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Response of bone turnover markers to raloxifene treatment in postmenopausal women with osteopenia

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Abstract

Summary

We used two methods of identifying women who reached the target for raloxifene treatment with bone turnover markers. Both approaches identified women that responded to treatment but did not fully agree and may be complementary.

Introduction

The change in bone turnover markers (BTMs) in response to osteoporosis therapy can be assessed by a decrease beyond the least significant change (LSC) or below the mean of the reference interval (RI). We compared the performance of these two approaches in women treated with raloxifene.

Methods

Fifty postmenopausal osteopenic women (age 51–72 years) were randomised to raloxifene or no treatment for 2 years. Blood samples were collected for the measurement of BTM. The LSC for each marker was calculated from the untreated women and the RI obtained from healthy premenopausal women (age 35–40 years). Bone mineral density (BMD) was measured at the spine and hip.

Results

There was a decrease in BTM in response to raloxifene treatment, percentage change at 12 weeks: C terminal telopeptide of type I collagen (CTX) −39 % (95 % CI −48 to −28) and N terminal propeptide of type I procollagen (PINP) −32 % (95 % CI −40 to −23) P < 0.001. The proportion of women classified as responding to treatment using LSC at 12 weeks was as follows: CTX 38 % and PINP 52 % and at 48 weeks CTX 60 % and PINP 65 %. For the RI approach, the proportion of women classified as responding to treatment at 12 weeks was CTX and PINP 38 % and at 48 weeks CTX 40 % and PINP 45 %. There was a significant difference in the change in spine BMD in the raloxifene-treated group compared to the no-treatment group at week 48: difference 0.031 g/cm2 (95 % CI 0.016 to 0.046, P < 0.001).

Conclusions

The two approaches identified women that reached the target for treatment using BTM. Both LSC and RI criteria appear useful in identifying treatment response, but the two approaches do not fully overlap and may be complementary.

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Acknowledgments

This work was supported by Eli Lilly Pharmaceuticals, UK (clinical study), and Immunodiagnostic Systems, UK (providing reagents for iSYS assays).

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Authors and Affiliations

  1. Academic Unit of Bone Metabolism, The Mellanby Centre for Bone Research, University of Sheffield, Sheffield, UK

    K. E. Naylor, F. Gossiel & R. Eastell

  2. School of Health and Related Research, University of Sheffield, Sheffield, UK

    R. M. Jacques

  3. Metabolic Bone Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital Sheffield, Sheffield, UK

    N. F. A. Peel

Authors
  1. K. E. Naylor
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  2. R. M. Jacques
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  3. N. F. A. Peel
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  4. F. Gossiel
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  5. R. Eastell
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Corresponding author

Correspondence to K. E. Naylor.

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Conflicts of interest

Dr Naylor, Miss Gossiel and Dr Jacques have no disclosures. Dr N Peel has received speaker’s honoraria and funding to attend educational events from Warner Chilcott, Lilly, Servier, Merck, Roche, GSK and ProStrakan and consultancy fees from Internis Pharma, ProStrakan and Lilly. Professor Eastell has received funding from the National Institute for Health research (NIHR) and grant/consultancy funding from Warner Chilcott, Eli Lilly, Roche, Immunodiagnostic Systems and Merck.

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Naylor, K.E., Jacques, R.M., Peel, N.F.A. et al. Response of bone turnover markers to raloxifene treatment in postmenopausal women with osteopenia. Osteoporos Int 27, 2585–2592 (2016). https://doi.org/10.1007/s00198-016-3573-z

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  • DOI: https://doi.org/10.1007/s00198-016-3573-z

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