Long-term fracture rates seen with continued ibandronate treatment: pooled analysis of DIVA and MOBILE long-term extension studies.

UNLABELLED: Ibandronate reduces the risk of vertebral and non-vertebral fractures versus placebo in postmenopausal women with osteoporosis. This analysis, in which fractures were reported as safety events, showed that long-term use of ibandronate was associated with low fracture rates over 5 years of treatment. INTRODUCTION: A previous post-hoc meta-analysis of 2-3 year studies found that ibandronate regimens with annual cumulative exposure (ACE) of ≥10.8 mg reduced the risk of vertebral and nonvertebral fractures (NVFs) versus placebo in postmenopausal women. This post-hoc analysis used individual patient data from the 2-year monthly oral ibandronate in ladies (MOBILE) and dosing intravenous administration (DIVA) studies, including the 3-year long-term extensions (LTEs), to assess fracture risk in patients treated with ibandronate for 5 years. METHODS: Patients treated for 2 years in MOBILE with monthly oral ibandronate 150 mg (n = 176) and in DIVA with IV ibandronate every 2 months 2 mg (n = 253) or quarterly 3 mg (n = 263) who continued on the same regimens for 3 additional years in the LTEs were included. Three-year placebo data (n = 1,924) were obtained from the ibandronate osteoporosis vertebral fracture trial in North America and Europe (BONE) and IV Fracture Prevention trials. The primary endpoint was clinical fracture rate; clinical fracture data were collected as adverse events. Time to fracture was analyzed using Kaplan-Meier and statistical analysis was conducted using the log-rank test. All clinical fractures included all NVFs and symptomatic vertebral fractures. RESULTS: For ibandronate regimens with ACE ≥10.8 mg, time to fracture was significantly longer for all clinical fractures, NVFs, and clinical vertebral fractures versus placebo (P = 0.005). For all fracture types, the rate of fracture appeared stable during the 5-year treatment period. CONCLUSION: In women with postmenopausal osteoporosis, continuous treatment with ibandronate over 5 years results in low sustained clinical fracture rate.

Efficacy of monthly oral ibandronate is sustained over 5 years: the MOBILE long-term extension study.

UNLABELLED: The long-term efficacy and safety of once-monthly ibandronate were studied in this extension to the 2-year Monthly Oral Ibandronate in Ladies (MOBILE) trial. Over 5 years, lumbar spine bone mineral density (BMD) increased from baseline with monthly ibandronate 150 mg (8.4%). Long-term monthly ibandronate is effective and well tolerated for up to 5 years in women with postmenopausal osteoporosis. INTRODUCTION: Once-monthly therapy with ibandronate has been studied for up to 5 years in a long-term extension (LTE) to the 2 year MOBILE trial. METHODS: This multicenter, double-blind extension study of monthly ibandronate involved postmenopausal women who had completed 2 years of the MOBILE core study, with ≥75% adherence. Patients were reallocated, or were randomized from daily therapy, to ibandronate 100 mg monthly or 150 mg monthly for a further 3 years. RESULTS: A pooled intent-to-treat (ITT) analysis of 344 patients receiving monthly ibandronate from the core MOBILE baseline showed increases over 5 years in lumbar spine BMD (8.2% with 100 mg and 8.4% with 150 mg). Three-year data relative to MOBILE LTE baseline in the full ITT population of all 698 patients randomized or reallocated from MOBILE (including those previously on daily treatment) showed, on average, maintenance of proximal femur BMD gains achieved in the core 2-year study, with further small gains in lumbar spine BMD. In general, maintenance of efficacy was also indicated by markers of bone metabolism. CONCLUSIONS: There were no tolerability concerns or new safety signals. Monthly treatment with ibandronate 100 and 150 mg is effective and well tolerated for up to 5 years in women with postmenopausal osteoporosis.

Rate of characteristics for osteoporotic fractures in the elderly population of Kaunas region, Lithuania.

Osteoporosis related with age is a well known problem in many Western countries. First investigations on osteoporosis in Lithuania were started few years ago. We investigated the rate of characteristic for osteoporosis fractures according to Kaunas Red Cross Hospital regional Traumatology department data. We have studied all cases of inpatients and outpatients over 65, who had Colles', hip or vertebral fracture, as this department serves for all Kaunas region, (580000 inhabitants: 17000 male and 35500 female over 65). The rate of fractures was counted per 1000 inhabitants over 65, comparing 1991 and 1993. We found, that about 1.65/1000 of men and 7.52/1000 of women had Colles' fracture in 1991, when the rate in 1993 accordingly was 1.60/1000 and 10.56/1000. The greater increase in rate we noticed studying cases of hip fractures: 1.60/1000 of men and 3.09/1000 of women in 1991, when 4.70/1000 of men and 6.76/1000 of women in 1993. We did not noticed a significant increase in vertebral fractures comparing number of inpatients in 1991 and 1993: 0.64/1000 of men and 0.59/1000 of women in 1991 and 0.65/1000 in 1993 of both sexes. We did notice the important role of falls to fracture rate, as increase of hip and Colles' fractures increased more than 2 times in winter season. Evaluating our data, we make a conclusion, that the rate of osteoporotic fractures increased comparing 1991 and 1993: Colles' fracture- 1,5 times and hip fracture 2 times in women group, when in men's group Colles' fracture rate did not change significantly and hip fracture increased 2,9 times. The growing number of fracture's rate in population over 65 shows, that problem of involutional bone disorders exists in Lithuania also.