Correction to: Conducting an observational study during an economic crisis: analysis of the treatment and follow-up phase of Greek patients participating in the ExFOS study.

Unfortunately in the original publication, the affiliation of the author N. Papaioannou was incorrectly provided.

Conducting an observational study during an economic crisis: analysis of the treatment and follow-up phase of Greek patients participating in the ExFOS study.

OBJECTIVE: We present the subanalysis of the Greek cohort of the Extended Forsteo Observational Study (ExFOS), a multicenter, non-interventional, prospective, observational study evaluating the effect of teriparatide on fractures, back pain (BP), health-related quality of life (HR-QoL), and safety and compliance, in patients with osteoporosis treated for up to 24 months, with a post-treatment follow-up of at least 18 months. DESIGN: A total of 439 osteoporotic patients (92.2% female) were enrolled in Greece. New or worsened fractures, based on their physicians' assessment, as well as patients' self-assessment of HR-QoL and BP, compliance, and safety profile, were captured by validated questionnaires. RESULTS: In the ExFOS Greek cohort, fracture rates were low and mean bone mineral density (BMD) was numerically improved. Compliance with teriparatide remained high throughout the study, with 81.5% of subjects completing treatment. Only 0.7% of patients reported discontinuation due to adverse effects. A sustainable improvement in patient-perceived BP and HRQoL throughout treatment and follow-up was similar to that achieved by the European Forsteo Observational Study (EFOS). A lower than expected percentage of patients using antiresorptives following teriparatide was recorded. CONCLUSIONS: ExFOS reproduces the outcomes of EFOS, with a 6.5-year time interval between studies, in comparable cohorts of osteoporotic patients. Data should be interpreted in the context of observational study data collection, although summary statistics computed at each time point may overstate drug effect.

Teriparatide use during an economic crisis: baseline data from the Greek cohort of the Extended Forsteo Observational Study (ExFOS).

BACKGROUND: The Extended Forsteo Observational Study (ExFOS) is a multinational, non-interventional, prospective, observational study that aims to provide real-life data on patients with osteoporosis treated with teriparatide for up to 24 months. It includes the new indications of osteoporosis in men and glucocorticoid-induced osteoporosis (GIOP). We describe the Greek subpopulation enrolled in this study and compare it with a similar cohort from the previous European Forsteo Observational Study (EFOS). METHODS: Baseline data were collected from the Greek cohort of ExFOS. Data included demographic characteristics, medical and osteoporosis history, disease status, prior use of medications, back pain and quality of life. RESULTS: Baseline data for 439 patients, enrolled at 31 sites, indicated the majority of patients were females (92.3%), elderly [mean (standard deviation; SD) age 70.1 (9.8) years] and slightly overweight [mean (SD) body mass index 26.7 (4.3) kg/m(2)], with very low bone mineral density (mean T-score <-3 in lumbar spine or total hip) and at least one previous fracture (55.1% of patients). Of the 439 patients, 19.8% were osteoporosis treatment naïve, 88.4% had experienced back pain during the previous 12 months, 68.1% had experienced back pain at least fairly often during the previous month and 50.9% reported moderate to severe limitation of activities due to back pain, with a mean (SD) of 4.2 (7.7) days spent in bed because of back pain during the previous month. Most baseline characteristics were numerically similar between the female ExFOS and EFOS cohorts; however, the rate of enrolment was faster in ExFOS (by approximately 45%) and a history of fracture was recorded in 53.8% of female patients in ExFOS versus 74.5% in EFOS. CONCLUSIONS: Greek patients prescribed teriparatide in ExFOS had severe osteoporosis with a high risk of fractures and back pain. Female patients shared similarities with EFOS counterparts, reflecting a constant prescribing profile for use of teriparatide, although a noticeable difference in fracture history between the two study cohorts may indicate a change towards prescribing in less severely affected patients. The economic crisis in Greece did not appear to affect patient enrolment. Data are interpreted in the context of an observational setting.

The "depressive" face of osteoporosis and the "osteoporotic" face of depression.

Osteoporosis and depression are two chronic diseases that affect large population groups with great impact on morbidity, mortality and quality of life. An association between osteoporosis and depression has been described in the literature. Definitely, limited data suggest that osteoporosis may enhance depressive symptoms, while far more studies have shown that depression adversely affects bone density and increases fracture risk. However, neither causation nor a firm pathophysiological connection has been established. Thus the correlation of these diseases is still under research. This review comments on a plausible causative relationship and underlying mechanisms that might elucidate the link between two very common diseases. We describe the possible impact of osteoporosis on moods and the (better established) effect of depression on bone health. We also describe the effect of medication and review hormonal and cellular signals that may explain this effect.

