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Relationship between duration of teriparatide therapy and clinical outcomes in postmenopausal women with osteoporosis

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Abstract

Summary

The extent to which fracture protection and safety varies with increasing time on teriparatide [rhPTH(1-34)] therapy is a clinically relevant unanswered question. In postmenopausal women with osteoporosis, increased duration of teriparatide versus placebo treatment was associated with a progressive decrease in the rates of nonvertebral fragility fractures and back pain.

Introduction

The impact of duration of teriparatide [rhPTH(1-34)] therapy on patient outcomes is a relevant unanswered question.

Methods

Postmenopausal women with osteoporosis were randomized to once-daily subcutaneous injection with placebo (N = 544), teriparatide 20 µg (TPTD20; N = 541), or teriparatide 40 µg (TPTD40; N = 552) plus calcium and vitamin D supplementation. The time to first nonvertebral fragility fracture and new or worsening back pain following treatment initiation was analyzed using Cox partial likelihood regression treating time on therapy as a linear, time-dependent covariate.

Results

Compared with placebo, the relative hazard for nonvertebral fragility fractures decreased by 7.3% for each additional month of TPTD20 [hazard ratio = 0.927, 95% CI (0.876 to 0.982), p = 0.009] and by 7.6% for each additional month of TPTD40 [hazard ratio = 0.924, 95% CI (0.871 to 0.981), p = 0.009]. Clinical vertebral fractures appeared to increase over time in the placebo group and occurred primarily in the first time interval in the teriparatide treatment groups. Compared with placebo, the relative hazard of back pain was decreased by 8.3% for each additional month of TPTD20 [hazard ratio = 0.920, 95% CI (0.902 to 0.939), p < 0.001] and 8.7% for each additional month of TPTD40 [hazard ratio = 0.917, 95% CI (0.898 to 0.935), p < 0.001].

Conclusions

These findings suggest increased nonvertebral fracture protection, reduced back pain, and reduced occurrence of side effects with longer duration of teriparatide therapy.

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Acknowledgements

The authors are grateful for the assistance of Melinda Rance, BS, in the preparation of the figures, and Jahangir Alam, MS, and Kathryn Engstrom, BS, for assistance with programming the statistical analyses. We thank Jingyuan Wang, PhD, and Erik F. Eriksen, DMSc, MD, for contributions to the design of the study and critical review of earlier drafts of the manuscript. This work was sponsored by Lilly Research laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.

Conflicts of interest

Funding was provided by Eli Lilly and Company. Drs. Pohl, Glass, Chen and Krege are employees of Eli Lilly and Company.

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Authors and Affiliations

  1. Helen Hayes Hospital, West Havershaw, NY, USA

    R. Lindsay

  2. University of Colorado Health Sciences Center, Denver, and Colorado Center for Bone Research, Lakewood, CO, USA

    P. Miller

  3. Eli Lilly and Company, Lilly Corporate Center, Drop Code 6134, Indianapolis, IN, 46285, USA

    G. Pohl, E. V. Glass, P. Chen & J. H. Krege

Authors
  1. R. Lindsay
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  2. P. Miller
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  3. G. Pohl
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  4. E. V. Glass
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  5. P. Chen
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  6. J. H. Krege
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Corresponding author

Correspondence to J. H. Krege.

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Lindsay, R., Miller, P., Pohl, G. et al. Relationship between duration of teriparatide therapy and clinical outcomes in postmenopausal women with osteoporosis. Osteoporos Int 20, 943–948 (2009). https://doi.org/10.1007/s00198-008-0766-0

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  • DOI: https://doi.org/10.1007/s00198-008-0766-0

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