Effect of alendronate on limited-activity days and bed-disability days caused by back pain in postmenopausal women with existing vertebral fractures. Fracture Intervention Trial Research Group.
BACKGROUND
Women with new vertebral fractures have an increased risk of back pain and functional limitation because of back pain. Alendronate sodium treatment reduces the risk of new vertebral fracture by 50% in postmenopausal women with osteoporosis.


OBJECTIVE
To determine the effect of alendronate therapy on days affected by back pain in postmenopausal women with existing vertebral fractures.


METHODS
Three-year, placebo-controlled, randomized, double-blind study.


METHODS
Fifteen university-based research clinics in the United States.


METHODS
A total of 2027 postmenopausal women aged 55 to 81 years with low femoral neck bone density and a preexisting vertebral fracture.


METHODS
Alendronate sodium (5 mg/d for 2 years and 10 mg/d for the third year) or placebo.


METHODS
Occurrence and severity of back pain, number of days with back pain, and number of days of bed rest or limited activity because of back pain during 3 years of follow-up.


RESULTS
Irrespective of treatment assignment, women with new, clinically recognized vertebral fractures during follow-up had an increased risk of days of bed disability and days of limited activity because of back pain after the fracture. Women receiving alendronate reported an average of 3.2 fewer days of bed rest (P = .001) and 11.4 fewer days of limited activity (not including days of bed rest) because of back pain (P = .04) during follow-up than those receiving placebo. In the alendronate group, relative to the placebo group, there was a reduced risk of 1 or more bed-rest days (relative risk, 0.68; 95% confidence interval, 0.53-0.87), of 7 or more bed-rest days (0.44; 0.30-0.64), and of 7 or more limited-activity days (0.87; 0.76-0.99). There were no statistically significant differences between treatment groups in the frequency of days of back pain or increases in back-related disability between baseline and study end.


CONCLUSIONS
In postmenopausal women with preexisting vertebral fracture, alendronate therapy for 3 years reduced the number of days of bed disability and days of limited activity caused by back pain.
Nevitt
M C
MC
Department of Epidemiology and Biostatistics, University of California, San Francisco 94105, USA. mnevitt@psg.ucsf.edu
Thompson
D E
DE
Black
D M
DM
Rubin
S R
SR
Ensrud
K
K
Yates
A J
AJ
Cummings
S R
SR
D000203:Activities of Daily Living; D000368:Aged; D019386:Alendronate / Q000627:therapeutic use*; D001416:Back Pain / Q000188:drug therapy* / Q000209:etiology; D001510:Bed Rest; D015519:Bone Density / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications*; D012306:Risk; D012720:Severity of Illness Index; D016103:Spinal Fractures / Q000150:complications* / Q000209:etiology*; D016896:Treatment Outcome
D019386:Alendronate