Clinical outcomes and costs for patients with type 2 diabetes mellitus initiating insulin therapy in Greece: two-year experience from the INSTIGATE study.

AIMS: To evaluate the quality of metabolic control, clinical outcomes, resource costs, and quality of life among patients with type 2 diabetes mellitus (T2DM), who initiated insulin for the first time as part of routine clinical practice. METHODS: The INSTIGATE study is a prospective, multicentric, observational study of patients initiating insulin treatment. This sub-cohort analysis focuses on Hellenic outcomes. RESULTS: At baseline, 263 Greek patients were enrolled just before initiating insulin for the first time. At the 6-month visit, 237 patients (90.1%) remained and consented to an additional 18-month observation period. In these 237 extension patients, over the 24-month post-initiation period, HbA1c (mean(SD)) decreased from 9.7%(1.6%) to 7.1%(0.9%) and body weight and BMI increased (+3(6)kg and +1.1(2.2)kg/m(2), respectively). At each post-baseline visit approximately one in five patients reported ≥1 episodes of hypoglycaemia in the preceding 3-6 months. Median total costs fluctuated from 438€ at baseline to 538€ up to 6 months and 451€ at 24 months; mean costs were 496(383)€, 573(276)€ and 485(247)€, respectively. CONCLUSIONS: In this cohort, insulin treatment seems to be effective with little long-term impact on cost. Findings should be interpreted in the context of an observational study.

Hashimoto thyroiditis: A "true" adenoma visualized as a hot nodule in the presence of overt hypothyroidism.

A 63 years old woman with Hashimoto's thyroiditis, on thyroxin treatment presented imaging studies concordant with a multinodular goiter, a "hot" nodule in the left lobe and partial suppression of the right lobe. After thyroxin withdrawal overt hypothyroidism developed, yet the patient's imaging studies were not altered. This is a case of hypothyroidism in a patient with Hashimoto's thyroiditis, multinodular goiter and a concomitant "hot nodule", showed on scintigraphy, as a functioning adenoma in a non functioning thyroid. This finding is quite rare as no specific percentages are mentioned in the literature. To our knowledge this is the first such case described in Greece.

Irreversible end-stage heart failure in a young patient due to severe chronic hypocalcemia associated with primary hypoparathyroidism and celiac disease.

BACKGROUND: Chronic hypocalcemia may cause electrocardiographic (ECG) changes and mimic acute myocardial infarction. It has also been associated with reversible cardiac dysfunction. On the other hand cardiomyopathy and heart failure have been reported in patients with idiopathic hypoparathyroidism or celiac disease. CLINICAL CASE: A 39-year-old male was admitted to the emergency room with acute retrosternal pain and dyspnea. He exhibited severe hypocalcemia and acute renal failure. High creatine kinase (CK) levels did not correlate with biomarkers of myocardial necrosis (negative troponin test, heart type creatine kinase isoenzyme (CK-MB) < 1% of CK value). The ECG showed an extremely long QT interval (0.6 sec) and T-wave inversions on V(4) through V(6). The left ventricular ejection fraction (LVEF) was as low as 25%, while coronary angiography was normal. Investigation of the hypocalcemia revealed primary hypoparathyroidism (Parathyroid hormone (PTH) < 3 pg/ml) and concomitant celiac disease with positive antigliadin and endomysial antibodies. The cardiovascular episodes and the dilated heart failure were attributed to the chronic hypocalcemia since no other cause was found. The correction of hypocalcemia has not been sufficient to reverse the end-stage heart failure after more than 6 months of treatment, even though ECG abnormalities have receded, implying permanent cardiac impairment. CONCLUSION: This case demonstrates an unusual clinical condition where 2 calcium homeostasis disorders led to severe hypocalcemia with clinical manifestations of end-stage heart failure. The severe cardiac failure appeared to be nonreversible after calcium repletion suggesting permanent cardiac muscle dysfunction due to associated cardiomyopathy.

Corpus callosum aplasia in a young patient with a parathyroid adenoma.

A young man with primary hyperparathyroidism due to a parathyroid adenoma and aplasia of the corpus callosum is presented. We hypothesize a possible genetic association of the two pathologies: a proportion of the sporadic parathyroid adenomas are associated with genetic abnormalities of chromosome 11 and in some cases of corpus callosum aplasia, aneuploidy or polyploidy of this chromosome has been described.

