LAM KID

[Does the vitamin K2 play a role in the prevention or treatment of osteoporosis? - a systematic review]

SZILI Balázs, TAKÁCS István

MARCH 30, 2014

LAM KID - 2014;4(01)

[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. ]

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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

[The EFEZUS study: Estimation oF the Effectiveness of Zoledronic acid in Use in Steroid-induced osteoporosis in real life]

KISS Csaba György, SURMANN Ágnes, DRESCHER Edit

[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. ]

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Management of bone metabolism in epilepsy

UÇAN TOKUÇ Ezgi Firdevs , FATMA Genç, ABIDIN Erdal, YASEMIN Biçer Gömceli

Many systemic problems arise due to the side effects of antiepileptic drugs (AEDs) used in epilepsy patients. Among these adverse effects are low bone mineral density and increased fracture risk due to long-term AED use. Although various studies have supported this association with increased risk in recent years, the length of this process has not been precisely defined and there is no clear consensus on bone density scanning, intervals of screening, and the subject of calcium and vitamin D supplementation. In this study, in accordance with the most current recommendations, our applications and data, including the detection of possible bone mineralization disorders, treatment methods, and recommendations to prevent bone mineralization disorders, were evaluated in epilepsy patients who were followed up at our outpatient clinic. It was aimed to draw attention to the significance of management of bone metabolism carried out with appropriate protocols. Epilepsy patients were followed up at the Antalya Training and Research Hospital Department of Neurology, Epilepsy Outpatient Clinic who were at high risk for osteoporosis (use of valproic acid [VPA] and enzyme-inducing drugs, using any AED for over 5 years, and postmenopausal women) and were evaluated using a screening protocol. According to this protocol, a total of 190 patients suspected of osteoporosis risk were retrospectively evaluated. Four patients were excluded from the study due to secondary osteoporosis. Of the 186 patients who were included in the study, 97 (52.2%) were women and 89 (47.8%) were men. Prevalence of low bone mineral density (BMD) was 42%, in which osteoporosis was detected in 11.8% and osteopenia in 30.6% of the patients. Osteoporosis rate was higher at the young age group (18-45) and this difference was statistically significant (p=0.018). There was no significant difference between male and female sexes according to osteoporosis and osteopenia rates. Patients receiving polytherapy had higher osteoporosis rate and lower BMD compared to patients receiving monotherapy. Comparison of separate drug groups according to osteoporosis rate revealed that osteoporosis rate was highest in patient groups using VPA+ carbamazepine (CBZ) (29.4%) and VPA polytherapy (19.4%). Total of osteopenia and osteoporosis, or low BMD, was highest in VPA polytherapy (VPA+ non-enzyme-inducing AED [NEID]) and CBZ polytherapy (CBZ+NEID) groups, with rates of 58.3% and 55.1%, respectively. In addition, there was no significant difference between drug groups according to bone metabolism markers, vitamin D levels, and osteopenia-osteoporosis rates. Assuming bone health will be affected at an early age in epilepsy patients, providing lifestyle and diet recommendations, avoiding polytherapy including VPA and CBZ when possible, and evaluating bone metabolism at regular intervals are actions that should be applied in routine practice.

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. ]