Vertebral fractures are the most common
osteoporotic fracture and may result in
back pain with functional limitations and diminished quality of life.
Teriparatide [rhPTH (1-34)] has been shown to increase bone mass and reduce the risk of vertebral and other
osteoporotic fractures. The aim of this study was to evaluate the effects of
teriparatide on the risk of
back pain in patients with
osteoporosis. A systematic review of the literature was performed, and five trials were identified and included in our analyses. All trials were randomized, double-blinded, and parallel with either new vertebral fracture (n=1) or bone mineral density as the primary endpoint (n=4). Four studies were in postmenopausal women with
osteoporosis, and one was in men with idiopathic or hypogonadal
osteoporosis. Two trials were placebo controlled, two trials were
alendronate controlled, and one trial involved
teriparatide plus
hormone replacement therapy versus
hormone replacement therapy alone. Reports of
back pain, defined as new or worsened
back pain after initiating the study
drug, were obtained from adverse event databases, and the risk of
back pain was analyzed using a multivariate Cox proportional hazards model. Results were not statistically heterogeneous (P=0.60) across trials, and there were no differences between groups administered
teriparatide 20 or 40 mcg/day doses (P=0.64). The rates of
back pain, moderate or severe
back pain, and severe
back pain per 100 patient-years were numerically lower in the
teriparatide versus comparator groups in each study. Compared with the pooled comparator, patients in the pooled
teriparatide group had reduced risk for any
back pain [relative risk, 0.66 (95% CI, 0.55-0.80)], moderate or severe
back pain [relative risk, 0.60 (95% CI, 0.48-0.75)] and severe
back pain [relative risk, 0.44 (95% CI, 0.28-0.68)]. Separate meta-analyses comparing
teriparatide versus placebo or
antiresorptive drugs gave similar results. In conclusion, patients randomized to
teriparatide had a reduced risk of new or worsening
back pain compared to patients randomized to placebo,
hormone replacement therapy or
alendronate.