Clinical efficacy and safety of use of alfacalcidol and calcitriol in daily endocrinological practice.

This paper aims to discuss and compare 2 vitamin D derivatives available on the Polish market, alfacalcidol and calcitriol, in the context of their effectiveness and safety in endocrine patients. Both above-mentioned substances find a number of applications, including in hypoparathyroidism, which is one of the most common indications for their use. We would also like to draw the reader's attention to the fact that there are quite a lot of reports in the literature on the positive effect of alfacalcidol and calcitriol on maintaining bone mass and the risk of fractures, which may bring additional potential benefits to our patients.

Effect of physical training on parathyroid hormone and bone turnover marker profile in relation to vitamin D supplementation in soccer players.

The aim of the study was to assess the impact of vitamin D supplementation and regular physical activity on 25-hydroxyvitamin D [25(OH)D], parathyroid hormone (PTH) and bone turnover marker concentrations in healthy male athletes. Twenty-five youth soccer players were divided into groups: non-supplemented (GN) and supplemented (GS) with a vitamin D dose of 20 000 IU twice a week for 8 weeks. The study was conducted during an 8-week preseason period, from mid-January to mid-March. At baseline (T1) and at the end of this period (T2), the serum concentrations of 25(OH)D, (PTH), osteocalcin (OC) and ß-isomerized C-terminal telopeptide of type I collagen (ß-CTx) were measured. At T2, 25(OH)D increased by 70% in GS (p = 0.004) and by 6% in GN (p > 0.05). Significant differences between GS and GN groups were observed throughout the study in the group-by-time interaction and changes of 25(OH)D (p = 0.002; η 2 p = 0.36) and OC (p = 0.008; η 2 p = 0.26). Increased OC (ES = 0.74; moderate) and ß-CTx (ES = 1.31, large) in GN athletes who had an optimal baseline vitamin D level (GO) were observed. In GN, at T2, ß-CTx positively correlated with PTH and OC (p = 0.007 and p = 0.002). In GS, ß-CTx positively correlated with OC at both time points (T1, p = 0.027 and T2, p = 0.037). A negative correlation between 25(OH)D and PTH was observed at T2 (p = 0.018). The obtained results suggest that the 20 000 IU vitamin D3 dose applied twice a week for 8 weeks is effective for vitamin D compensation and sufficient to maintain the correct PTH concentration, as revealed by changes in the bone marker concentrations. In conclusion, the results suggest that the applied vitamin D supplementation dose in athletes leads to intensive bone remodelling and has protective effects on bone under intensive physical effort.

Fracture risk in obesity: a narrative review.

While low body mass index (BMI) is a risk factor for fractures, the association between obesity and fracture risk is inconsistent and puzzling. Several studies reported higher fracture risk (FR), and others reported lower FR in obese populations. Our narrative review presents the overall incidence of fractures by anatomic locations in adult patients, geriatric populations, and in those after bariatric surgery. In conclusion, obesity should be considered as a fracture risk in adults, as well as falls and fractures in geriatric patients, in particular in those with sarcopenic obesity, and after bariatric surgery. The specific characteristics of fractures risk associated with obesity should be considered by physicians in the diagnostic and therapeutic work-up of obese patients. This review outlines the current literature on this topic and aims to guide physicians regarding proper decisions to prevent fractures in patients with obesity.

Assessment of Wnt pathway selected gene expression levels in peripheral blood mononuclear cells (PBMCs) of postmenopausal patients with low bone mass.

The purpose of the study was to assess the expression of selected genes of the Wnt pathway: APC, AXIN1, CTNNB1, DKK1, GSK3ß, KREMEN1, SFRP1, and WNT1 in peripheral blood mononuclear cells (PBMC) of patients, selected in consideration of their bone mineral density (BMD), and the occurrence of low-energy fractures. The study involved 45 postmenopausal women, divided into four groups, according to BMD and fracture history. Measurements of laboratory parameters and RNA expression in PBMC cells were carried out in material, collected once at the inclusion visit. The densitometric examination was performed on all participants. In the analysis of the relative expression levels (RELs) of the studied genes in the entire population, we observed an overexpression for SFRP1 in 100% of samples and WNT1. In addition, the REL of DKK1, APC, and GSK3ß genes were slightly elevated versus the calibrator. In contrast, CTNNB1 and AXIN1 presented with a slightly decreased RELs. Analysis did not show any significant differences among the groups in the relative gene expression levels (p < 0.05) of particular genes. However, we have observed quite numerous interesting correlations between the expression of the studied genes and BMD, the presence of fractures, and laboratory parameters, both in the whole studied population as well as in selected groups. In conclusion, the high level of CTNNB1 expression maintains normal BMD and/or protects against fractures. It also appears that the changes in expression levels of the Wnt pathway genes in PBMCs reflect the expected changes in bone tissue.

