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.

Switching from one generic alendronate to another--a common procedure in Poland in the years 2001-2005.

INTRODUCTION: In clinical ambulatory practice, patients often, rather than discontinuing treatment, change to another one. This study aims to assess the reasons why patients with osteoporosis switch from one alendronate to another with a different brand name. MATERIAL AND METHODS: A retrospective analysis of 747 bisphosphonate-treated patients was performed (651 female, average age 67.3 ± 8.9 years, BMI 26.5 ± 4.0 kg/m(2)). The frequency and reasons for drug switching during the 19.4 ± 13.4 months of observation were analysed. RESULTS: In 387 (51.8%) patients, treatment was not changed during the observation period, whereas in 360 (48.2%) patients, at least one drug switch occurred. Almost 40% of patients from that group (138 patients) switched from one alendronate to another alendronate with a different brand name. The most frequent reasons were: adverse event (36.9%), high price of the drug (23.2%) and request of patient (16.7%). CONCLUSIONS: A substantial proportion of persistent bisphosphonate-treated patients switch treatment from one alendronate to another. The most frequent reasons for that kind of switching are the occurrence of an adverse event and the high cost of treatment.

WHO fracture risk calculator (FRAX) in the assessment of obese patients with osteoporosis.

INTRODUCTION: Recently, a new fracture risk-assessment calculator (FRAX) has been introduced. The aim of this study was to assess its usefulness for the re-assessment of fracture risk in obese patients and re-assignment to treatment. MATERIAL AND METHODS: 350 obese female patients were included. In all of them, 10-year fracture risk was calculated using FRAX (with and without T score value). RESULTS: If major osteoporotic fracture risk was calculated with BMD, it was low in most of the patients (in 82.1% of those treated, and in 95.9% of those not treated it was below 10%). Mean risk values were significantly higher in the treated (7.7 [3;39]%) than in the non-treated group (4.6 [2.1;14]%). The reason for start of treatment in 95 out of 106 patients was a sustained low-energy fracture, low BMD, or both. CONCLUSIONS: The WHO fracture risk calculator may be a useful tool in treated obese females with osteoporosis. The information regarding 10-year fracture risk may change the treatment strategy at least for those in whom the decision of treatment was based solely on low BMD.

Common drug switching during long-term antiresorptive treatment: experience of four osteoporosis centers in Poland (2001-2005).

BACKGROUND AND AIMS: In clinical trials, the most frequent reasons for treatment discontinuation are adverse events and personal conflicts with medical staff. However, in "real life", i.e. not in the frame of a controlled and monitored trial, other reasons are also possible, when not only discontinuation, but also switching of treatment happens. The aim of this study was to estimate how often and why persistent osteoporosis patients switch from one treatment to another. METHODS: A retrospective analysis of 1314 ambulatory treated persistent osteoporosis patients was performed (1180 F, 134 M, mean age+/-SD: 66.5+/-10 yrs, BMI 26.4+/-4.2 kg/m2). Drugs used for osteoporosis, duration of treatment, frequency and reasons for drug switching were all analyzed. RESULTS: In 530 (40.3%) patients, treatment was not changed during the observation period (16.1+/-9.1 months). In 784 (59.7%) patients at least one drug switch happened, and the total number of switches was 1117 (1- 5 switches/patient). The mean time of observation in this group was 22.3+/-14.9 months. The most frequent reasons for drug switching were: adverse event (34.6% of all switches), high price of the drug (28.7%) and ineffective treatment (13.3%). CONCLUSIONS: In almost 60% of the persistent patients, at least one switch of antiosteoporotic treatment occurred in the nearly 2- year observation period. The most frequent reasons for drug switching were adverse reactions, the high price of the drug, and ineffective treatment.