Longterm reduction of back pain risk in women with osteoporosis treated with teriparatide compared with alendronate.
OBJECTIVE
To compare the effects on back pain of teriparatide versus alendronate, we analyzed the reporting of back pain in a head to head comparator trial and a followup study.


METHODS
In the comparator trial, women were randomized to receive either daily self-injected teriparatide 40 microg plus an oral placebo (n = 73), or daily oral alendronate 10 mg plus self-injected placebo (n = 73). Treatment was for a median 14 months. After completion of the comparator trial, 72% of these patients enrolled in a nontreatment followup study. Adverse events were recorded at each comparator trial visit and followup study visit, and the incidence of new or worsening back pain in each group was compared.


RESULTS
During the comparator trial, compared with women randomized to alendronate 10 mg, women randomized to teriparatide 40 microg had reduced risk for any back pain (relative risk 0.27, 95% CI 0.09-0.82) and moderate or severe back pain (relative risk 0.19, 95% CI 0.04-0.86). The differences in the reporting of back pain between the teriparatide treated women and the alendronate treated women were sustained during an interval including the comparator trial plus 18 additional months. During an interval including the comparator trial plus 30 additional months, teriparatide treated patients had numerically fewer occurrences of back pain and moderate or severe back pain.


CONCLUSIONS
Compared with women randomized to alendronate 10 mg, women randomized to teriparatide 40 microg had reduced risk of back pain during the trial and 2.5 years of followup.
Miller
Paul D
PD
Colorado Center for Bone Research, Lakewood, 80227, USA. millerccbr@aol.com
Shergy
William J
WJ
Body
Jean-Jacques
JJ
Chen
Peiqi
P
Rohe
Mark E
ME
Krege
John H
JH
D000368:Aged; D019386:Alendronate / Q000008:administration & dosage*; D001416:Back Pain / Q000453:epidemiology* / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000453:epidemiology*; D012307:Risk Factors; D012720:Severity of Illness Index; D019379:Teriparatide / Q000008:administration & dosage*; D016896:Treatment Outcome
D019379:Teriparatide; D019386:Alendronate