Evaluation of the relationship between the IL-17A gene expression level and regulatory miRNA-9 in relation to tumor progression in patients with non-small cell lung cancer: a pilot study.

A pro-inflammatory cytokine, IL-17A, is associated with increased risk of developing numerous cancers, including non-small cell lung cancer (NSCLC). IL-17A is a target gene for miR-9. This encouraged us to analyze these two genes in terms of their usefulness as prognostic markers in NSCLC. The expression levels of IL-17A gene and miR-9 was assessed in 26 NSCLC tissue samples and 26 unchanged lung tissue adjacent to lung tumors (control tissue), using qPCR. In both tissue groups, a decreased expression of IL-17A was observed in 100% of samples. Increased expression of miRNA-9 was observed in 92% of tumor samples, and in 100% of control samples. Neither statistical differences in the level of expression IL-17A depending on the patient's age, gender, smoking status, nor histopathology of the cancer was found. Regarding the presence of nodule metastasis ('N' value in TNM classification), significantly lower expression level of IL-17A was observed in cN2 as compared with cN1 group. Additionally, statistically lower IL-17A expression was found in III versus II tumor stage (cAJCC classification). Significant negative correlation between both studied genes was revealed in SCC subgroup. This leads to the conclusion that miRNA-9 can regulate the expression of IL-17A as an IL-17A mRNA antagonistic mediator. Inhibition of proinflammatory action of IL-17A in correlation with tumor progression can be related to various activity of Th17 cells on cancer development according to its immunogenicity, and also may suggest suppressive role of IL-17A in tumor progression. However, because of low number of analyzed samples, further studies on the functional role of IL-17A in development and/or progression NSCLC seem warranted.

The efficacy of pharmacotherapy in postmenopausal osteoporosis: a longitudinal observational study.

INTRODUCTION: The aim of the study was an assessment of longitudinal changes in fracture probability in postmenopausal women. MATERIAL AND METHODS: A group of 226 postmenopausal women at baseline mean age 66.46 ± 7.96 years were studied. There were 21 women without therapy, 102 taking calcium + vitamin D, and 103 women on antiresorptive therapy, in the study group. Data concerning clinical risk factors for osteoporosis and hip BMD were gathered. Fracture probability for major and hip fractures was established using FRAXTM. RESULTS: Mean follow-up time was 2.43 ± 0.59 years. Baseline FRAX value in the whole group for major fracture was 7.1 ± 4.18, and at follow-up it was 7.44 ± 4.04. Respective results for FRAX for hip fracture were 3.17 ± 2.69 and 3.02 ± 2.35. In the whole group the probability for major fractures significantly increased during follow-up (p < 0.05) and for hip fracture did not change. In non-treated patients and patients taking calcium + vitamin D the fracture probability increased significantly. In patients on antiresorptive therapy the fracture probability did not change, which was connected with an improvement in bone status assessed by DXA. Femoral neck T-score in the whole group did not change, in those not treated and taking calcium + vitamin D it decreased significantly (p < 0.05), while in treated women it increased significantly (p < 0.05). In patients with improved bone status the FRAX values for major and hip fractures decreased by 0.44 ± 1.62 and 0.36 ± 1.19, respectively. Conversely, in patients with worsening T-score value the FRAX values increased by 1.33 ± 1.42 and 0.66 ± 1.25, respectively. CONCLUSION: Antiresorptive therapy stabilises fracture probability in postmenopausal women due to improvement in bone status.

Effects of physical activity on sclerostin concentrations.

