects. It was also higher in the groups with 10 mg of unsterilized reindeer BMP extract and rhBMP-2 than in the collagen-treated controls. Mechanical tests showed torsional stiffness of the bones to be higher in the group with 10 mg of unsterilized BMP extract than in the collagen group. The mean cross-sectional bone area measured by pQCT densitometry was higher in the rhBMP-2 group than in the collagen group. The mean bone density at the defect area was higher in the group with 10 mg of unsterilized BMP than in the rhBMP-2 group., Interpretation: We conclude that both reindeer BMP extract and rhBMP-2 induced improved healing of the rabbit radius bone defects at the doses used. Gamma sterilization of reindeer BMP extract reduced osteoinductivity slightly, but not significantly.

Background: Diagnosis and follow-up of acromegaly is based on measurements of serum growth hormone (GH) concentrations during an oral glucose tolerance test (OGTT). A nadir value <1 microg/L is commonly used to define a normal response, but some authors suggest lower cutoff values., Methods: To compare the results and subsequent patient classification obtained with 3 GH assays, we obtained basal serum samples from 78 apparently healthy adult controls (43 women and 35 men; median age, 32.5 years) and from 71 treated (44 women and 27 men; median age, 55.2 years) and 7 untreated acromegaly patients (4 women and 3 men; median age, 54.6 years), and OGTT was performed on all patients and on 72 of the 78 controls. GH was determined by 2 immunometric assays-a double monoclonal (AutoDELFIA; Wallac) and a monopolyclonal (Immulite 2000; DPC) assay-and in a limited set of samples by an RIA (Spectria RIA; Orion)., Results: There was a strong correlation (r = 0.995; P < 0.001) between the 2 immunometric methods, but the results obtained with the Immulite 2000 were, on average, 1.4-fold higher than those obtained with the AutoDELFIA. At concentrations around the cutoff (1 microg/L), however, the difference was approximately 2-fold. Overall, the Orion RIA method also showed a good correlation (r = 0.951-0.959) with the other methods, but it did not measure concentrations <2 microg/L. Women had higher basal and OGTT nadir GH concentrations than men., Conclusion: Reference intervals should be determined separately for each method, and the need for establishing sex-specific reference values should be investigated.

Bone morphogenetic proteins (BMPs) are members of the TGF-beta superfamily. They are capable of inducing ectopic bone formation. Until now, the main interest has been focused on mammalian osteoinductive BMPs, and there are no reports of native BMP extracts of birds. In this study, we isolated and characterized native BMPs of ostrich (Struthio camelus) and compared them with identically isolated native bovine (cow) and reindeer BMPs with regard to BMP pattern and osteoinductive capacity. The ostrich BMP pattern differed markedly from that of cow and reindeer BMP in non-reduced SDS-PAGE, reduced SDS-PAGE and Western blot. The differences in isoelectric focusing analysis were smaller. However, the ostrich BMP extract had a peak at pH 5.1, clearly differing from the BMPs of cow and reindeer. The osteoinductive capacity and density of ectopic bone, induced by BMP extracts in a mouse thigh muscle pouch, were determined radiographically. The ostrich BMP extract displayed significantly lower osteoinductive capacity and density of induced bone than the bovine and reindeer BMP extracts. In conclusion, our results indicate that the BMP pattern of birds differs considerably from that of mammals, and that the osteoinductive capacity of BMPs and the density of induced bone are lower in birds than in mammals. They also suggest that the bone metabolism of birds is adapted to make light bones suitable for flying.

Background: Bone morphogenetic proteins (BMPs), which are capable of stimulating the production of new bone, must be sterilized before preclinical and clinical use to reduce the risk of infections and associated complications. In this study, we investigated the effects of gamma sterilization on the osteoinductivity of native reindeer BMP extract in the Balb/C mouse thigh muscle pouch model., Methods: 5 mg of native reindeer BMP extract and 5 mg of bovine serum albumin were administered separately either in gelatine capsules or mixed with gelatine as injections. The dose of gamma irradiation was 4.1 Mrad. Unsterile capsules and injections served as controls. New bone formation was evaluated based on the incorporation of Ca45 and also radiographically 3 weeks after implantation., Results: Albumin-containing implants and injections did not induce new bone formation, as monitored in radiographs. Gamma sterilization did not reduce the osteoinductivity of native BMP extract in capsules, but a significant decrease in osteoinductivity--measured as area (50%) and Ca45 incorporation of new bone (27%)--was seen after injection. Gamma sterilization had no effect on the optical density of new bone induced by native BMP extract administered in capsules or by injection., Interpretation: We conclude that, as gamma irradiation did not reduce the osteoinductivity of reindeer BMP extract in gelatine capsules, this method appears to be suitable for sterilization of BMPs to be given in capsule form. Native reindeer BMP extract was more sensitive to irradiation in soluble collagen (gelatine) than BMP in gelatine capsules. This finding must be given serious consideration regarding treatment of patients, but the remaining activity may be sufficient for the induction of bone formation in preclinical and clinical situations.

Objective: To study the impact of a weight-loss program on sex hormones and sexual function among 38 middle-aged obese men (BMI >or=35 kg/m(2))., Research Methods and Procedures: A randomized controlled clinical trial was conducted. The treatment group (n = 19) participated in a 4-month weight-loss program including 10 weeks on a very-low-energy diet (VLED) and 17 behavior modification visits. There was no intervention in the control group (n = 19). Both groups were followed for 8 months, i.e., 22 weeks after the active weight loss in the treatment group. The outcome measures (weight, sex hormones, sexual function, leptin, and metabolic variables) were obtained at baseline and at three time-points during follow-up., Results: The mean weight loss in the treatment group was 21 kg at the end of the 10-week VLED. At the end of follow-up, the maintained weight loss was 17 kg of baseline weight. The control group was weight stable throughout the study. In the treatment group, increases in sex hormone-binding globulin, testosterone, and high-density lipoprotein-cholesterol, as well as decreases in insulin and leptin, were maintained until the end of follow-up, although with VLED, the level of several hormones and metabolic variables improved transiently during the rapid weight loss. There were no significant changes in the questionnaire scores on sexual function in either group., Discussion: We conclude that obese men lose weight and increase their serum testosterone level on a weight-loss program with VLED and behavior modification. However, they do not change their sexual function scores.