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Early Effects of Raloxifene on Clinical Vertebral Fractures at 12 Months in Postmenopausal Women With Osteoporosis
Michael Maricic, MD;
Jonathan D. Adachi, MD;
Somnath Sarkar, PhD;
Wentao Wu, MS;
Mayme Wong, PhD;
Kristine D. Harper, MD
Arch Intern Med. 2002;162:1140-1143.
Background Raloxifene hydrochloride therapy reduces the risk for vertebral fractures
at 3 years, but the effects on clinical vertebral fractures in the first year
are not known.
Methods The Multiple Outcomes of Raloxifene Evaluation (MORE) Trial enrolled
7705 women with osteoporosis, defined by prevalent vertebral fractures and/or
a bone mineral density (BMD) T score at or below -2.5, who were treated
with placebo or raloxifene at a dosage of 60 or 120 mg/d for 3 years. New
clinical vertebral fractures were defined as incident vertebral fractures
associated with signs and symptoms suggestive of vertebral fractures, such
as back pain, and were diagnosed by means of postbaseline adjudicated spinal
radiographs. Scheduled spinal radiographs were obtained at baseline and at
2 and 3 years. In addition, unscheduled spinal radiographs were obtained in
women who reported signs or symptoms suggestive of vertebral fracture, and
these radiographs subsequently underwent adjudication. If an adjudicated fracture
was identified, this was also considered a clinical fracture.
Results At 1 year, raloxifene, 60 mg/d, decreased the risk for new clinical
vertebral fractures by 68% (95% confidence interval [CI], 20%-87%) compared
with placebo in the overall study population, and by 66% (95% CI, 23%-89%)
in women with prevalent vertebral fractures, who are at greater risk for subsequent
fracture. The risk for clinical vertebral fractures in the raloxifene, 60
mg/d, group was decreased by 46% (95% CI, 14%-66%) at 2 years and by 41% (95%
CI, 17%-59%) at 3 years. The cumulative incidence of new clinical vertebral
fractures was lower in the group receiving raloxifene, 60 mg/d, compared with
placebo (P<.001). We found no significant differences
in the risk reductions for clinical vertebral fractures between the raloxifene
groups at 1, 2, or 3 years.
Conclusion The early risk reduction for new clinical vertebral fractures with 1
year of raloxifene treatment was similar to that reported with other antiresorptive
agents.
From the Section on Rheumatology, Department of Medicine, Southern
Arizona Veterans Affairs Health Care System, Tucson (Dr Maricic); Department
of Rheumatology, St Joseph's Hospital, McMaster University, Hamilton, Ontario
(Dr Adachi); and Lilly Research Laboratories, Eli Lilly and Company, Indianapolis,
Ind (Drs Sarkar, Wong, and Harper and Mr Wu). Dr Maricic has received research
funding for conducting clinical trials, has received honoraria for serving
as a speaker, has served as a paid consultant, and is on the scientific advisory
board for Eli Lilly and Company.
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