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.

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.

Vitamin D receptor gene polymorphisms, bone mineral density and fractures in postmenopausal women with osteoporosis.

The goal of the study was to investigate the possibility of an association between polymorphisms and single alleles of BsmI, ApaI, TaqI of the vitamin D receptor (VDR) gene with bone mineral density (BMD) and prevalence of vertebral/non-vertebral fractures in a group of postmenopausal Polish women with osteoporosis. The study group comprised of 501 postmenopausal females with osteoporosis (mean age 66.4 ± 8.9), who were diagnosed on the basis of either the WHO criteria or self-reported history of low-energy fractures. The three polymorphisms were determined by PCR (polymerase chain reaction) and RFLP (restriction fragment length polymorphism). BMD at the lumbar spine and femoral neck was assessed by dual energy X-ray absorptiometry (DXA). 285 fractures were reported in the whole group (168 vertebral and 117 non-vertebral). Incidence of non-vertebral fractures was significantly higher in the carriers of single alleles a of ApaI, b of BsmI and T of TaqI VDR gene polymorphisms (p = 0.021, 0.032, 0.020, respectively). No significant associations between allelic variants of the studied polymorphisms and BMD or fracture incidence were found. (1).The presence of single alleles a,b and T of ApaI, BsmI, TaqI VDR gene polymorphisms respectively, might serve as an indicator of non-vertebral fractures. (2). Lack of association between the VDR gene polymorphisms and BMD suggests that VDR contributes to low-energy fractures also through other ways.

Prevalence of low serum vitamin D concentration in an urban population of elderly women in Poland.

INTRODUCTION: So far only scarce data have been published regarding serum vitamin D concentrations in elderly women in Poland. OBJECTIVES: We aimed to assess prevalence of vitamin D deficiency in a population of women aged 60 to 90 years and living in Warsaw. PATIENTS AND METHODS: The study comprised 274 women from the general population (mean age 69.1 -/+5.7 years, body mass index [BMI] 28.9 -/+4.6 kg/m2, serum creatinine concentration 0.7 -/+0.12 mg/dl). Subjects who had been treated with glucocorticoids or antifracture drugs, or supplemented with vitamin D or calcium, were excluded. The study was conducted in winter. Serum vitamin D, calcium, phosphate, and parathyroid hormone (PTH) concentrations were measured. RESULTS: The mean vitamin D concentration was 13.6 ng/ml in the whole examined population. Vitamin D levels above 30 ng/ml were detected in 4% of subjects. Vitamin D insufficiency (20-30 ng/ml) was found in 12.8% of subjects, and its deficiency (<20 ng/ml) in 83.2% of subjects. Vitamin D concentrations in women under and over 70 years of age did not differ significantly. There were no associations of vitamin D concentrations with age, BMI, renal function, or serum calcium concentrations. However, we observed a significant inverse correlation between vitamin D concentrations and PTH. CONCLUSIONS: The prevalence of low vitamin D concentrations in an urban population of elderly women in Poland is very high. Lower vitamin D levels are associated with a higher PTH concentration.

[Senile osteoporosis]. / Osteoporoza starcza.

The presented paper aims to summarize knowledge regarding senile osteoporosis. The article highlights high prevalence of the disease and the burden caused by osteoporotic fractures on the healthcare system. It describes shortly a complex ethiopathogenesis, in which vitamin D deficiency, other hormonal disturbances, protein-energy malnutrition, dysfunction of neuromuscular system and other factors may play a role. Possible diagnostics (x-rays, dual x-ray absorptiometry, 10-years fracture risk) and therapeutic methods are also presented.

[The histopathological evaluation of the local tolerance of alendronate containing medicines]. / Ocena histopathologiczna tolerancji miejscowej preparatów zawierajacych alendronian.

INTRODUCTION: In order to be effective, treatment for osteoporosis must be long-term. Unfortunately, according to clinical trials and clinical practice the most frequent cause of patient resignation from the treatment is adverse reactions to the medications. In the case of bisphosphonates they are most frequently connected with irritant impact of the drug on gastrointestinal mucosa. The aim of our study was to answer the question whether alendronate tablets coated with a thin neutral layer may protect gastrointestinal mucosa from the irritant effects of the active substance. MATERIAL AND METHODS: Three types of tablets were administered into the cheek pouches of 18 Syrian hamsters (divided into 3 experimental groups: I, II, III) i.e. regular alendronate tablets, coated alendronate tablets and placebo. The tablets were applied for 4 minutes a day on 4 consecutive days. 24 hours after the last application, the animals were sacrificed and segments of buccal tissue were taken for histopathological examination. Oral tissue reaction was assessed using the microscopic examination grading system developed by ISO. The following adverse changes of the tissue were recorded: epithelial lesions, leucocyte infiltration, vascular congestion and oedema. Later the irritation index was calculated. RESULTS: The irritation index was 11.0 (moderately irritant), 0.0 and 0.0 (none-irritant), in each group respectively. CONCLUSION: It appears that the administration of the coated alendronate tablets reduces the frequency and intensity of the local adverse events from the gastrointestinal tract.