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ARTICLES: Yoshihiro Sato, Jun Iwamoto, Tomohiro Kanoko, and Kei Satoh Risedronate therapy for prevention of hip fracture after stroke in elderly women Neurology 2005; 64: 811-816 [Abstract] [Full text] [PDF]

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Risedronate therapy for prevention of hip fracture after stroke in elderly women

Kenneth E S Poole, Elizabeth A. Warburton and Jonathan Reeve   (23 May 2005)

Reply to Poole et al

Yoshihiro Sato, Jun Iwamoto, MD; Tomohiro Kanoko, PhD; and Kei Satoh, MD   (23 May 2005)

Risedronate therapy for prevention of hip fracture after stroke in elderly women 23 May 2005
Kenneth E S Poole, University of Cambridge Box 157, Department of Medicine, Addenbrooke's Hospital, Hills Road, Cambridge, CB2 2QQ, Elizabeth A. Warburton and Jonathan Reeve Send Correspondence to journal: Re: Risedronate therapy for prevention of hip fracture after stroke in elderly women kesp2{at}cam.ac.uk Kenneth E S Poole, et al.	The article by Sato et al reported a reduction in hip fractures following stroke using oral risedronate. [1] Fractures following stroke are recognized and intervention studies necessary [2] but there are several omissions in this article which are a barrier to assessing the validity and applicability of these results. [3] There are no details regarding how the sample size was determined, particularly important in hip fracture intervention trials where the event rate is low. Secondly, without details of baseline stroke severity, Barthel index and stroke classification, it is difficult for clinicians to know which stroke patients may benefit from the intervention, given the heterogeneity of the disease. The patients presumably had mild disability because those unable to stand or swallow were excluded. Males, those with dysphasia (based on the assumption that written informed consent was required) and those on anticoagulants were also excluded. In our acute stroke service with a catchment area of 500,000, <10% of admissions would fulfill these criteria (n=15 in four months) and yet the authors recruited 374 patients in this period. Formal description of the flow of patients through each stage of the study [3] would provide information on inclusion rates and acceptance rates. The definition of 'fallers' is open to misinterpretation, since someone who fell once is not distinguished from a recurrent faller. Although the total number of falls was equivalent between groups, the number of falls per patient is crucial in assessing whether the lower fracture rate is due solely to the efficacy of the intervention. Recurrent falls are common after stroke. In one study, 19% of patients fell once within a year but 29% fell repeatedly. [4] Finally, the radiographic prevalence of vertebral fractures in unselected postmenopausal Japanese women (mean age 65.4 +/-9.8) was 9.5% in one series [5], so the assertion that 187 postmenopausal women had no evidence of vertebral abnormalities raises concerns about the accuracy of assessment or how representative the sample was. This study is potentially of great importance given the scale of the problem of hip fractures following stroke and the paucity of interventions to date, and we congratulate the authors on their achievement. The concerns we raise can be addressed simply, since the relevant details were recorded. By providing this information, the impact of this study on clinical practice and further research will be enhanced. References 1. Sato Y, Iwamoto J, Kanoko T, Satoh, K. Risedronate therapy for prevention of hip fracture after stroke in elderly women. Neurology 2005;64:811-816. 2. Poole KE, Reeve J, Warburton, EA. Falls, fractures, and osteoporosis after stroke: time to think about protection? Stroke 2002; 33:1432- 1436. 3. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel- group randomised trials. Lancet 2001; 357:1191-1194. 4. Lamb SE, Ferrucci L, Volapto S, Fried LP, Guralnik JM. Risk Factors for Falling in Home-Dwelling Older Women With Stroke: The Women's Health and Aging Study. Stroke 2003; 34:494-501. 5. Fujiwara S, Kasagi F, Masunari N, Naito K, Suzuki G, Fukunaga M. Fracture prediction from bone mineral density in Japanese men and women. J Bone Miner Res 2003;18:1547-1553.
Reply to Poole et al 23 May 2005
Yoshihiro Sato, Department of Neurology Mitate Hospital, 3237 Yugeta, Tagawa 826-0041, Japan, Jun Iwamoto, MD; Tomohiro Kanoko, PhD; and Kei Satoh, MD Send Correspondence to journal: Re: Reply to Poole et al y-sato{at}ktarn.or.jp Yoshihiro Sato, et al.	We appreciate the comments from Poole et al regarding our study on efficacy of risedronate therapy on hip fracture following an acute stroke. [1] Although we did not perform power calculation, we thought a trial size of 374 was appropriate due to our previous experience in a cohort study on hip fractures in stroke patients.[2] Baseline stroke severity (degree of hand paralysis according to Sandinavian Stroke Scale [SSS]) and Barthel index (BI) in the placebo and risedronate groups were 3.1±1.7, 3.1±1.2 (SSS), and 78±24, 77±24 (BI), respectively. The numbers of patients with cerebral hemorrhage and infarction in the placebo and risedronate groups were 40/147 and 41/146. Patients with dysphagia and those receiving anticoagulants were excluded. Our hospital treats mild acute stroke patients with clear consciousness but acute stroke patients with impaired consciousness are transferred to other hospitals. Thus, limited to women, many patients meet the inclusion criteria leading to high inclusion rates (71%) and acceptance rates. Our hospital is a specialized center for acute stroke and we treat about 2800 stroke patients per year. We agree that the definition of 'fallers' can be misinterpreted and it needs to be more specific since repeated falls may enhance the risk of fractures. However, there may not be any evidence that those who fell once are a different group of patients than those fell more than once. This point has to be addressed in future studies. We recruited 212 age-matched volunteers from the community, and 25 volunteers (12%) had vertebral abnormalities in spinal radiological examinations. Thus, we employed 187 postmenopausal women as the comparison group to discriminate BMD variations related to the treatment from those related to methods of measurement. References 1. Sato Y, Iwamoto J, Kanoko T, Satoh, K. Risedronate therapy for prevention of hip fracture after stroke in elderly women. Neurology 2005;64:811-816. 2. Sato Y, Asoh T, Kaji M, Oizumi K. Benefical effect of intermittent cyclical etidronate therapy in hemiplegic patients following an acute stroke. J Bone Mineral Res 2000;15; 2487-2494.