OBJECTIVES: This postmarketing, observational study evaluated the safety and effectiveness of monthly intravenous (IV) ibandronate in Japanese patients with osteoporosis. METHODS: Eligible patients received monthly IV ibandronate 1mg for 12 months. Adverse drug reactions (ADRs) were evaluated. Changes in bone mineral density (BMD) and bone turnover markers (BTMs) were assessed using matched t-test analysis. Cumulative fracture rates were analyzed by Kaplan-Meier methodology. RESULTS: In total, 1062 patients were enrolled, of whom 1025 (n = 887 women, n = 138 men) were treated. Mean patient age was 77 years. Seventy-five ADRs were reported in 54 patients (5.26%). Four patients (0.39%) experienced serious ADRs, including one case of osteonecrosis of the jaw. Acute-phase reactions occurred in 21 patients (2.04%), and half of them arose after the first ibandronate injection. No new safety concerns were identified. Significant increases in BMD at 12 months relative to baseline were observed at the lumbar spine (4.84%, n = 187; 95% confidence interval [CI], 3.47%–6.21%), femoral neck (2.73%, n = 166; 95% CI, 1.46%–4.01%), and total hip (1.93%, n = 133; 95% CI, 0.80%–3.07%). Significant reductions were observed in all BTMs at 12 months (n = 174 in tartrate-resistant acid phosphatase-5b, n = 101 in procollagen type 1 N-terminal propeptide at baseline). The cumulative incidence of nontraumatic, new vertebral and nonvertebral fractures was 3.16% (95% CI, 2.12%–4.70%). Analyses in women only showed similar results to the overall population. CONCLUSIONS: These findings confirm the favorable safety and consistent effectiveness of ibandronate, and indicate that monthly IV ibandronate would be beneficial in daily practice for the treatment of Japanese patients with osteoporosis.
Asian Continental Ancestry Group ; Bone Density ; Bone Remodeling ; Drug-Related Side Effects and Adverse Reactions ; Female ; Femur Neck ; Hip ; Humans ; Incidence ; Japan ; Jaw ; Observational Study ; Osteonecrosis ; Osteoporosis ; Procollagen ; Prospective Studies ; Spine

Objective：The purpose of this study was to evaluate the effectiveness of a four-week short-term intensive rehabilitation on ataxia in patients with ambulatory spinocerebellar degeneration (SCD), using the Scale for the Assessment and Rating of Ataxia (SARA) total score and sub-score.Methods：This study included 23 SCD patients；we considered those with a SARA gait score of＜3 points. Our program included a one-hour training session with individualized instructions and a one-hour self-balance training session. Additionally, occupational or speech-language-hearing therapy was performed for one hour daily. Our program was conducted five days weekly for four weeks. We assessed the SARA total score and sub-score findings immediately, before the first and after the last interventions.Results：The SARA total, gait, stance, and heel-shin scores showed more significant improvement after intervention than before intervention (p＜0.05). The other SARA sub-scores were not significantly different between “before and after” interventions.Conclusion：The four-week short-term intensive rehabilitation on ataxia in patients with ambulatory spinocerebellar degeneration improved the SARA total score and ataxia of the trunk and lower limbs.

Objective：The purpose of this study was to evaluate the effectiveness of a four-week short-term intensive rehabilitation on ataxia in patients with ambulatory spinocerebellar degeneration (SCD), using the Scale for the Assessment and Rating of Ataxia (SARA) total score and sub-score.Methods：This study included 23 SCD patients；we considered those with a SARA gait score of＜3 points. Our program included a one-hour training session with individualized instructions and a one-hour self-balance training session. Additionally, occupational or speech-language-hearing therapy was performed for one hour daily. Our program was conducted five days weekly for four weeks. We assessed the SARA total score and sub-score findings immediately, before the first and after the last interventions.Results：The SARA total, gait, stance, and heel-shin scores showed more significant improvement after intervention than before intervention (p＜0.05). The other SARA sub-scores were not significantly different between “before and after” interventions.Conclusion：The four-week short-term intensive rehabilitation on ataxia in patients with ambulatory spinocerebellar degeneration improved the SARA total score and ataxia of the trunk and lower limbs.