Vitamin D deficiency in the elderly in Athens, Greece.

Vitamin D deficiency characterized by low 25-hydroxyvitamin D [25(OH)D] levels has been found to be prevalent among the elderly in many regions of the world. To investigate the vitamin status in elderly community-living persons in Athens, we measured 25(OH)D and parathyroid hormone (PTH) in elderly persons and young blood donors during the winter and summer. The changes in these parameters in a subgroup of the elderly were studied longitudinally. The blood donors had mean 25(OH)D levels similar in winter and summer and twice as high in winter compared to the elderly. At the end of the winter, about 20% of the elderly had severe vitamin D deficiency, with 25(OH)D below 25 nmol/l, and only 6.5% could be judged as vitamin D sufficient with values above 80 nmol/l. The situation improved during summer, although 64.8% of the elderly continued to have levels below 80 nmol/l. Mean plasma PTH in the elderly in summer was not different from that of blood donors; however, it was doubled during the winter. Regression of PTH on 25(OH)D demonstrated that PTH starts to rise when 25(OH)D falls below approximately 80 nmol/l. We conclude that severe vitamin deficiency associated with secondary hyperparathyroidism is not uncommon in the elderly in Athens during the winter; it subsides during summer, although only one-third of the elderly population attain vitamin D sufficiency during summer. We found that a threshold value of 25(OH)D exists at approximately 80 nmol/l, below which secondary hyperparathyroidism ensues, as described previously.

Virilization caused by an ectopic adrenal tumor located behind the iliopsoas muscle.

OBJECTIVE: Virilization due to androgen-secreting neoplasms in women is a result of androgen overproduction from benign or malignant tumors that are found in the ovaries or rarely in the adrenal glands. Virilizing tumors that arise from ectopic adrenal tissue are extremely rare. We describe a very rare case of an ectopic androgen-producing adrenal tumor. DESIGN: Case report study. SETTING: Endocrinology outpatient department of university-affiliated teaching hospital. PATIENT(S): A 45-year-old woman with symptoms of virilization of abrupt onset and rapid progression, with high serum androgen hormone levels and normal glucocorticoid secretion. INTERVENTION(S): Basal hormonal levels, stimulation and suppression tests, imaging techniques, and selective venous sampling. MAIN OUTCOME MEASURE(S): Localization and surgical removal of the source of androgen production. RESULT(S): An ectopic mass was detected behind the left iliopsoas muscle. The patient was operated on and an oblong-shaped lesion, weighing 6 g, was removed. Histologically, the tissue was identified to be of adrenal origin. Postoperatively the androgen levels decreased to normal levels. CONCLUSION(S): This case illustrates difficulties in detecting and localizing the rare contingence of an ectopic adrenocortical androgen-secreting tumor.

L-thyroxine therapy attenuates the decline in serum triiodothyronine in nonthyroidal illness induced by hysterectomy.

It is controversial whether the administration of thyroid hormone to patients with nonthyroidal illness has any beneficial effect. Two groups of patients undergoing abdominal hysterectomy under the same general anesthesia were studied. Group A consisted of 15 women taking chronically l-thyroxine therapy (1.8 mug/kg daily), and group B (control) consisted of 16 apparently healthy euthyroid women taking placebo. Thyroid hormones, cortisol, and interleukin (IL)-6 were measured 1 day before and 1, 2, 3, and 6 days after surgery. Total triiodothyronine (TT(3)) decreased to a significantly greater degree (P <.05) and for a longer period of time in group B than in group A. The significant increase of reverse T(3) (rT(3)) noted early in group B failed to reach the baseline levels until the end of the study, whereas in group A, rT(3) returned to the preoperative values by day 2. Both groups had similar free thyroxine (FT(4)) at baseline. FT(4) increased significantly at day 1 and remained significantly elevated throughout the postoperative period in group B only. Serum TT(4), thyroid-stimulating hormone (TSH), and cortisol did not change significantly in either group. In all patients, IL-6 increased significantly to a peak value at day 1, showing a slow decrease thereafter. A stronger negative correlation was found between T(3) and IL-6 in group B than in group A (r = -.66, P <.0001 v r = -.38, P <.001, respectively) and a strong positive correlation was observed between rT(3) and IL-6 in group B only (r =.57, P <.001). The long-term treatment with T(4) seems to attenuate the decrease of serum T(3), which occurs during the development of nonthyroidal illness postoperatively. The elevation of IL-6 accounted for a greater proportion of the variations of the T(3) and rT(3) in the control group B than in the T(4)-treated group A.