[INTRODUCTION - MERLIN (Management of Osteoporosis in Elderly with Calcitonin) is an open-label, multicenter, prospective, follow-up study conducted in Hungary, part of which is to assess the impact of treatment with Miacalcic, - an intranasal salmon calcitonin, on the quality of life (QoL) among patients with osteoporosis. In this paper we report the preliminary results of the MERLIN study. PATIENTS - The study initially involved 1949 senior patients (aged >65 years) to whom calcitonin was prescribed for osteoporosis according to the application instructions. Patients presented at outpatient clinics and consisted of two groups; they were either newly diagnosed or they had been receiving a therapy for osteoporosis other than calcitonin. METHODS - This latter group discontinued their previous treatment and all patients received 200 IU intranasal salmon calcitonin (SCT) once daily for three months. Patient and physician questionnaires were used to collect information on the patients' QoL (EQ-5D VAS) and their general well-being at baseline and at follow-up visits at week 4 and week 12. RESULTS - Calcitonin use was associated with improvements in all EQ-5D domains and component scores as well as in VAS. Patients with previously known osteoporosis who, switched to calcitonin therapy achieved better results (0,046 QALY), than the newly diagnosed patients (0,0405 QALY). CONCLUSIONS - We conclude that intranasal SCT 200 IU daily is safe and effective in improving QoL of both, male and female patients with low bone mineral density.The conclusions that can be drawn from this study are limited due to the lack of a control group and to the unblinded design. Further placebo-controlled studies are needed to confirm these results. Nevertheless, our study was the first in Hungary to evaluate the quality of life impact of an osteoporosis treatment, and hopefully it will be followed by more such studies directed to other osteoporosis treatments.]

[INTRODUCTION - In addition to several other causes constitutional factors play an important role in the development of osteoporosis.Various aspects of bone metabolism were examined to explain the differences in bone density between women with low and high body mass index (BMI). PATIENTS AND METHOD - One hundred and ninetytwo postmenopausal women were included in the study. Bone density was measured by forearm densitometry.To assess bone formation, serum osteocalcin levels were measured, while the rate of bone absorption was estimated from C-terminal telopeptide levels of collagen type I measured in urine and blood. RESULTS - The prevalence of osteoporosis was higher in women with low BMI than in those with normal or higher BMI. Bone metabolism - both formation and absorption - was increased in both groups, however, in women with low BMI this increase was more pronounced and bone metabolism tended to be shifted to absorption compared to patients with normal or higher BMI. CONCLUSION - Postmenopausal lean women have accelerated bone metabolism compared to obese women. This fact and the shift to absorption may be the main reasons for the higher frequency of osteoporosis found by densitometry in women with low BMI than in those with higher BMI.]

[INTRODUCTION - Data on bone mineral density (BMD) in diabetes mellitus are contradictory in the literature. Early studies described a decreased bone mineral density in type 1 diabetes mellitus (T1DM), but recent studies report no osteopenia in T1DM.The BMD may depend on the quality of treatment for diabetes mellitus and on the presence of chronic complications. In type 2 diabetes mellitus (T2DM) the BMD is not decreased, occasionally it can even be increased. PATIENTS AND METHODS - Bone mineral density was measured in 122 regularly controlled diabetic patients (T1DM: n=73, mean age: 43.6±11.1 years,T2DM: n=49, mean age: 61.8±9.8 years) by dual energy X-ray absorptiometry at the lumbar spine and at the femur. Results were compared to those of 40 metabolically healthy control persons with a mean age of 47.5±11.9 years.The patients’ carbohydrate metabolism was assessed by the average HbA1c level of the last three years.These values were 7.9±1.4 % in T1DM, and 7.5±1.7 % in T2DM. BMDs were classified based on the T-score and Z-score using the WHO criteria. RESULTS - There was no significant difference in T1DM or in T2DM compared to the reference group in the prevalence of either osteoporosis or of osteoporosis and osteopenia combined. CONCLUSION - BMD was not found to be decreased in patients with well-controlled metabolism compared to healthy controls.]

[Various medical associations issue different recommendations for the prevention and treatment of vitamin D deficiency. These significant differences are partly explained by the different definition of normal vitamin D level and the use of completely different mathematical models to predict the increase in vitamin D level as a response to therapy. According to the Institute of Medicine (IOM), the target vitamin D level is 20 ng/ml, whereas the Endocrine Society (ES) recommends 30 ng/m as the miminum target value. According to the ES, a 1 ng/ml increase of vitamin D level can be reached by a daily intake of 100 NE, while the IOM recommends 3.6 ng/ml. Moreover, the IOM states that the effect of therapy on serum level is nonlinear. These differences show that the ES and IOM have different views on the risk of adverse effects. The IOM recommends 400 IU vitamin D daily for children younger than 1 year, 800 IU for those above 70 years and 600 IU/per day for everyone else. The ES recommend 400-1000 IU daily for all infants and 1500- 2000 IU for adults. Screening, however, is not recommended by either society. To decrease uncertainty concerning the side effects of higher-dose vitamin D treatment, it is important to understand, use and support the function of the pharmacovigilance system of the pharmaceutical industry that manufactures and markets various (prescription, over-the-counter) preparations. This is what the author aims to highlight in the second part of this article. Using this system, both the doctor and the patient can help support and accept the justification of higher-dose vitamin D therapy.]

[We conducted a multicentre, prospective, single cross-sectional, 12-month, open-label study for the assessment of treatment satisfaction using TSQM (Treatment Satisfaction Questionnaire for Medication) for zoledronic acid therapy used in patients with osteoporosis, who suffered minor traumatic fractures. PATIENTS AND METHODS - In total 1736 patients from 94 centers completed the study and filled in the TSQM questionnaire at both visit 1 and visit 2. TSQM is suitable for measuring the patient’s satisfaction with a treatment, by evaluating side-effects, efficacy and convenience of the treatment and the patient’s overall satisfaction rated on a scale of 0 to 100. RESULTS - Patients included in the study previously received a mean of 1.58 other therapies for osteoporosis and their case history included a mean of 1.24 fractures. This real-life study demonstrated that even one year of zoledronate treatment significantly (p<0.0001) improved the satisfaction of patients regarding efficacy (a mean change from a score of 56.15 to 70.89) as well as the occurrence of side-effects on a TSQM score. Regarding the convenience of treatment, the mean score increased from 62.96 to 79.34 (p<0.0001), whereas the overall treatment satisfaction changed from 59.3 to 75.48 by visit 2 (p<0.0001). CONCLUSIONS - Our study demonstrated beneficial TSQM results associated with zoledronic acid treatment, which is a basic requirement for appropriate adherence as well. ]