Osteoporosis is a serious medical and socioeconomic problem of the 21st century. Mechanical load is a key regulator which controls bone formation and remodelling, with participation of osteocytes. Sclerostin is produced and released by mature osteocytes into bone surface, where it inhibits the conveyance of osteoblast proliferation and differentiation activating signals from mesenchymal cells, thus suppressing new bone formation. The goal of the study was an evaluation of the effects of a 12-week physical training programme on the levels of bone turnover markers [Sclerostin, Osteocalcin (OC), C-terminal telopeptide of type I collagen (ß-CTX)] in blood serum of women with osteopenia. MATERIALS & METHODS: The study included 50 women of the Regional Menopause and Osteoporosis Centre of the WAM Teaching Hospital, at the age of 50-75 years with the diagnosis of osteopenia, obtained on the basis of hip and/or lumbar spine densitometry (T-score from -1.0 to -2.5 SD). During the initial 12 weeks (between point 1 and 2), the patients maintained their previous, normal level of physical activity. During subsequent 12 weeks (between point 2 and 3), a programme of exercise was implemented. The programme included the interval training on a bicycle ergometer, three times a week for 36 minutes. During the entire study duration, all the patients received a supplementation of calcium (500 mg) and vit. D3 (1800 IU) once daily. Serum levels of OC, alkaline phosphatase (ALP), ß-CTX and sclerostin were assayed at 3 time points. RESULTS: After the course of the exercise cycle, the OC concentration was increased, sclerostin levels decreased, while no statistical differences were observed in ß-CTX levels vs. the period of physical inactivity. No correlations were found between sclerostin level changes and osteocalcin level changes during the training time, because of too small groups. Neither statistically significant were the differences in alkaline phosphatase, calcium and phosphorus levels. CONCLUSIONS: The obtained results emphasise the role of physical training as an effective stimulation method of bone formation processes in women with osteopenia. Sclerostin can be a marker of physical activity. < /p > < p >.

Evaluation of vitamin D concentration in a population of young, healthy women - the effects of vitamin D supplementation.

INTRODUCTION: The goal of the study was an evaluation of serum vitamin D concentrations in healthy young women. MATERIAL AND METHODS: A total of 106 healthy women, aged 20-30 years, were included in the study. Monthly evaluation - for three months - of the effects of calcium (500 mg) and vitamin D (1500 IU) administration in women with baseline values of vitamin D < 20 ng/mL (Group 1) plus the effects of an 800 IU/d dose in women with the baseline value of D > 20 ng/mL (Group 2). Additionally, calcium and PTH concentrations were assessed at the study onset and after a three-month supplementation. Only 67 women adhered to the prescribed therapeutic regime during the three months of observation. RESULTS: The mean vitamin D concentration in the entire study group was 16.56 ng/mL, being 12.6 ng/mL in Group 1 and 25.22 ng/mL in Group 2. In the course of vitamin D administration, its concentration increased statistically significantly, both in the entire group and in the subgroups, at all time points compared with the study onset. Moreover, its concentration in the whole population and in Group 1 was significantly higher in each of the time points not only in relation to the baseline, but also in comparison with the results of the previous measurements (after 1 and 2 months of supplementation). In Group 2, vitamin D levels also increased systematically throughout the whole study period, and after 3 months its concentration was significantly higher than after 1 and 2 months. Although there were no differences in calcium concentration after those three months, a statistically significant drop of PTH (p < 0.05) was recorded in the entire population and in Group 1. CONCLUSIONS: A moderate deficiency of vitamin D was observed in the studied population of young women. A supplementation with calcium plus vitamin D brought about an increase of vitamin D concentration as early as in the first month of administration. The optimal concentration of > 30 ng/mL was achieved in Group 1 after three months of vitamin D administration in 1500 IU/d dose.

The role of selenium in thyroid gland pathophysiology.

