Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: four-year results from a randomized clinical trial.
The Multiple Outcomes of Raloxifene Evaluation trial studied 7705 postmenopausal women with osteoporosis randomized to placebo, or raloxifene 60 or 120 mg/d [JAMA 282(1999): 637]. This report assesses the efficacy of raloxifene on the long-term cumulative incidence new vertebral fractures through 4 yr. New vertebral fractures was assessed from radiographs taken at baseline, yr 2-4. The primary analysis was the cumulative incidence of new vertebral fractures through 4 yr. A posthoc analysis compared the vertebral fracture risk in yr 4 alone with that observed in the first 3 yr. The 4-yr cumulative relative risks (RR) for one or more new vertebral fractures were 0.64 [95% confidence interval (CI) 0.53, 0.76] with raloxifene 60 mg/d and 0.57 (95% CI 0.48, 0.69) with raloxifene 120 mg/d. In yr 4 alone, raloxifene 60 mg/d reduced the new vertebral fracture risk by 39% [RR 0.61 (95% CI 0.43, 0.88)], which was not found to be significantly different from the RR observed in the first 3 yr in both raloxifene groups, irrespective of prevalent fracture status. The nonvertebral fracture risk was not significantly reduced [RR 0.93 (95% CI 0.81, 1.06)]. The safety profile after 4 yr was similar to that observed after 3 yr. Raloxifene 60 and 120 mg/d through 4 yr decreased the cumulative risk of new vertebral fractures in postmenopausal women with osteoporosis. The decreased vertebral fracture risk in yr 4 alone was not different from that observed in the first 3 yr.
Delmas
Pierre D
PD
University of Claude Bernard of Lyon, Hôpital Edouard Herriot, Service de Rhumatologie et de Pathologie Osseuse, Lyon 69437, France. delmas@lyon151.inserm.fr
Ensrud
Kristine E
KE
Adachi
Jonathan D
JD
Harper
Kristine D
KD
Sarkar
Somnath
S
Gennari
Carlo
C
Reginster
Jean-Yves
JY
Pols
Huibert A P
HA
Recker
Robert R
RR
Harris
Steven T
ST
Wu
Wentao
W
Genant
Harry K
HK
Black
Dennis M
DM
Eastell
Richard
R
D000368:Aged; D015519:Bone Density / Q000187:drug effects; D001842:Bone and Bones / Q000187:drug effects / Q000378:metabolism; D004965:Estrogen Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000453:epidemiology*; D017698:Postmenopause; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage* / Q000009:adverse effects; D012307:Risk Factors; D016103:Spinal Fractures / Q000453:epidemiology* / Q000517:prevention & control; D016896:Treatment Outcome
D004965:Estrogen Antagonists; D020849:Raloxifene Hydrochloride