RESUMEN
AIM: To evaluate the efficiency and safety of long-term Prolia therapy in patients with postmenopausal osteoporosis (OP). SUBJECTS AND METHODS: The open prospective study enrolled 98 women (mean age, 68±9 years; mean menopause duration, 17±4 years) with postmenopausal OP, who were followed up in an outpatient setting at the National Medical Research Center for Preventive Medicine and who had been treated with denosumab 60 mg subcutaneously every 6 months for 12 months or more. The maximum follow-up period was 4 years: 48, 29, 11, and 10 patients were treated for 12, 24, 36, and 48 months, respectively. The patients were allocated into 2 groups: those who received and those who had not previously received antiosteoporotic therapy. Bone mineral density (BMD) was measured using dual-energy X-ray densitometry of the lumbar spine (LI-LIV) and proximal femur (PF). The ten-year probability of major osteoporotic fractures was estimated once in 72 patients not previously receiving antiosteoporotic therapy before the prescription of denosumab. RESULTS: In the patients not previously receiving therapy, the median 10-year probability of major fractures using the FRAX algorithm was 14.9%; that of femoral neck (FN) fractures was 3.7%. During denosumab treatment, the BMD increase in the lumbar spine was 4.2% at 12 months, 7.5% at 24 months, was 8.8% at 36 months; that in FN was 3.1, 3.9, and 5.3%, that in PF was 2.8, 4.1, and 5%; and that in the 1/3 forearm was 0.9, 1.4, and 2.6%, respectively (p < 0.001). In the persons receiving and not previously receiving the therapy, the BMD increase was similar, i.e. there was an additional positive effect when switching to denosumab. The decrease in the serum concentration of C-terminal telopeptide of type I collagen (CTX-I) was 54% at 6 months after initiation of denosumab therapy (p < 0.001) and 72% at 12 months (p<0.001); and the achieved marker level remained unchanged at 48 months. Transition from the OP zone to osteopenia one was noted in 23 patients with low BMD (T-score -2.5 SD) in LI-LII and in 12 patients with that in FN at 12 months of denosumab therapy and this was in 25 patients at 24 months. Nine-eight patients receiving the first Prolia injection refused to continue treatment on their own; adverse events were not the reason for drug discontinuation. CONCLUSION: Therapy with denosumab was effective in increasing BMD in routine outpatient practice and in allowing 25% of patients to achieve target values of this indicator. The marked decrease in the level of the bone resorption marker STX suggested that the drug had antiresorptive potency. The frequency of adverse reactions was low, confirming the good tolerability and safety profile of the drug. The convenience of the scheme and route of drug administration contributed to strict compliance with the doctor's recommendations. Denosumab was effective in increasing BMD not only in untreated patients, but also in those who had previously received antiosteoporotic therapy. The pharmacokinetic characteristics of denosumab, which contribute to its uniform distribution in trabecular and cortical bone tissue, regardless of active bone remodeling, and the fact that the clearance of the drug is independent of kidney function offer an advantage of administering the drug to patients with significant loss of FN and radius BMD and of reducing kidney function.
Asunto(s)
Conservadores de la Densidad Ósea , Denosumab , Osteoporosis Posmenopáusica , Anciano , Densidad Ósea , Conservadores de la Densidad Ósea/uso terapéutico , Denosumab/uso terapéutico , Femenino , Humanos , Persona de Mediana Edad , Osteoporosis Posmenopáusica/tratamiento farmacológico , Estudios ProspectivosRESUMEN
AIM: To study an association between blood lipid composition and bone mass in Russian postmenopausal women. SUBJECTS AND METHODS: The cross-sectional study included 373 postmenopausal women aged 45-80 years who were examined to diagnose osteoporosis in outpatient settings. Height, body weight, and waist and hip circumferences (WC and HC) were measured before densitometry. Quetelet's index was calculated as a ratio of weight (kg) to height (m2). The concentration of lipids and apolipoproteins (apo) AÐ and B were measured by enzyme immunoassay. Bone mineral density (BMD) in the spine and proximal femur (PF) was estimated by dual-energy X-ray absorptiometry. RESULTS: According to bone mass, the patients were divided into three groups: 1) osteoporosis (OP); 2) osteopenia; 3) normal BMD. The levels of total cholesterol and high-density lipoprotein (HDL) cholesterol were significantly higher in the postmenopausal women with OP than in those with normal bone mass. There was a negative correlation of cholesterol and HDL cholesterol levels with lumbar spine BMD and that of HDL levels with BMD in the femoral neck (FN) and entire PF. The level of lipoprotein (a) (LPa) was significantly lower in the group of patients with OP and positively correlated with BMD in FN and entire PF. After adjustment for age, the duration of menopause, Quetelet's index, and WC/HC association remained only between LPa and FN BMD. CONCLUSION: Multivariate regression analysis failed to confirm a trend towards decreased BMD and increased HDL cholesterol. This suggests that the association of HDL cholesterol with bone mass is apparently mediated by other factors and, above all, with age, postmenopausal hormonal status and body weight.
Asunto(s)
Lipoproteínas/sangre , Osteoporosis Posmenopáusica , Posmenopausia/metabolismo , Absorciometría de Fotón/métodos , Anciano , Índice de Masa Corporal , Densidad Ósea , Estudios Transversales , Femenino , Humanos , Persona de Mediana Edad , Osteoporosis Posmenopáusica/sangre , Osteoporosis Posmenopáusica/diagnóstico , Osteoporosis Posmenopáusica/epidemiología , Federación de Rusia/epidemiología , Estadística como AsuntoRESUMEN
AIM: To analyse retrospectively quality of medical correction of modified risk factors (RF) and treatment of cardiovascular diseases (CVD) in patients with diabetes mellitus type (DM) 2 admitted to specialized endocrinological departments. MATERIAL AND METHODS: Analysis of medication policy of CVD RF was made retrospectively for 250 patients treated in endocrinological departments of Moscow hospital in 2003. RESULTS: Arterial hypertension, coronary heart disease were diagnosed in 93.2 and 87.2% examinees. History of myocardial infarction and brain stroke was in 8.4 and 6% patients. Statins were prescribed in 2.4% cases. Examination for dyslipidemia was not satisfactory. ACE inhibitors were prescribed in 71.2% patients. Aspirin was prescribed (18%) primarily by the cardiologist. CONCLUSION: Quality of medical prophylaxis of CVD RF in DM type 2 patients in the departments does not satisfy modern clinical recommendations.