It is now assumed that proper functioning of the thyroid gland (TG), beside iodine, requires also a number of elements, including selenium, iron, zinc, copper, and calcium. In many cases, only an adequate supply of one of these microelements (e.g. iodine) may reveal symptoms resulting from deficits of other microelements (e.g. iron or selenium). Selenium is accounted to the trace elements of key importance for homeostasis of the human system, in particular, for the proper functioning of the immune system and the TG. Results of epidemiological studies have demonstrated that selenium deficit may affect as many as one billion people in many countries all over the world. A proper sequence of particular supplementations is also worth emphasising for the significant correlations among the supplemented microelements. For example, it has been demonstrated that an excessive supplementation of selenium may enhance the effects of iodine deficit in endemic regions, while proper supplementation of selenium in studied animals may alleviate the consequences of iodine excess, preventing destructive-inflammatory lesions in the TG. This paper is a summary of the current knowledge on the role of selenium in the functionality of the TG.

Correlations between 10-year risk of death from cardiovascular diseases.

INTRODUCTION: Osteoporosis and cardiovascular diseases (CVD) are more common in the elderly population and have similar risk factors. THE GOAL: was an evaluation of the correlation between 10-year risk of death from CVD and 10-year bone fracture risk (FRAX). MATERIAL AND METHODS: A total of 79 patients of the Regional Centre of Menopause and Osteoporosis of the Military Teaching Hospital in Lodz (Poland), aged 50-83 years, consulted for osteoporosis were divided into two groups: study group - with osteoporosis (O; T-score ≤ -2.5 SD) and control - without osteoporosis (T-sc > -2.5). Bone mineral density was evaluated by densitometric scanning of spine (L2-L4 T-score) and/or femoral neck (Neck T-score) and/or total hip (Total Hip T-score). Total cholesterol (TC), fasting glucose, arterial blood pressure, medical history, and family history were obtained. The risk of fatal-CVD was assessed by Euro Heart Score (EHS), and major osteoporotic (MOFR) and hip fracture risk (HFR) by the FRAX scale. RESULTS: 80% of the patients (32/40) with osteoporosis and 51% (20/39) of the patients without osteoporosis revealed a HeartScore ≥ 5%. There was correlation in the group of all patients between EHS and Neck T-score (p < 0.05; Spearman rank correlation coefficient (Rs) = -0.3806), L2-L4 T-score (p < 0.05; Rs = -0.2891), and Total Hip T-score (p < 0.005; Rs = -0.3561), and in the control group - between EHS and Neck T-score (p < 0.05; Rs = -0.3502). There was a 2.33% difference between the average EHS level to the disadvantage of patients with osteoporosis (p < 0.05). EHS positively correlated with MOFR (p < 0.001) and HFR (p < 0.001) in the whole study popula-tion and with MOFR (p < 0.05) and HFR (p < 0.01) in the group of osteoporotic patients. There were differences between groups in TC (p < 0.001) and BMI (p < 0.001) levels. CONCLUSIONS: The 10-year risk of fatal-CVD correlated with osteoporosis and with the 10-year osteoporotic fracture risk. This conclusion may help identify patients who require extended cardiotherapy protocols.

Assessment of OPG, RANKL, bone turnover markers serum levels and BMD after treatment with strontium ranelate and ibandronate in patients with postmenopausal osteoporosis.

INTRODUCTION: The aim of this study was to evaluate quantitative changes in OPG and RANKL proteins after treatment with strontium ranelate (SR) and ibandronate in patients with postmenopausal osteoporosis. MATERIAL AND METHODS: A total of 89 women with postmenopausal osteoporosis (PO), aged 51-85 years, patients of the Outpatient Clinic of Osteoporosis of the Military Teaching Hospital in Lodz, were enrolled in the study. The patients were randomly assigned to different therapies: ibandronate and (SR). Patients of the control group received only calcium and vitamin D3 supplements. The patients' visits were repeated after three and six months. Measurements of beta-CTX (C-terminal Telopeptide of type 1 collagen), osteocalcin, RANKL, osteoprotegerin (OPG), alkaline phosphatase concentrations in serum, as well as of total 24-hour calcium and phosphate levels in serum and urine, were carried out in material collected at baseline and after three and six months of therapy. Left hip and lumbar spine densitometry was done twice (at baseline visit and after six months). RESULTS: In all three groups there were no significant differences noted in the concentrations of OPG and RANKL serum protein levels during the study period. Both negative and positive correlations or tendencies of correlations were found between OPG serum concentrations and BMD changes in the SR group. CONCLUSIONS: Both ibandronate and SR do not seem to cause any significant changes in OPG and RANKL protein serum levels during the first six months of treatment. OPG may play a role in osteoclast activity suppression in the course of treatment with ibandronate in patients with PO. OPG may play an important role in the mechanism of SR therapy and may be viewed as a potentially valuable parameter for monitoring and predicting the course of treatment with SR in PO.

