Ca&Bone

[MOOT-COMP study - Compliance of patients with antiporotic treatment]

BORS Katalin, BOROS Erzsébet

NOVEMBER 10, 2007

Ca&Bone - 2007;10(04)

[INTRODUCTION - Several studies prove the importance of the lack of compliance in the ineffectiveness of drugs which have been tested by clinical studies. In our study we finded the reasons of leaving off the antiporotic treatment. PATIENTS AND METHODS - 1067 osteoporotic patients (91% women, 9% men) were enrolled to examine compliance and to find explanation of non-compliance. We asked the patients about medications, exercises, electrotherapy and medical aids. RESULTS - Medications were recommended for most patients and exercise was the secondary most common therapeutic method. Electrotherapy was prescribed for one third and medical aids were recommended for one fifth of the recruited patients. Two third of patients reported to take all pills, most of them suffered from bone fracture. More than one fifth of patients sometimes or often forgot to take the treatment. 10% more patients did exercises than it was recommended by the practitioner. However, only 25% of all patients did exercises appropriate frequency and at least 20 minutes per day. Electrotherapy was not prescribed by the doctors for more than half of patients on this treatment. Medical aids were not used by 10% of patients despite the recommendations. Almost one third of the enrolled patients reported a fact which disturbed keeping recommendations of the doctors. These facts were financial problems, long waiting lists and low motivation of patients for keeping recommendations. The compliance did not correlate with education and social status. The patients with multiple fractures were more comply with medications and exercises. CONCLUSION - Drawing the informed patient into decision making and knowing the therapeutic outcome are important factors for keeping therapeutic recommendations. The high fracture rate in Hungary attracts our attention for enhance patient compliance.]

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Ca&Bone

[Dear Colleagues and Readers!]

HORVÁTH CSABA

Ca&Bone

[Relationship of cardiovascular risk factors and bone status in a large adult population of the Balaton Region]

BUDAY BARBARA, IZSÓNÉ KATZ MELITTA, NAGY ELVIRA, PAPP ZSUZSA, KORÁNYI LÁSZLÓ

[BACKROUND - Numerous international studies have investigated the relationship between bone metabolism and type 2 diabetes mellitus. The results are controversial, there are those proving an increasing effect of diabetes on bone density but we know data that prove the opposite results. Our aim was to investigate the relationship between bone density, obesity and carbohydrate metabolism on a large Hungarian population. PATIENTS AND METHODS - The data from a large population screening (n=6287, mean age 56±13 years, men: n=1561, women: n=4726), carried out in the Balaton Region, Hungary, were analyzed (anthropometry, blood glucose and total cholesterol, blood pressure, calcaneus ultrasound T-score). RESULTS - Analyzing the relationship between type 2 diabetes and osteoporosis/osteopenia, we found, that the prevalence of osteopenia is significantly higher in diabetic women between 50-60 years of age than that of normal glucose tolerance, (50 vs. 36.34%, OR: 1.711, 95% CI: 1.076-2.722, p<0.022), however in different age groups and in males there were no significant differences, similar to the metabolic syndrome which did not influence the prevalence of osteoporosis/osteopenia. In normal weight (male and female) diabetic population over 60 years of age, the frequency of osteoporosis/ ostepenia was much higher, than in the normal weight normal glucose tolerance group, which difference was borderline-significant in the case of osteoporosis (63.63 vs. 26.2%, OR: 2.71, 95% CI: 0.969-7.6, p=0.054), and did not reach it with osteopenia (53.38 vs. 43.31%, p=0.359). In the same age group, within the “all glucose intolerant” and “all normal glucose tolerance” groups the prevalence of osteoporosis/osteopenia did not differ. We found significant correlation between BMI and T score only in women and it was strongest in age group of over 70 years (r=+0.23, p<0.001). CONCLUSION - Our data suggest that the increased bone density often measured in type 2 diabetic patients is actually the consequence of the accompanying obesity, and not of diabetes itself, which is rather a risk factor for bone loss.]

