Comprehensive therapy in osteoporosis using a single drug: from ADFR to strontium ranelate.

In vitro, strontium ranelate increases collagen and non-collagenic proteins synthesis by mature osteoblast enriched cells. The effects of strontium ranelate on bone formation were confirmed as the drug enhanced preosteoblastic cell replication. In the isolated rat osteoclast, a preincubation of bone slices with strontium ranelate induced a dose-dependent inhibition of the bone resorbing activity of treated rat osteoclast. Strontium ranelate dose-dependently inhibited preosteoclast differentiation. In a phase II dose ranging trial Strontium ranelate (500 mg, 1000 mg, 2000 mg/day) or placebo were given to 353 postmenopausal women with prevalent vertebral osteoporosis. At the conclusion of this 2-year study, the annual increase in lumbar BMD of the group receiving 2000 mg of strontium ranelate was + 7.3%, a significant increase in bone alkaline phosphatase, over a 6-month period and a significant decrease in N-telopeptide crosslinks throughout the 2-year period were seen. During the second year of treatment, the dose of 2000 mg was associated with a 44% reduction in the number of patients experiencing a new vertebral deformity. The primary analysis of the SOTI study, evaluating the effect of strontium ranelate 2000 mg on vertebral fracture rates, revealed a 41% reduction in the relative risk of patient experiencing a first new vertebral fracture with strontium ranelate throughout the 3-year study. The TROPOS study showed a significant reduction in the risk of experiencing a first non-vertebral fracture by 16% in the group treated with strontium ranelate throughout the 3-year study. A reduction in the risk of experiencing a hip fracture by 36% was also demonstrated in the patients at high risk of hip fracture (age > or =74 years and Femoral Neck T score < or = -2.4 according to NHANES normative value). All these results suggest that strontium ranelate is a new, effective and safe treatment of vertebral and non-vertebral osteoporosis, with a unique mode of action.

The direct and indirect costs of the chronic management of osteoporosis: a prospective follow-up of 3440 active subjects.

INTRODUCTION: The objective of this study was to estimate the direct and indirect costs attributable to osteoporosis (OP) from a societal and a payer's perspective among active subjects living in Belgium and employed in the public workforce. MATERIALS AND METHODS: A cohort of 3440 subjects employed by the Liege City Council was followed for 6 months. The City Council employees were invited to fill a monthly log of the data related to their utilization of health resources (contacts with health professionals, medical examinations, drug use,...) due to OP. Information on work disability (number of days of sick leave) and on informal care (number of days off work incurred by active subjects in helping relatives or friends suffering from OP) was also collected. RESULTS: Of those asked to participate in the study, 1,811 subjects filled in at least one questionnaire. The mean duration of follow-up was 3.46 months. Self-reported prevalence of OP at inclusion was 5.3%. OP subjects were significantly older (52.7+/-6.1 years) than normal subjects (45.5+/-9.8 years) (p<0.05) and included more women (85.3 vs. 55.9%). Direct costs came to 44.6 euros per OP patient-month: 10.9 euros was spent on contact with health professionals, 19.0 euros on medical examinations, 12.1 euros on drugs and 2.6 euros on hospitalizations. During this 6-month study, a total of 140 days of sick leave was recorded (mean: 0.4 per OP patient-month). From a payer's perspective, this loss in productivity yielded a mean cost of 34.05 euros per OP patient-month. A mean number of days off work of 0.018 per active subject-month, attributable to informal care, was recorded. These days of inactivity represented, for the employer, a mean cost of 1.8 euros per active subject-month. CONCLUSION: The results of this survey of a large sample of active subjects confirm that OP-related expenditures, both for medical care and for loss of productivity, are significant.