FRAX calculator and Garvan nomogram in male osteoporotic population.

PURPOSE: The aim of the study was the presentation of osteoporotic fracture prediction in men. METHODS: Eight-hundred and one men at the mean age of 70.8 ± 9.31 years were examined. The 10-year fracture prediction was established, using the FRAX calculator and Garvan nomogram. RESULTS: The mean value for any fracture and hip fracture probabilities for FRAX were 7.26 ± 5.4% and 3.68 ± 4.25%, respectively. For Garvan fracture, risk values were 26.44 ± 23.83% and 12.02 ± 18.1%. The mean conformity for any fracture and hip fracture prediction for threshold of 20% (any fracture) and 3% (hip fracture) between Garvan and FRAX values was 55.8% (κ 0.041) and 79.65% (κ 0.599), respectively. ROC analyses showed the following areas under the ROC curves (AUC) for any fractures: FRAX 0.808 and Garvan nomogram 0.843 (p = 0.059). The AUC values for hip fractures were 0.748 for Garvan nomogram and for 0.749 FRAX, and did not differ. On the base of ROC data, the cut-off values with best accuracy to predict fractures for both methods were established. The conformity between methods for thresholds indicated by ROC analysis was 72.5% (κ 0.435) for any and 77.7% (κ 0.543) for hip fractures. CONCLUSION: The conformities between FRAX and Garvan in regard to hip fracture prediction were acceptable for a threshold of 3% and thresholds derived by ROC analysis, while for any fracture we recommend to use thresholds established by ROC analysis. This may suggest that the use of "universal" cut-off points is probably misleading.

The role of counselling and other factors in compliance of postmenopausal osteoporotic patients to alendronate 70 therapy.

INTRODUCTION: The aim of the study was to assess the role of patient counselling, nurse assistance and effects of biochemical examinations in adherence of women with postmenopausal osteoporosis to alendronate 70 administration over 12 months of therapy. MATERIAL AND METHODS: Compliance and persistence to alendronate 70 therapy were assessed in a prospective study of 123 postmenopausal women, followed up for one year. The patients were divided into 4 groups (controls, counselled group, biochemical group and nurse assisted group) with monitoring every 6 months; in the nurse assisted group, additional phone contacts were made after 3 and 9 months of treatment. After 12 months, compliance and persistence were analysed. The medication possession ratio (MPR) was regarded as optimal when its value exceeded 80%. RESULTS: The compliance to alendronate 70 therapy was 54.03% in the control group and the mean persistence with medication was 197 days. The MPR above 80% was observed in 37.5%, and, after 1 year, 43.75% of patients were found persistent with the therapy. In the remaining groups, both compliance and persistence were higher but not statistically significantly, compared to the control group. Neither patient's age, education, diet, nor physical activity influenced the compliance with prescribed therapy. The most common reason to discontinue therapy was either its side effects or smoking. CONCLUSIONS: The obtained results suggest that better adherence with medical recommendations is observed in patients who receive additional attention, e.g. counselling, biochemical tests or nursing care. The critical elements for therapy discontinuation were side effects and smoking.

Assessment of OPG/RANK/RANKL gene expression levels in peripheral blood mononuclear cells (PBMC) after treatment with strontium ranelate and ibandronate in patients with postmenopausal osteoporosis.

