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The effect of teriparatide compared with risedronate on reduction of back pain in postmenopausal women with osteoporotic vertebral fractures

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Abstract

Summary

The effect of teriparatide and risedronate on back pain was tested, and there was no difference in the proportion of patients experiencing a reduction in back pain between groups after 6 or 18 months. Patients receiving teriparatide had greater increases in bone mineral density and had fewer vertebral fractures.

Introduction

This study aimed to understand the effect of teriparatide in reducing back pain in patients with prevalent back pain and vertebral fracture compared to risedronate.

Methods

In an 18-month randomized, double-blind, double-dummy trial, we investigated the effects of teriparatide (20 μg/day) vs. risedronate (35 mg/week) in postmenopausal women with back pain likely due to vertebral fracture. The primary objective was to compare the proportion of subjects reporting ≥30% reduction in worst back pain severity from baseline to 6 months as assessed by a numeric rating scale in each treatment group. Pre-specified secondary and exploratory outcomes included assessments of average and worst back pain at additional time points, disability and quality of life, bone mineral density, incidence of fractures, and safety.

Results

At 6 months, 59% of teriparatide and 57% of risedronate patients reported ≥30% reduction in worst back pain and there were no differences between groups in the proportion of patients experiencing reduction in worst or average back pain at any time point, disability, or quality of life. There was a greater increase from baseline in bone mineral density at the lumbar spine (p = 0.001) and femoral neck (p = 0.02) with teriparatide compared to risedronate and a lower incidence of vertebral fractures at 18 months (4% teriparatide and 9% risedronate; p = 0.01). Vertebral fractures were less severe (p = 0.04) in the teriparatide group. There was no difference in the overall incidence of adverse events.

Conclusions

Although there were no differences in back pain-related endpoints, patients receiving teriparatide had greater skeletal benefit than those receiving risedronate.

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Acknowledgments

This study was funded by Eli Lilly and Company. We thank Deborah Gold, Li Xie (Lilly employee and stockholder), Fernando Marin (Lilly employee and stockholder), and Donato Agnusdei (Lilly employee and stockholder) for their contributions to the study design; Sandra Walker (Lilly employee and stockholder), Erin Strouse (Lilly employee and stockholder), Valerie Ruff (Lilly employee and stockholder), Ewa Rogos (Lilly employee and stockholder), Beatriz Sans (Lilly employee and stockholder), Nadine Baker (Lilly employee and stockholder), and Joanne Lorraine (Lilly employee and stockholder) for their efforts in study management; and Mark Rohe (Lilly employee and stockholder), Hassan Jamal (Lilly employee and stockholder), David Shrom (Lilly employee and stockholder), and Gail Dalsky (Lilly employee and stockholder) for their technical assistance and writing support.

Contributing investigators include: Argentina: J.R. Zanchetta, Z. Man, E.M. Kerzberg, M.A. Lazaro, E.F. Mysler, and L. Naftal; Australia: A.P. Roberts, S. Hall, J. Eden, T. Diamond, and P. Nash; Belgium: S. Boonen, J.-M. Kaufman, Y. Bousten, M. Malaise, and M. De Meulemeester; Brazil: L. Russo, J. Neto, and R. Pereira; Canada: J. Adachi, A. Hodsman, R. Kremer, W.Olszynski, J.-L. Trembly, C. Yuen, D.L. Kendler, and J. Brown; France: C. Roux, M. De Vernejoul, P. Fardellone, L. Benhamou, F. Debiais, and C. Cormier; Germany: P. Hadji, F. Thomasius, J. Krug, P. Kaps, I. Frieling, C. Kasperk, C. Niedhart, and H. Radspieler; Italy: R. Nuti, S. Adami, and G. Resmini; Mexico: P. Garcia-Hernandez, J. Morales-Torres, J. Tamayo y Orozco, and R. Correa-Rotter; Spain: J. Del Pino, M. Munoz Torres, J. Roman Ivorra, C. Lozano Tonkin, M. Diaz Curiel, and E. Martin Mola; Sweden: O. Ljunggren, Y. Pernow, A. Ramnemark, and U.-B. Ericsson; USA: S. Broy, A. Myers, R. Leon, M. Econs, F. McKiernan, C. Recknor, T. Rooney, C. Ronkar, K. Saag, E. Schwartz, A. Sebba, O. Soto, G. Woodson, R. Feldman, J. Jakes, R. Recker, W. Saikali, J. Schechtman, N. Binkley, C. Deal, A. Abelson, L. Kohlmeier, and R. Sierra-Zorita.

