Abstract
Introduction
Teriparatide [rhPTH (1–34)] reduces fracture risk, and in a published meta-analysis of clinical trials, teriparatide-treated patients had reduced incidence of back pain relative to placebo or to antiresorptive drugs. The aim of this study was to evaluate back pain in teriparatide-treated versus comparator-treated patients during an interval including controlled clinical trials plus 30 months of additional follow-up.
Methods
A meta-analysis of four completed randomized, double-blinded trials of teriparatide [rhPTH (1–34)] versus comparator was performed. A multivariate Cox proportional hazards model was used to assess the heterogeneity of results and to estimate the relative risk of back pain.
Results
Patients in the pooled teriparatide group had reduced risk for any back pain [relative risk, 0.73 (95% CI, 0.61–0.87)], moderate or severe back pain [0.72 (0.58–0.89)], and severe back pain [0.39 (0.25–0.61)] compared with pooled controls, from initiation of the study drug through the end of follow-up. Sensitivity analysis showed that the results were robust to the removal of each individual trial from the meta-analysis. Separate meta-analyses comparing teriparatide versus placebo or antiresorptive drugs gave similar results.
Conclusions
Teriparatide-treated patients had a reduced incidence of back pain versus those receiving a comparator during an observation encompassing clinical trials plus 30 months of posttreatment observation.
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Acknowledgements
We gratefully acknowledge the assistance of Mindy Rance with the figures and Asad Rand for statistical support. Funding for this study was provided by Lilly Research Laboratories, Eli Lilly and Company.
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Nevitt, M.C., Chen, P., Kiel, D.P. et al. Reduction in the risk of developing back pain persists at least 30 months after discontinuation of teriparatide treatment: a meta-analysis. Osteoporos Int 17, 1630–1637 (2006). https://doi.org/10.1007/s00198-006-0177-z
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DOI: https://doi.org/10.1007/s00198-006-0177-z