Ca&Bone

[Decreased bone resorption in H1-receptorantagonist treated allergic children]

FERENCZ VIKTÓRIA, BOJSZKÓ ÁGNES, PALLINGER ÉVA, LAKATOS Péter, FALUS ANDRÁS, HORVÁTH CSABA

[INTRODUCTION - Histamine receptor antagonists seems to have effect on bone metabolism according to previous studies. We investigated the bone turnover in allergic children who were treated with H1-histaminreceptor (H1R) antagonists. PATIENTS AND METHODS - The biochemical bone turnover markers [β-CrossLaps (β-CTx), osteocalcin (OCN), β-CTx/OCN ratio], parathyroid hormone (PTH) and the 25(OH)vitamin D3 were determined in 37 H1Rantagonist treated multiplex allergic children and in 21 age and gender matched healthy children. The intracytoplasmatic histidine decarboxylase (HDC), histamin, and surface H1 and H2 receptors expression were assessed by flow cytometry on peripheral leukocytes. The distribution of lymphocyte subpopulation were also determined. RESULTS - The serum OCN, PTH and 25(OH)vitamin D3 levels did not differ between the healthy and the allergic groups. However, the β-CTx was lower in the H1Rantagonists treated allergic children (1090.82±80.25 pg/ml) in comparison with controls (1456.58±95.81 pg/ml; p=0.006). The β-CTx/OCN ratio was found to be lower in the H1R-antagonists treated allergic than in the controls (9.24±0.608 vs. 12.65±0.53; p=0.001). β-CTx serum level correlated with OCN in the controls (r=0.845, p<0.001) and in the H1R-antagonist treated allergic, too (r=0.519, p=0.005). Higher HDC expression and H1 receptor down regulation was found in allergic children. The CD3+/CD16-56+ T cells were in higher rate in children of control group. CONCLUSION - Decreased bone resorption was found among H1 receptor antagonist treated allergic children, which is indicated by serum markers. Therefore, bone turnover is shifted toward bone formation in the H1Rantagonist treated allergic subjects.]

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[Evaluation of quality of life following treatment with calcitonin nasal spray in patients with osteoporosis: preliminary results of the MERLIN study]

BORS Katalin, KÓSA József, BORBÉLY Judit, TABÁK Ádám, HORVÁTH CSABA

[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.]

Ca&Bone

[Bone metabolism and body mass index in postmenopausal women]

TÁRCZY Csaba, TOLDY Erzsébet, SZERB János, VARGA László

[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.]

Ca&Bone

[Bone mineral density and diabetes mellitus - First results]

TÕKE Judit, TAMÁS GYULA, STELLA Péter, NAGY Erzsébet, NÁDASDI Ágnes, VARGA Piroska, KERÉNYI ZSUZSA

[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.]

Lege Artis Medicinae

[THE IMPORTANCE OF ATTITUDES TO MEDICATION IN LIPID-LOWERING THERAPY PATIENT CO-OPERATION - PERSISTENCE AND COMPLIANCE]

NAGY László

[Controlled clinical studies on statins have produced evidence that the aggressive lowering of LDL-cholesterol (LDL-C) level reduces the mortality rate of ischaemic heart disease. About 40% of treated patients achieve the cholesterol target level. The observance of medication instructions on a daily basis (compliance) and willingness for long-term taking of the drug (persistence) are crucially important to avoid severe complications. In the long term, patients take only about 50% of their medicines according to the instructions. As a result of the generally poor compliance and persistence in taking the medications, the decrease in morbidity and mortality observed in clinical studies do not occur under real-life conditions. Patients with poor compliance (<80%) will experience only a minimal health benefit and the cost-effectiveness of the therapy will markedly decrease. For patients with poor persistence who discontinue their treatment before benefits at the clinical endpoints could manifest, the resources invested into the therapy will be lost. Both compliance and persistence deteriorate as the number of concurrently taken medicines increases. Since less than 50% of the programmes aimed at improving patient co-operation are successful, therapeutic decisions should preferably be made by taking into consideration the expected compliance/persistence already at the time of choosing the medication. By widening the use of fixed-dose combination therapies, the efficiency of treatment can substantially be increased in patients who concurrently take several medicines and require aggressive lowering of blood pressure or LDL-C level.]

LAM KID

[„HOPE for people with fracture”: Results of the HOPE (Hungarian Osteoporosis Project for Elderly) study]

SPEER Gábor, NÁDAS Katalin, FERENCZ VIKTÓRIA, MÉSZÁROS SZILVIA, HORVÁTH CSABA, BORS Katalin

[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. ]