Effects of raloxifene on fracture risk in postmenopausal women: the Raloxifene Use for the Heart Trial.
Using data from a randomized placebo-controlled trial of 10,101 postmenopausal women not selected on the basis of osteoporosis, we examined whether the effect of raloxifene treatment on fractures was consistent across categories of fracture risk. Treatment with raloxifene for 5 yr reduced the risk of clinical vertebral fractures, but not nonvertebral fractures, irrespective of the presence or absence of risk factors for fracture.


BACKGROUND
In The Raloxifene Use for The Heart (RUTH) trial, women assigned to raloxifene had a lower risk of clinical vertebral fractures but not nonvertebral fractures. However, it is uncertain whether the effect of raloxifene on fractures in this population not selected for low BMD differs according to risk factors for fractures.


METHODS
We randomly assigned 10,101 postmenopausal women >or=55 yr of age with documented coronary heart disease or at high risk for coronary events to 60 mg raloxifene daily or placebo and followed them for a median of 5.6 yr. Fractures (nonvertebral and clinical vertebral) were prespecified secondary endpoints that were reported at semiannual visits. Fractures were adjudicated and confirmed using X-ray reports or medical records.


RESULTS
There was no difference between raloxifene and placebo groups in risk of nonvertebral fractures (428 versus 438 events; hazard ratio [HR], 0.96; 95% CI, 0.84-1.10), including hip/femur (89 versus 103 events; HR, 0.85; 95% CI, 0.64-1.13) and wrist (107 versus 111 events; HR, 0.95; 95% CI, 0.73-1.24) fractures. Women treated with raloxifene had a lower risk of clinical vertebral fractures (64 versus 97 events; HR, 0.65; 95% CI, 0.47-0.89). The effect of treatment with raloxifene on risk of nonvertebral and clinical vertebral fractures was consistent across fracture risk categories defined at baseline by age, smoking status, physical activity level, prior history of fracture, family history of hip fracture, diabetes mellitus, previous use of hormone therapy, thyroid hormone use, statin use, weight loss, body mass index, or fracture specific summary risk score.


CONCLUSIONS
In older women with or at high risk of coronary heart disease not selected on the basis of osteoporosis or increased fracture risk, treatment with raloxifene for 5 yr reduced the risk of clinical vertebral fractures, but not nonvertebral fractures, irrespective of presence or absence of risk factors for fracture.
Ensrud
Kristine E
KE
Center for Chronic Disease Outcomes Research, Veterans Affairs Medical Center, Minneapolis, Minnesota, USA. ensru001@.umn.edu
Stock
John L
JL
Barrett-Connor
Elizabeth
E
Grady
Deborah
D
Mosca
Lori
L
Khaw
Kay-Tee
KT
Zhao
Qingwen
Q
Agnusdei
Donato
D
Cauley
Jane A
JA
D000368:Aged; D003327:Coronary Disease / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D050723:Fractures, Bone / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D017698:Postmenopause; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D012306:Risk; D016103:Spinal Fractures / Q000453:epidemiology / Q000517:prevention & control
D020849:Raloxifene Hydrochloride