Once-yearly zoledronic acid and days of disability, bed rest, and back pain: Randomized, controlled HORIZON Pivotal Fracture Trial

Abstract

The objective of this study was to determine the effect of once-yearly zoledronic acid on the number of days of back pain and the number of days of disability (ie, limited activity and bed rest) owing to back pain or fracture in postmenopausal women with osteoporosis. This was a multicenter, randomized, double-blind, placebo-controlled trial in 240 clinical centers in 27 countries. Participants included 7736 postmenopausal women with osteoporosis. Patients were randomized to receive either a single 15-minute intravenous infusion of zoledronic acid (5 mg) or placebo at baseline, 12 months, and 24 months. The main outcome measures were selfreported number of days with back pain and the number of days of limited activity and bed rest owing to back pain or a fracture, and this was assessed every 3 months over a 3-year period. Our results show that although the incidence of back pain was high in both randomized groups, women randomized to zoledronic acid experienced, on average, 18 fewer days of back pain compared with placebo over the course of the trial ( p ¼ .0092). The back pain among women randomized to zoledronic acid versus placebo resulted in 11 fewer days of limited activity ( p ¼ .0017). In Cox proportional-hazards models, women randomized to zoledronic acid were about 6% less likely to experience 7 or more days of back pain [relative risk (RR) ¼ 0.94, 95% confidence interval (CI) 0.90-0.99] or limited activity owing to back pain (RR ¼ 0.94, 95% CI 0.87-1.00). Women randomized to zoledronic acid were significantly less likely to experience 7 or more bedrest days owing to a fracture (RR ¼ 0.58, 95% CI 0.47-0.72) and 7 or more limited-activity days owing to a fracture (RR ¼ 0.67, 95% CI 0.58-0.78). Reductions in back pain with zoledronic acid were independent of incident fracture. Our conclusion is that in women with postmenopausal osteoporosis, a once-yearly infusion with zoledronic acid over a 3-year period significantly reduced the number of days that patients reported back pain, limited activity owing to back pain, and limited activity and bed rest owing to a fracture. ß

Sources of pain in osteoarthritis: implications for therapy

“…Interestingly, there is a study in the bone literature demonstrating that zoledronate improved back pain in a clinical trial, and this was independent of changes in bone mass or fracture risk. The mechanism is uncertain but it is reasonable to hypothesize that it may be helping Modic change [68].…”

Kwas zoledronowy stosowany przez dwa lata u Chinek z osteoporozą pomenopauzalną zwiększa gęstość mineralną tkanki kostnej i poprawia jakość życia związaną ze stanem zdrowia

“…However, there is little data directly assessing the effects of bisphosphonate treatment on HRQL in postmenopausal women with osteoporosis. In an analysis of the HORIZON-PFT trial, patients treated with ZOL experienced significantly fewer days of limited activity caused by back pain or fracture compared to those receiving a placebo [28]. And it has been reported that ZOL therapy also reduces the number of bed days due to a fracture [29].…”

Once-yearly zoledronic acid 5 mg therapy for osteoporosis: a focus on a patient

“…Из-за бо-язни боли пациенты вынуждены осторожно двигаться, что приводит к ухудшению физического состояния, детрениро-ванности и даже беспомощности. По данным недавно опуб-ликованного анализа данных HORIZON-PFT [78], терапия золедроновой кислотой 5 мг по сравнению с плацебо в тече-ние 3 лет значительно снижала количество дней ограниче-ния активности вследствие боли в спине (61 против 72; p=0,0076) или переломов (6 против 10; p=0,001). По сравне-нию с плацебо в группе лечения на 6% меньше женщин от-метили боль в спине, длящуюся 7 дней и более.…”