TY - JOUR
T1 - Two-year results of a randomized placebo-controlled trial of vertebroplasty for acute osteoporotic vertebral fractures
AU - Kroon, Feline
AU - Staples, Margaret
AU - Ebeling, Peter Robert
AU - Wark, John D
AU - Osborne, Richard Harry
AU - Mitchell, Peter J
AU - Wriedt, Chris J
AU - Buchbinder, Rachelle
PY - 2014
Y1 - 2014
N2 - We previously reported the results of a randomized controlled trial that found no benefit of vertebroplasty over a sham procedure for acute osteoporotic vertebral fractures up to six months. We report here the 12- and 24-month clinical outcomes of this trial. Eligible participants (n?=?78) were randomly assigned to receive either vertebroplasty (n?=?38) or a sham procedure (n?=?40). Randomisation was stratified by treatment centre, sex, and symptom duration (<6 weeks or = 6 weeks). Participants, investigators (except the treating radiologists), and outcome assessors were blinded to group assignments. Enrolment occurred between April 2004 and October 2008 with follow-up completed October 2010. The primary outcome was overall pain measured on a scale of 0 (no pain) to 10 (maximal imaginable pain). Secondary outcomes included pain at rest and at night, disability, quality of life, perceived recovery and adverse events, including incident clinically apparent vertebral fractures. At 12 and 24 months, complete data were available for 67 (86 ) and 57 (73 ) participants respectively. At 12 months participants in the active group improved by 2.4 (SD 2.7) units in overall pain compared with 1.9 (SD 2.8) units in the sham group, adjusted between-group mean difference (MD) 0.3 (95 CI -0.9 to 1.5) while at 24 months participants in the active group had improved by 3.0 units (SD 3.1) compared with 1.9 units (SD 3.0) in the sham group, MD 1.1 (95 CI -0.3 to 2.4). No significant between-group differences were observed for any of the secondary efficacy outcomes at 12 or 24 months. There were no between-group differences in incident clinical vertebral fractures up to 24 months (active: N?=?14, sham: N?=?13), although the study had inadequate power for this outcome. These results provide further evidence that the use of this treatment in routine care is unsupported.
AB - We previously reported the results of a randomized controlled trial that found no benefit of vertebroplasty over a sham procedure for acute osteoporotic vertebral fractures up to six months. We report here the 12- and 24-month clinical outcomes of this trial. Eligible participants (n?=?78) were randomly assigned to receive either vertebroplasty (n?=?38) or a sham procedure (n?=?40). Randomisation was stratified by treatment centre, sex, and symptom duration (<6 weeks or = 6 weeks). Participants, investigators (except the treating radiologists), and outcome assessors were blinded to group assignments. Enrolment occurred between April 2004 and October 2008 with follow-up completed October 2010. The primary outcome was overall pain measured on a scale of 0 (no pain) to 10 (maximal imaginable pain). Secondary outcomes included pain at rest and at night, disability, quality of life, perceived recovery and adverse events, including incident clinically apparent vertebral fractures. At 12 and 24 months, complete data were available for 67 (86 ) and 57 (73 ) participants respectively. At 12 months participants in the active group improved by 2.4 (SD 2.7) units in overall pain compared with 1.9 (SD 2.8) units in the sham group, adjusted between-group mean difference (MD) 0.3 (95 CI -0.9 to 1.5) while at 24 months participants in the active group had improved by 3.0 units (SD 3.1) compared with 1.9 units (SD 3.0) in the sham group, MD 1.1 (95 CI -0.3 to 2.4). No significant between-group differences were observed for any of the secondary efficacy outcomes at 12 or 24 months. There were no between-group differences in incident clinical vertebral fractures up to 24 months (active: N?=?14, sham: N?=?13), although the study had inadequate power for this outcome. These results provide further evidence that the use of this treatment in routine care is unsupported.
UR - http://onlinelibrary.wiley.com/doi/10.1002/jbmr.2157/pdf
U2 - 10.1002/jbmr.2157
DO - 10.1002/jbmr.2157
M3 - Article
VL - 29
SP - 1346
EP - 1355
JO - Journal of Bone and Mineral Research
JF - Journal of Bone and Mineral Research
SN - 0884-0431
IS - 6
ER -