Effects of alendronate and calcitonin on bone mineral density in postmenopausal osteoporotic women. An observational study.

OBJECTIVE: Alendronate and calcitonin are antiresorptive drugs that were used for the treatment of postmenopausal osteoporosis and were shown to increase bone mineral density (BMD). However, the effect of both drugs in daily clinical practice may differ from that observed in clinical trials. METHOD: About 50 postmenopausal osteoporotic women were observed during their first year of treatment. Among them, 32 patients used alendronate and 18 used calcitonin. Lumbar spine and femoral neck BMD were measured by dual energy X-ray absorptiometry (DXA) at baseline and after 1 year of therapy. Biochemical markers (B-ALP--bone-specific alkaline phosphatase, OTC--osteocalcin and DPD/UCr--deoxypyridinoline/creatinine ratio) of bone metabolism were measured at baseline and 6 months later. Patient compliance was assumed by tablet counting and verified at interview. Each patient was further questioned about her attitude towards the treatment, as well as her dairy product intake, physical activity, use of other medications, smoking and social status. MAIN OUTCOME MEASURE: (1) Annual percent change in BMD in lumbar spine and femoral neck after the one-year treatment with either alendronate or calcitonin. (2) The change in biochemical markers of bone turnover. RESULTS: The lumbar spine BMD significantly increased by 7.0% (P < 0.001), the femoral neck BMD by 4.3% (P < 0.01). OTC, B-ALP and DPD/UCr decreased significantly during the therapy with alendronate. Compliance with therapy was 79% (95% CI 68-90%). In the calcitonin-treated group, the lumbar spine BMD significantly increased by 3.1 % (P < 0.05), while the femoral neck BMD remained unchanged. OTC, B-ALP and DPD/UCr did not change significantly during the treatment with calcitonin. Compliance with calcitonin therapy was 87% (95% CI 63-110%). The annual change of BMD in both treatment groups was independent on all questioned factors. CONCLUSION: In daily practice, alendronate enhanced significantly BMD both in lumbar spine and femoral neck. Calcitonin showed increase only in the lumbar spine BMD.

Theoretical exposure of chronically treated patients to lipid lowering agents.

PURPOSE: The objective was to analyse the exposure to lipid lowering agents (LLA) using the databases of health insurance companies and to appraise its concordance with the findings of evidence based medicine. METHODS: Three health insurance companies' prescription based databases were analysed in the years 1997-2000. All inhabitants in the Czech Republic (CR) have to be insured. The insured person with a recorded prescription for LLA in the year of interest was defined as a patient, the insured person with a recorded prescription for LLA in the years bordering the year of interest was defined as a chronically treated patient. In the year of interest the percentage of chronically treated patients without LLA medication, with 'very low' (<122 defined daily doses (DDD)/year), 'low' (122-243 DDD/year) and 'adequate' (>243 DDD/year) consumption was determined. RESULTS: During the observed period the total consumption of LLA increased among 450 000 inhabitants twice (by 109.6%) to 24.8 DDD/1000 inhabitants/day. In 2000 the rate of the consumption of statins and fibrates represented 34.2 and 65.6% respectively. In 1998 33.5% and in 1999 41.0% of the chronically treated patients occurred in the 'adequate' consumption group. CONCLUSIONS: The signals of inappropriate drug treatment such as the preferred use of fibrates and low doses of LLA prescribed to the Czech population were identified. Conversely, the increasing proportion of the chronically treated patients belonging to the group with the 'adequate' consumption could be considered as a positive signal.