Ca&Bone

[Overcome of bisphosphonate resistance with alphacalcidol: results of a one year, open follow-up study]

GAÁL János, BENDER Tamás, VARGA József, HORVÁTH Irén, KISS Judit, SOMOGYI Péter, SURÁNYI Péter

DECEMBER 28, 2009

Ca&Bone - 2009;12(03)

[INTRODUCTION - A considerable part of osteoporotic patients do not respond satisfactorily to adequate treatment with a bisphosphonate plus supplementation with calcium and conventional vitamin D3. This study intended to determine whether the replacement of vitamin D3 with alphacalcidol results in any BMD increase, i.e. is it possible to overcome resistance to bisphosphonates. PATIENTS AND METHOD - In 76 patients unresponsive to the combination of alendronate and conventional vitamin D3, the latter had been replaced with alphacalcidol (0.5 μg/day), and then the patients were followed up for a year. Clinical and laboratory parameters were recorded at baseline and after one year of treatment; and their changes were analysed by statistical methods. RESULTS - After treatment for one year, Wilcoxon test revealed a small but statistically significant (p<0.001) increase in the BMD values of the forearm (+2.2%) and lumbar vertebrae (+1.4%). At the end of the treatment period, the following, significant changes were observed compared to baseline (median values): serum calcium level increased by 0,06 mmol/l; serum phosphorus level decreased by 0.05 mmol/l, serum alkaline phosphatase activity decreased by 13 U/l, and urinary calcium/creatinine ratio in first-voided morning urine increased by 0.1. Additionally, serum PTH level decreased by 10.7 pg/ml (median). Serum levels of osteocalcin decreased by 0.4 ng/ml, along with the urinary D-Pyr /kreatinine ratio by 0.2 nmol/mmol (median). No significant increase of adverse events occurred. DISCUSSION - As suggested by our results, combination therapy with alendronate and alfacalcidol increases bone density and improves the biochemical markers of bone turnover - without any substantial increase in the incidence of adverse effects.]

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[Vitamin D in autoimmun disorders: the immunregulatory effect of vitamin D and therapeutic opportunities]

ZÖLD Éva, SZODORAY Péter, GAÁL János, SZEGEDI Andrea, SZEGEDI Gyula, BODOLAY Edit

[There is recent evidence that genetic and environmental factors play an important role in the development of autoimmune diseases. Vitamin D deficiency is one of the environmental factors that may play a role in developing autoimmune diseases. Low vitamin D status has been implicated in the etiology of autoimmune diseases such as multiple sclerosis, systemic lupus erythematosus, rheumatoid arthritis, inzulin dependent diabetes mellitus, and inflammatory bowel disease. Experimentally, vitamin D deficiency results in an increased incidence of autoimmune disease. The authors discuss the accumulating evidence pointing to a link between vitamin D and autoimmunity. The optimal level of vitamin D intake is necessary to normalize the immune functions and it plays an important role in the development of self-tolerance. Targets for vitamin D in the immune system have been identified and the mechanism of vitamin D mediated immunoregulation is beginning to be understood. On the basic of recent knowledge, vitamin D causes a decrease in Th1-driven autoimmune response and repairs the function of regulatory T cells. Increased vitamin D intakes might decrease the incidence and severity of autoimmune diseases.]

Ca&Bone

[Hip fractures in Hungary between 2001 and 2008 - Assessment of the beneficial effect of bisphosphonates on the risk of hip fractures on the basis of Hungarian data]

HÉJJ Gábor

[The overall prevalence of osteoporosis in developed countries is estimated to be 9-15%. Mortality in the first year after the fracture is 15-20%, and half of the survivors remain partly or fully dependent on others’ support. Owing to the increasing life expectance and the diseases of civilisation, the incidence of osteoporotic fractures is expected to double in the next thirty years. The network of centers that has been developed since 1995 under the National Osteoporosis Program and the accreditation system of the National Osteoporosis Center provided up-to-date education of the physicians (densitometry assistants) who work within the network. The diagnostic restrictions followed by the reduction of support to 70% since 2006 fall resulted in a dramatic reduction in the number of treated patients.]

Ca&Bone

[Modelling of burden of femoral neck fracture from purchaser’s point of view]

SEBESTYÉN Andor, PÉNTEK Márta, GULÁCSI László, NYÁRÁDY József

[OBJECTIVE - This study provides a model of the treatment cost of femoral neck fracture and financial burden of the annual fracture cases at 2009 financial level from health insurance point of view. METHOD - The costs of the treatment of femoral neck fractures are modelled according to the actually OEP reimbursed types of care including acute inpatient care, chronic inpatient care, outpatient care, pharmaceuticals and medical devices, home care (nursing), cost of travelling or transport and the disability to work. Cases healing following primary treatment (without complications) and cases with complications are examined separately. The costs of most common complications with large surgical operation are calculated. RESULTS - The cost of patients in active age-groups cured by primary treatment can vary in a range of 1.010.110- 1.479.034 HUF depending on cost level of individual care and utilization, while the cost of patients in retired agegroups (pensioners) can vary in a range 635.350- 1.104.274 HUF. The cost of patients with complication (primary treatment and complication) in active agegroups can reach. 1 858.438-3.133.096 HUF depending on cost level of individual care and utilization, while the cost of patients in retired age-groups (pensioners) can reach 1.108.918-2.383.576 HUF. According to our model calculations, the cost of primary treatment of femoral neck fractures and essential further treatment represents an annual burden of 4.373.857.668-6.247.717.438 HUF for the health insurance system. CONCLUSION - In order to reduce the incidence of hip fractures one should emphasize the importance of current and future interventions, which projects the possibility of reducing the financial burden at societal level. The analysis of financial burden could serve as a base for health-economics studies, by elaborating a cost-effective strategy supported by professional and political decision makers.]

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Ca&Bone

[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.]

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. ]

LAM KID

[Once again on adherence - Is it just fashionable or indeed a timely issue?]

VALKUSZ Zsuzsanna

[Nonadherence to pharmacological treat-ment in osteoporosis is a well-recognised problem not only in Hungary but all over the world. As in other chronic diseases, adherence to osteoporosis treatment is poor, which results in serious problems affecting patients as well as health care resources. Low adherence rates consistent-ly result in increased rates of fractures. Some approaches aimed to improve com-plience and persistence, such as extension of dosing intervals, might improve patients’ adherence to therapy. International clinical studies have demonstrated that the number of fractures cannot be reduced without suf-ficient adherence. Improving patient edu-cation, enhancing interactions between health care providers and patients, taking into account patients’ preferences and involving them in treatment decisions may all improve adherence.]