T B Kaye1. 1. Section of Endocrinology, Diabetes, and Metabolism, Lahey Clinic Medical Center, Burlington, Massachusetts, USA.
Abstract
OBJECTIVE: To determine the long-term effect of an inhaled glucocorticoid, flunisolide, on bone mineral density in a prospective, controlled study. METHODS:Patients with asthma treated with inhaled glucocorticoids, but not requiring other types of glucocorticoid treatment, were recruited as study patients (N = 11). All study patients were treated with inhaled flunisolide, 500 mg twice a day for a 2-year period, for consistency. Patients with asthma not requiring any type of glucocorticoid treatment were recruited as control subjects (N = 18). All patients were between the ages of 30 and 50 years, and all female patients were premenopausal. Measurements of bone mineral density, serum bone-specific alkaline phosphatase, serum osteocalcin, 24-hour urine hydroxyproline-to-creatinine ratio, forced expiratory volume in 1 second/forced vital capacity, and forced expiratory flow, midexpiratory phase were obtained at baseline and repeated in 1 year and again in 2 years. RESULTS: No statistically significant changes were noted in bone mineral density measured at the lumbar spine, femoral neck, Ward's triangle, or femoral trochanter in the users of inhaled flunisolide in comparison with the control subjects at 1 year or at 2 years, with one exception. The percentage change from baseline of bone mineral density measured at the femoral trochanter at 1 year was greater in the inhaled flunisolide users than in the control group, 3.1% versus -0.8%, respectively (P = 0.01). No statistically significant changes were found in markers of bone turnover or measures of asthma severity. CONCLUSION:Inhaled flunisolide, administered in standard doses, had no deleterious effect on bone mineral density or on biochemical markers of bone turnover after a 2-year period.
RCT Entities:
OBJECTIVE: To determine the long-term effect of an inhaled glucocorticoid, flunisolide, on bone mineral density in a prospective, controlled study. METHODS:Patients with asthma treated with inhaled glucocorticoids, but not requiring other types of glucocorticoid treatment, were recruited as study patients (N = 11). All study patients were treated with inhaled flunisolide, 500 mg twice a day for a 2-year period, for consistency. Patients with asthma not requiring any type of glucocorticoid treatment were recruited as control subjects (N = 18). All patients were between the ages of 30 and 50 years, and all female patients were premenopausal. Measurements of bone mineral density, serum bone-specific alkaline phosphatase, serum osteocalcin, 24-hour urine hydroxyproline-to-creatinine ratio, forced expiratory volume in 1 second/forced vital capacity, and forced expiratory flow, midexpiratory phase were obtained at baseline and repeated in 1 year and again in 2 years. RESULTS: No statistically significant changes were noted in bone mineral density measured at the lumbar spine, femoral neck, Ward's triangle, or femoral trochanter in the users of inhaled flunisolide in comparison with the control subjects at 1 year or at 2 years, with one exception. The percentage change from baseline of bone mineral density measured at the femoral trochanter at 1 year was greater in the inhaled flunisolide users than in the control group, 3.1% versus -0.8%, respectively (P = 0.01). No statistically significant changes were found in markers of bone turnover or measures of asthma severity. CONCLUSION: Inhaled flunisolide, administered in standard doses, had no deleterious effect on bone mineral density or on biochemical markers of bone turnover after a 2-year period.