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Parathyroid Hormone(1–84) Treatment of Postmenopausal Women with Low Bone Mass Receiving Hormone Replacement Therapy

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Abstract

Treatment of postmenopausal osteoporosis (PMO) is based primarily on antiresorptive agents, including hormone replacement therapy (HT). To evaluate whether anabolic therapy together with HT provides additional benefits in the treatment of PMO, we evaluated the effects of parathyroid hormone (PTH) 1–84 in postmenopausal women with low bone mineral density (BMD) who were receiving chronic (≥6 months) HT. Subjects were randomized to receive 100 μg PTH(1–84) or placebo injections daily for 24 months (n = 90/group). The primary efficacy outcome was change from baseline in lumbar spine BMD. Secondary end points included changes in hip and distal radius BMD, bone turnover markers, and fracture incidence. The study was terminated early following recommendations regarding HT for PMO. At 18 months, the mean increase in lumbar spine BMD was 7.9% for PTH(1–84) subjects vs. 1.5% for those receiving HT alone; between-group differences were significant at 6 months and persisted throughout the study. Lumbar spine BMD increased in 94% of women receiving PTH(1–84) compared to 59% for HT alone. Femoral neck BMD and bone turnover markers were significantly higher in PTH(1–84)-treated subjects, but the changes in total hip and distal radius BMD were not significant. PTH(1–84) treatment was generally well-tolerated, with hypercalciuria, hypercalcemia, nausea, vomiting, and dizziness reported more frequently in the HT + PTH(1–84) group. In conclusion, addition of PTH(1–84) to stable HT produced marked increases in lumbar spine BMD and may represent an additional approach to the treatment of PMO women receiving HT.

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Acknowledgements

We thank all the POWER study investigators and the women who participated in this study. We also thank Anna Metcalfe, James Heusner, Tim Considine, and Jennifer Lopansri for their valuable contributions to the design and conduct of the study and Annette Mathisen and Jay Yang, who provided expert statistical analysis. This study was sponsored and funded by NPS Pharmaceuticals, Inc.

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Authors and Affiliations

  1. Guy’s, King’s and St. Thomas’ School of Medicine, St. Thomas Street, London, SE1 9RT, UK

    I. Fogelman

  2. The James Cook University Hospital, Marton Road, Middlesbrough, TS4 3BW, UK

    J. N. Fordham

  3. Royal Liverpool University Hospital, Daulby Street, Liverpool, L69 3GA, UK

    W. D. Fraser

  4. St. Thomas’ Hospital, Lambeth Palace Road, London, SE1 7EH, UK

    T. D. Spector

  5. Nordic Bioscience, Herlev Hovedgade 207, 2730, Herlev, Denmark

    C. Christiansen

  6. NPS Pharmaceuticals, 550 Hills Drive, Bedminster, NJ, 07921, USA

    S. A. Morris & J. Fox

Authors
  1. I. Fogelman
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  2. J. N. Fordham
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  3. W. D. Fraser
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  4. T. D. Spector
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  5. C. Christiansen
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  6. S. A. Morris
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  7. J. Fox
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Correspondence to J. Fox.

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Fogelman, I., Fordham, J.N., Fraser, W.D. et al. Parathyroid Hormone(1–84) Treatment of Postmenopausal Women with Low Bone Mass Receiving Hormone Replacement Therapy. Calcif Tissue Int 83, 85–92 (2008). https://doi.org/10.1007/s00223-008-9152-3

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  • DOI: https://doi.org/10.1007/s00223-008-9152-3

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