BACKGROUND AND PURPOSE: Stroke is a major risk factor for hip fracture. Patients with intermediate rather than severe or mild stroke deficits at the time of hospital discharge have the most fractures. This proof-of-concept study evaluated the efficacy of a single infusion of zoledronate, an intravenous bisphosphonate, in preserving hip bone density after stroke. METHODS: In a 1-year randomized, double-blind, placebo-controlled, clinical trial, 27 newly hemiplegic patients (6 females, 21 males) with acute stroke were assigned to receive 4 mg of the intravenous zoledronate (n=14) or placebo (n=13) within 35 days. Strict inclusion criteria were followed-up to ensure recruited patients were likely to have residual functional impairment. Both groups received calcium and vitamin D supplementation. The primary outcome measure was the change in bone mineral density (BMD; Lunar Prodigy) at the hemiplegic hip during the year of investigation. RESULTS: The treatment was generally well tolerated. Mean total hip BMD was unchanged in the hemiplegic hip of the zoledronate group (mean 0.0% change), whereas in the placebo group the total hip BMD changed by -5.5%, with the greatest bone loss observed in the trochanteric subregion (mean, -8.1%). On the unaffected side the mean change in total hip BMD was +1.0% with zoledronate versus a mean change of -2.7% without. Repeated measures ANOVA confirmed the significance of the differences between groups at both hips (hemiplegic, P<0.001; unaffected, P=0.002). CONCLUSIONS:Stroke patients were protected from the deleterious effects of hemiplegia on hip bone density for at least 1 year after a single infusion of zoledronate.
RCT Entities:
BACKGROUND AND PURPOSE:Stroke is a major risk factor for hip fracture. Patients with intermediate rather than severe or mild stroke deficits at the time of hospital discharge have the most fractures. This proof-of-concept study evaluated the efficacy of a single infusion of zoledronate, an intravenous bisphosphonate, in preserving hip bone density after stroke. METHODS: In a 1-year randomized, double-blind, placebo-controlled, clinical trial, 27 newly hemiplegic patients (6 females, 21 males) with acute stroke were assigned to receive 4 mg of the intravenous zoledronate (n=14) or placebo (n=13) within 35 days. Strict inclusion criteria were followed-up to ensure recruited patients were likely to have residual functional impairment. Both groups received calcium and vitamin D supplementation. The primary outcome measure was the change in bone mineral density (BMD; Lunar Prodigy) at the hemiplegic hip during the year of investigation. RESULTS: The treatment was generally well tolerated. Mean total hip BMD was unchanged in the hemiplegic hip of the zoledronate group (mean 0.0% change), whereas in the placebo group the total hip BMD changed by -5.5%, with the greatest bone loss observed in the trochanteric subregion (mean, -8.1%). On the unaffected side the mean change in total hip BMD was +1.0% with zoledronate versus a mean change of -2.7% without. Repeated measures ANOVA confirmed the significance of the differences between groups at both hips (hemiplegic, P<0.001; unaffected, P=0.002). CONCLUSIONS:Strokepatients were protected from the deleterious effects of hemiplegia on hip bone density for at least 1 year after a single infusion of zoledronate.
Authors: K Naruse; K Uchida; M Suto; K Miyagawa; A Kawata; K Urabe; M Takaso; M Itoman; Y Mikuni-Takagaki Journal: J Bone Miner Metab Date: 2015-10-16 Impact factor: 2.626
Authors: Lynda D Lisabeth; Lewis B Morgenstern; Jeffrey J Wing; Brisa N Sanchez; Darin B Zahuranec; Lesli E Skolarus; James F Burke; Michael Kleerekoper; Melinda A Smith; Devin L Brown Journal: J Stroke Cerebrovasc Dis Date: 2011-02-21 Impact factor: 2.136
Authors: Kenneth E S Poole; Shobna Vedi; Irene Debiram; Collette Rose; Jon Power; Nigel Loveridge; Elizabeth A Warburton; Jonathan Reeve; Juliet Compston Journal: Bone Date: 2008-12-11 Impact factor: 4.398