[„HOPE for people with fracture”: Results of the HOPE (Hungarian Osteoporosis Project for Elderly) study]
SPEER Gábor1, NÁDAS Katalin2, FERENCZ VIKTÓRIA3, MÉSZÁROS SZILVIA3, HORVÁTH CSABA3, BORS Katalin4
MARCH 30, 2014
LAM KID - 2014;4(01)
SPEER Gábor1, NÁDAS Katalin2, FERENCZ VIKTÓRIA3, MÉSZÁROS SZILVIA3, HORVÁTH CSABA3, BORS Katalin4
MARCH 30, 2014
LAM KID - 2014;4(01)
[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. ]
[The physiological role of vitamin K in blood clotting and bone metabolism is well known. A number of articles have been published recently about the effects of vitamin K2 on bone. Non-professional media promotes vitamin K2 as a potent tool for the prevention and treatment of osteoporosis. Nevertheless vitamin K2 is not included in either Hungarian, or European, or American guidelines as an anti-osteoporotic medication. Our aim was to review the literature and provide a systematic review on the role of vitamin K2 in the prevention and treatment of osteoporosis. We have searched articles on http://pubmed.org available on 14. February 2014. Our search terms were: („vitamin K2” OR „menaquinon” OR „MK-7” OR „menantrenon”) AND „osteoporosis”. We have only reviewed original articles that discussed the relationship of vitamin K2 and osteoporosis, and had at least the abstract available in English. Of the 155 articles found, 135 had a relevant topic, 126 had at least the abstract in English. Of these, 73 were original articles, including 44 human studies (8 double-blind, controlled, 26 open-label, controlled, 5 observational and 5 cross-sectional studies) and 29 animal or in vitro models. In the non-Asian population there is no evidence for fracture-preventing or BMD-increasing effect of vitamin K2 treatment. The currently recommended anti-osteoporotic medications are significantly more efficient compared with the BMD increase observed in some Asian studies. ]
[The Hungarian EFEZUS study (Estimation oF the Effectiveness of Zoledronic acid in Use in Steroid-induced osteoporosis in real life) was a multicentre, prospective, non-interventional, open-label, one-year-long study, in which we assessed the effect of zoledronic acid on bone mineral density and on the markers of bone turnover in osteoporosis developing after treatment with glucocorticoids. The mean baseline lumbar BMD was 0.762 g/cm2 and by the end of 12 month it increased to 0.818 g/cm2 (p<0.0001). The mean BMD measured at the femoral neck during visit 1 was 0.675 g/cm2, and it increased to 0.711 g/cm2 by visit 2 (end of study) (p<0.0005). The levels of bone turnover markers (cTX, nTX) significantly decreased between visits 1 and 2 (p<0.05). The mean cTX level at visit 1 was 421.2 ng/l (SD: 309 ng/l), which decreased to 253.3 ng/l (SD: 188.1 ng/l) by visit 2. The mean change in the levels of nTX was 0.65 µg/l (SD: 0.36 µg/l) and 0.39 µg/l (SD: 0.28 µg/l), respectively. There was no major change in serum and urine calcium levels. Five adverse events were reported by 4 patients during the study. ]
[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.]
Hypertension and nephrology
[The primary aim of cardiovascular prevention is to reach adequate blood pressure control. To prevent the development of target organ lesion it is essential to use long-acting, well tolerable drugs without significant side effects. Angiotensin-converting enzyme (ACE) inhibitors are popular and excellent preparations but their side effects reduce life long patient compliance. Angiotensin II receptor blockers (ARBs) are effective drugs having unique tolerability and a capability to reduce cardiovascular morbidity and mortality to the same extent as the ACE inhibitors. Especially high risk patients benefit from their combination with thiazide diuretics or with calcium channel blockers. Clinical trials proved that telmisartan can be safely given and well tolerable alone or in combination to high risk cardiovascular patients, in heart and renal, peripheral vascular and cerebrovascular diseases combined or not with diabetes.]
[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.]
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