CONTEXT: Recent research results have confirmed the high significance of the OPG/RANK/RANKL system in the development of bone diseases. AIM: The aim of the reported study was to assess gene expression levels of the OPG/RANK/RANKL system in peripheral blood mononuclear cells (PBMCs) after strontium ranelate (SR) and ibandronate administered to patients with postmenopausal osteoporosis. PATIENTS AND METHODS: A total of 89 postmenopausal women, aged 51 to 85 years, patients of the Outpatient Clinic of Osteoporosis of the Military Teaching Hospital in Lodz, were enrolled into the study. The patients were randomly assigned to different medical therapies: ibandronate and SR. Patients of the control group received only calcium and vitamin D3 supplements. Patient visits were repeated after 3 and 6 months. Measurements of serum alkaline phosphatase concentrations and of RNA expression in PBMCs as well as of total serum calcium and phosphate levels and of their 24-hour urine excretion rates were carried out in material, collected at baseline and after 3 and 6 months of the therapy. Densitometry of the left hip and of the lumbar spine was done at the baseline visit and after 6 months. RESULTS: The differences in gene expressions of RANKL and RANK were not significant during the study period and did not differ between the groups in a statistically significant manner. No OPG gene expression was observed in PBMCs of patients in any of the studied groups and at any time point. The tendency of correlation (P = .07) was observed between decreasing RANK gene expression and increasing bone mineral density in the patients treated with SR. CONCLUSIONS: Both ibandronate and SR do not seem to cause any significant changes in gene expression levels of OPG/RANK/RANKL in PBMCs during the first 6 months of treatment.

[Bisphosphonates and the risk of atrial fibrillation]. / Bisfosfoniany a ryzyko migotania przedsionków.

Osteoporosis is a growing problem in an ageing society. It affects women of post-menopausal age, as well as elderly subjects of both sexes, often with dysfunction of the cardiovascular system or with an increased risk of circulation disorders. It has been found that the mortality rate of subjects with osteoporosis is comparable to that of patients suffering from such diseases as obturative pulmonary disease or myocardial ischaemia. Bisphosphonates are the most thoroughly studied group of drugs prescribed for the treatment of osteoporosis. Their administration is, however, associated with a risk of adverse symptoms, which can occur as gastro-intestinal tract disturbances, muscular-osseous pains, mandible necrosis, atypical fractures and other symptoms. Recently, there has been discussion about an increased risk of atrial fibrillation in bisphosphonate-using female patients. This paper focuses on this particular problem, while summing up the actual status of knowledge regarding possible associations of bisphosphonates with cardiac rhythm disturbances.

[The role of i.v. ibandronate administration in osteoporosis therapy]. / Rola dozylnej postaci ibandronianu w terapii osteoporozy.

Osteoporosis is a chronic disease of the osseous system characterised by decreased strength of bone tissue, which in turn leads to increased fracture risk. It has been demonstrated that osteoporosis affects more than 30% of women after the menopause (World Health Organization, 1994). However, the disease is also observed in men. The primary goals of osteoporosis therapy include prevention of low-energy fractures and general improvement of quality of life. Any patient with diagnosed osteoporosis requires, besides prevention, the application of proper treatment. Of the available therapeutic options, the best are bisphosphonates, medical agents with well identified properties, therapeutic efficacy, and safety which has been confirmed in many clinical studies. Therefore, they are recommended as first line drugs for osteoporosis. The efficacy of oral preparations may be limited, due to low bioavailability, complications and adverse effects from the gastrointestinal tract. So the parenteral administration of bisphosphonates is a valuable alternative. A fine example of such therapy is the intravenous administration of ibandronate. Short injection time periods and the relatively long, three-month intervals between administrations are unquestionable advantages of this therapy mode. In addition, the therapy does not constrain a patient's everyday activity, and simultaneously provides regular contact with doctors and the therapeutic centre. Additionally, a good tolerance of the drug and its high therapeutic efficacy, proven by appreciably reduced fracture risks, significantly improves the quality of life of patients suffering from osteoporosis. This paper is a thorough review of current knowledge on the efficacy and safety of i.v. ibandronate in osteoporosis therapy, as presented in the latest literature reports.

Transplantation osteoporosis.

Transplantation provides a valuable, often life-saving, treatment for end-stage failure of many organs, including the heart, kidneys, liver, pancreas and lungs. It is also an important therapeutic option in diseases of the bone marrow and the immune system. Despite the undoubted benefits for transplant patients, it is associated with an increased risk of many complications. The potential causes include: poor general health of the patient, heavy burden of the surgery itself and the need for the long-term use of immunosuppression. In addition, the patients are also on numerous other medications, e.g. anti-coagulants, diuretics. Osteoporosis and high risk of fractures have emerged as frequent and devastating complications of the transplantation process. This article provides a review of the current literature on osteoporosis after transplantation, and the treatment options for this serious illness.

