Format

Send to

Choose Destination
See comment in PubMed Commons below
J Bone Miner Res. 2011 May;26(5):984-92. doi: 10.1002/jbmr.292.

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

Collaborators (269)

Horowitz Z, Orloff J, Black D, Cummings S, Delmas P, Eastell R, Reid I, Boonen S, Cauley J, Cosman F, Lakatos P, Leung PC, Man Z, Lau E, Jasqui S, Mautalen C, Rosario-Jansen T, Caminis J, Eriksen EF, Mesenbrink P, Raisz L, Bauer P, Compston J, DeMets D, Hirschberg R, Johnell O, Ralston S, Wallace R, Farkough M, Flood M, Bauer D, Palermo L, Lang T, Kerzberg E, Man Z, Mautalen C, Ridruejo M, Tate G, Velasco J, Hooper M, Kotowicz M, Nash P, Prince R, Roberts A, Sambrook P, Dobnig H, Finkenstedt G, Hoefle G, Klaushofer K, Pecherstorfer M, Peichl P, Body J, Boonen S, Devogelaer JP, Geusens P, Kaufman J, Brenol J, Kochen J, Lederman R, Radominski S, Szejnfeld V, Zerbini C, Adachi J, Brown J, Choquette D, Hanley D, Josse R, Kendler D, Kremer R, Morin F, Olszynski W, Papaioannou A, KinYuen C, Chen B, Lin S, Casas N, Chalem M, Jaller J, Molina J, Aro H, Heikkinen J, Kröger H, Mäkinen L, Saltevo J, Salmi J, Välimäki M, Benhamou CL, Delmas P, Fardellone P, Werhya G, Allolio B, Felsenberg D, Happ J, Hartard M, Hensen J, Kaps P, Kekow J, Moericke R, Ortloff B, Schneider P, Wassenberg S, Leung PC, Balogh A, Gomor B, Hidvégi T, Koranyi L, Lakatos P, Poór G, Tulassay Z, Pollak RD, Eshed V, Foldes AJ, Ish-Shalom S, Vered I, Weiss M, Adami S, Barone A, Bianchi G, Giannini S, Isaia GC, Luisetto G, Minisola S, Molea N, Nuti R, Ortolani S, Passeri M, Rubinacci A, Seriolo B, Sinigaglia L, Choi WH, Kang MI, Kim GS, Kim HS, Kim YK, Lim SK, Son HY, Yoon HK, Abud C, Garcia P, Jasqui S, Ochoa L, Orozco J, Santos J, Reid I, Elle S, Halse J, Høiseth A, Olav H, Røed HI, Skag A, Stakkestad J, Syversen U, Badurski J, Czerwinski E, Lorenc R, Marcinowska-Suchowierska E, Sawicki A, Supronik J, Ailamazyan E, Benevolenskaya L, Dreval A, Dvoretsky L, Dyomina R, Mazurov V, Melnichenko G, Mkrtoumyan A, Orlov-Morozov A, Ostroumova O, Pikhlak E, Shemerovskaya T, Shostak N, Skripnikova I, Smetnik V, Tsyrlina E, Usova G, Zalevskaya A, Zazerskaya I, Zotkin E, Ljunggren O, Lofgren J, Palmér M, Saaf M, Stenström M, Hasler P, Lamy O, Lippuner K, Merlin C, Rizzoli R, Theiler R, Tyndall A, Uebelhart D, Chen JF, Chen PQ, Chin LS, Hwang JS, Yang TS, Jirapinyo M, Jirapinyo M, Sattaya R, Sriussadaporn S, Supasin S, Taechakraichana N, Wilawan K, Donnachie H, Eastell R, Fraser W, McLellan A, Reid D, Abruzzo J, Ackerman R, Adler R, Aloia J, Birbara C, Bode B, Bone H, Brandon D, Cauley J, Cosman F, Dionne D, Downs R Jr, Dreyfus J, Elinoff V, Emkey R, Fanciullo J, Fiske D, Genaro P, Gollapudi M, Gordon R, Hennessey J, Howard P, Johnson K, Johnston C, Kagan R, Kafka S, Kaine J, Klein T, Koltun W, Leboff M, Levine B, Lewiecki EM, Lewis CE, Licata A, Lillestol M, Lubin B, Malamet R, Mangione A, Matkovic V, Mehta D, Miller P, Miller S, Murphy FT, Nattrass S, Podlecki D, Recknor C, Rosen C, Rowe D, Rude R, Schnitzer T, Sherrer Y, Silverman S, Stephenson K, Troupin B, Tucci J, Villareal R, Watts N, Weinstein R, Weinstein R, Weitz M, White R.

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 self-reported 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 = .0092). The back pain among women randomized to zoledronic acid versus placebo resulted in 11 fewer days of limited activity (p = .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) = 0.94, 95% confidence interval (CI) 0.90-0.99] or limited activity owing to back pain (RR = 0.94, 95% CI 0.87-1.00). Women randomized to zoledronic acid were significantly less likely to experience 7 or more bed-rest days owing to a fracture (RR = 0.58, 95% CI 0.47-0.72) and 7 or more limited-activity days owing to a fracture (RR = 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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00049829.

PMID:
21542001
PMCID:
PMC5104553
DOI:
10.1002/jbmr.292
[PubMed - indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Wiley Icon for PubMed Central
    Loading ...
    Support Center