S. Ortolani

Relationship between change in femoral neck bone mineral density and hip fracture incidence during treatment with strontium ranelate

ABSTRACT Objective: Strontium ranelate (SR) increases bone mineral density (BMD) in postmenopausal osteoporotic women and reduces vertebral and non-vertebral fracture incidence. Hip fracture reduction has also been observed during 3-year treatment with SR in osteoporotic women at high risk of hip fracture. The objective of this study is to analyse the association between BMD changes and hip fracture incidence during treatment with SR. Material and methods: In this post-hoc analysis, 465 women aged over 74 years with low BMD at the femoral neck (T-score ≤ –2.4 according to NHANES normative values) were selected from the population of a recently published study (the Treatment of Peripheral Osteoporosis Study – TROPOS). BMD was assessed at the femoral neck at baseline and after a follow-up of 3 years. Hip fractures were reported by study investigators. Results: After adjusting for age, body mass index, femoral neck BMD at baseline and number of prevalent vertebral fractures, we found that for each 1% increase in femoral neck BMD observed after 3 years, the risk to experience a hip fracture after 3 years decreased by 7% (95% CI: 1–14%) ( p = 0.04). In patients experiencing a hip fracture over 3 years of treatment with SR, femoral neck BMD increased by (mean [SE]) 3.41 (1.02)% compared to 7.23 (0.81)% in patients without hip fracture ( p = 0.02). Conclusion: In this post-hoc analysis of women undergoing 3 years of SR treatment, an increase in femoral neck BMD is associated with a decrease in hip fracture incidence.

Prevalence of osteoporosis and fractures among women prescribed osteoporosis medication in five European countries: the POSSIBLE EU study.

SummaryEuropean observational 1-year study assessed osteoporosis and fracture patterns in 3,402 postmenopausal women prescribed osteoporosis medication. Almost 40% of patients had a previous fracture, while 25% had neither fracture nor dual energy X-ray absorptiometry (DXA) diagnosis and were prescribed medication, probably due to other risk factors.IntroductionThis analysis assessed osteoporosis and fracture prevalence in postmenopausal women prescribed osteoporosis treatment in the Prospective Observational Study Investigating Bone Loss Experience in Europe(POSSIBLE EU®).MethodsWomen in this observational, multicenter 1-year study were categorized by fracture history and location at baseline. Baseline characteristics were analyzed according to no DXA and DXA diagnosis (osteoporosis or osteopenia). Fractures occurring during the 1-year follow-up period were recorded.ResultsOf the 3,402 women enrolled, 39% had a previous fracture, of whom 30% had ≥2 fractures. One thousand seven hundred and eighty-four (52%) patients had a DXA diagnosis (osteoporosis 68%, osteopenia 31%, and unknown 1%). Among the osteoporosis patients, 37% had a previous fracture (hip 2.9%, vertebral 8.8%, and non-hip, non-vertebral 25%) and 35% had fractures associated with major trauma. Of the 3,402 women, 1,476 (43%) had no DXA diagnosis; of these, 57% had no fracture (25% of all women). Risk factors varied across patients with and without DXA diagnosis. During the 1-year follow-up period, the fracture incidence in patients with or without a previous fracture at baseline was 4.7% and 1.6%, respectively.ConclusionAlmost 40% of patients prescribed osteoporosis medication had a previous fracture, highlighting a population with advanced disease. In contrast, 25% of patients had neither a previous fracture nor DXA diagnosis and were prescribed treatment, probably due to other risk factors. There is a need for continued improvement of disease management in European women.

The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal Osteoporosis

Strontium ranelate is an orally active agent that stimulates new bone formation and decreases bone resorption. A recent phase 2 placebo-controlled study of postmenopausal women with osteoporosis indicated a reduction in vertebral fractures and increased bone mineral density (BMD). The present phase 3 trial, the Spinal Osteoporosis Therapeutic Intervention study, evaluated strontium ranelate, given orally in a dose of 2 g daily for 3 years, in women aged 50 years and older who had been postmenopausal for at least 5 years, had had at least 1 spinal fracture, and had a lumbar spine BMD of 0.84 g/cm 2 or lower. A total of 1442 women were randomized to receive strontium ranelate or placebo and were included in an intention-to-treat analysis. All women received calcium and vitamin D supplements. BMD was estimated at 6-month intervals, and spinal radiographs were obtained each year. After 12 months, the risk of a new vertebral fracture was 49% lower in women given strontium ranelate (6.4% vs. 12.2%) for a relative risk of 0.51. Symptomatic fractures were decreased 52%. The reduction in risk of a new spinal fracture persisted throughout the 3-year study period. The risk of having more than 1 new vertebral fracture was 6.4% in the study group and 9.8% in placebo recipients. Fewer patients in the study group lost 1 cm or more in height (30.1% vs. 37.5%). Nonvertebral fractures were similarly frequent in the 2 groups. BMD in the lumbar spine increased by 12.7% in strontium-treated women. None of 14 bone biopsies disclosed osteomalacia or signs of a primary defect in mineralization. Compliance rates were 83% and 85% in the study and placebo groups, respectively. Diarrhea, the most common adverse gastrointestinal effect, tended to resolve after 3 months of treatment. Serum calcium levels were lower and serum phosphate levels higher in strontium-treated women. Strontium ranelate provides a rapid and lasting reduction in the risk of vertebral fractures in postmenopausal women with osteoporosis.