Bisphosphonates and the risk of atrial fibrillation.

Osteoporosis is a growing problem in an ageing society. It affects women of post-menopausal age, as well as elderly subjects of both sexes, often with dysfunction of the cardiovascular system or with an increased risk of circulation disorders. It has been found that the mortality rate of subjects with osteoporosis is comparable to that of patients suffering from such diseases as obturative pulmonary disease or myocardial ischaemia. Bisphosphonates are the most thoroughly studied group of drugs prescribed for the treatment of osteoporosis. Their administration is, however, associated with a risk of adverse symptoms, which can occur as gastro-intestinal tract disturbances, muscular-osseous pains, mandible necrosis, atypical fractures and other symptoms. Recently, there has been discussion about an increased risk of atrial fibrillation in bisphosphonate-using female patients. This paper focuses on this particular problem, while summing up the actual status of knowledge regarding possible associations of bisphosphonates with cardiac rhythm disturbances.

Alendronate 70 therapy in elderly women with post-menopausal osteoporosis: the problem of compliance.

INTRODUCTION: More than half of those with chronic diseases, including osteoporosis, discontinue treatment during the first year of its administration. This problem increases over the course of continued follow-up. Additionally, it has been observed that 13% of women, prescribed oral daily alendronate, do not even start the treatment, while 20% of patients discontinue the therapy during the first four months. On the other hand, those patients who are compliant achieve increased bone mass density with a simultaneous decrease of fracture risk. The aim of our study was to assess the adherence to the recommended alendronate 70 administration protocol over the course of 12 months by women with post-menopausal osteoporosis. MATERIAL AND METHODS: Adherence (compliance plus persistence) to alendronate 70 therapy was assessed in a prospective study of 153 post-menopausal women, followed up for one year with monitoring every two months. RESULTS: Adherence to therapy of all the study participants was high during the entire study period, the patients remaining compliant after a year in 95.08 ± 1.39% (mean ± SEM) of cases, and the mean persistence with medication was 347.05 ± 5.07 days. In the group of patients who interrupted treatment, the mean persistence was 212.44 days. One of the study participants did not start the treatment, and another two discontinued the therapy within 30-60 days of the study onset (between the first two visits). Facilitated contacts with the doctor, continuous access to prescribed treatment and frequent visits significantly improved patient compliance. The common reason for discontinuation was side effects, while age (but not education) affected the rate of compliance with therapy. The worst results were obtained in the group of patients with osteoporosis diagnosed more than five years before the study, particularly in the subgroup where alendronate was being used for the first time or where treatment resumed after a substantial break. CONCLUSIONS: The obtained results indicate that better adherence to alendronate 70 therapy, administered once a week, depends on more frequent monitoring of treated patients.

The role of i.v. ibandronate administration in osteoporosis therapy.

Osteoporosis is a chronic disease of the osseous system characterised by decreased strength of bone tissue, which in turn leads to increased fracture risk. It has been demonstrated that osteoporosis affects more than 30% of women after the menopause (WHO, 1994). However, the disease is also observed in men. The primary goals of osteoporosis therapy include prevention of low-energy fractures and general improvement of quality of life. Any patient with diagnosed osteoporosis requires, besides prevention, the application of proper treatment. Of the available therapeutic options, the best are bisphosphonates, medical agents with well identified properties, therapeutic efficacy, and safety which has been confirmed in many clinical studies. Therefore, they are recommended as first line drugs for osteoporosis. The efficacy of oral preparations may be limited, due to low bioavailability, complications and adverse effects from the gastrointestinal tract. So the parenteral administration of bisphosphonates is a valuable alternative. A fine example of such therapy is the intravenous administration of ibandronate. Short injection time periods and the relatively long, three-month intervals between administrations are unquestionable advantages of this therapy mode. In addition, the therapy does not constrain a patient's everyday activity, and simultaneously provides regular contact with doctors and the therapeutic centre. Additionally, a good tolerance of the drug and its high therapeutic efficacy, proven by appreciably reduced fracture risks, significantly improves the quality of life of patients suffering from osteoporosis. This paper is a thorough review of current knowledge on the efficacy and safety of i.v. ibandronate in osteoporosis therapy, as presented in the latest literature reports.