Conflicts of interest

P. Hadji was a recipient of a grant/research support from Eli Lilly and Company, Procter & Gamble; speakers bureau with Eli Lilly and Company (Lilly) and Procter & Gamble; advisory board membership of Lilly and Procter & Gamble; consulting fees from Lilly and Procter & Gamble; lecture fees from Lilly and Procter & Gamble; and speaker fees from Lilly and Procter & Gamble.

J. Zanchetta received an advisory board membership of Lilly, Amgen, GlaxoSmithKline, Merck, Pfizer, and Servier and consulting fees from Lilly, Amgen, GlaxoSmithKline, Merck, Pfizer, and Servier.

C. Recknor received an advisory board membership of Lilly, Zelos, Takeda, and Novartis; consulting fees from Lilly, Zelos, Takeda, and Novartis; and lecture fees from Amgen and Novartis.

K. Saag was a recipient of a grant/research support from Lilly, Novartis, GlaxoSmithKline, Sanofi Aventis, and Procter & Gamble; speakers bureau with Novartis; and consulting fees from Lilly, Novartis, Merck, Procter & Gamble, Aventis, and Amgen.

F. McKiernan received consulting fees from Lilly and Amgen.

S. Silverman was a recipient of a grant/research support from Alliance for Better Bone Health, Lilly, Pfizer; speakers bureau with Amgen, Lilly, Pfizer, and Roche Pharmaceuticals; consulting fees from Amgen, Lilly, Novartis, Pfizer, Roche Pharmaceuticals, Roche Diagnostics, and Warner Chilcott.

J. Alam, R. Burge, J. Krege, M. Lakshmanan, D. Masica, B. Mitlak, and J. Stock were shareholders and employees of Lilly.

Author information

Authors and Affiliations

  1. Department of Endocrinology, Osteoporosis, and Reproductive Medicine, Philipps-University of Marburg, Marburg, Germany

    P. Hadji

  2. IDIM, Buenos Aires, Argentina

    J. R. Zanchetta

  3. CCBR Brazil Clinical Research Center, Rio de Janeiro, Brazil

    L. Russo

  4. United Osteoporosis Centers, Gainesville, GA, USA

    C. P. Recknor

  5. University of Alabama, Birmingham, AL, USA

    K. G. Saag

  6. Center for Bone Disease, Marshfield Clinic, Marshfield, WI, USA

    F. E. McKiernan

  7. Cedars-Sinai/UCLA and OMC Clinical Research Center, Beverly Hills, CA, USA

    S. L. Silverman

  8. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

    J. Alam, R. T. Burge, J. H. Krege, M. C. Lakshmanan, D. N. Masica, B. H. Mitlak & J. L. Stock

  9. Klinik für Gynäkologie, Gynäkologische Endokrinologie und Onkologie, Leiter des Schwerpunkts Gynäkologische Endokrinologie, Reproduktionsmedizin und Osteologie, Universitätsklinikum Giessen und Marburg GmbH, Standort Marburg, Baldingerstrasse, 35033, Marburg, Germany

    P. Hadji

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  1. P. Hadji
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Correspondence to P. Hadji.

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Hadji, P., Zanchetta, J.R., Russo, L. et al. The effect of teriparatide compared with risedronate on reduction of back pain in postmenopausal women with osteoporotic vertebral fractures. Osteoporos Int 23, 2141–2150 (2012). https://doi.org/10.1007/s00198-011-1856-y

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