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Reduction of Hip and Other Fractures in Patients Receiving Teriparatide in Real-World Clinical Practice: Integrated Analysis of Four Prospective Observational Studies

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Abstract

The phase 3 teriparatide Fracture Prevention Trial showed significant reductions in vertebral (VF) and nonvertebral (NVF) fractures; however, patient exposure was insufficient for full analysis of low-incidence fractures, including hip. We assessed fracture results in pooled data from four prospective, observational teriparatide studies. Ambulatory women and men with osteoporosis received subcutaneous teriparatide 20 µg/day for up to 24 months per routine clinical practice. Fracture rates were compared between 6-month periods, using 0 to 6 months of treatment as the reference period. Analyses used a piecewise exponential model for first fracture. Hip, NVF, clinical VF (CVF), any clinical, and wrist fractures were assessed. For 8828 patients analyzed, mean age was 71 years; mean (SD) treatment duration was 17.4 (8.6) months. The rate of hip fracture decreased significantly for the > 12 to 18-month (− 47.7%) and > 18-month periods (-85.2%) versus the first 6 months of therapy, and for the > 18 versus the > 6 to 12-month period. NVF, CVF, and all clinical fractures were all significantly decreased in each post-reference period, with maximum decreases (> 18-month period) of 52.7%, 69.4%, and 61.2%, respectively, versus 0 to 6 months. No significant reduction was seen for rates of wrist fracture. Teriparatide treatment was associated with statistically significant decreases in hip fracture rate, particularly for > 18 months of treatment, and in NVF, CVF, and all clinical fracture rate in real-world patients. These results should be interpreted in the context of the non-controlled design of the source studies.

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Author information

Authors and Affiliations

  1. Cedars-Sinai Medical Center, David Geffen School of Medicine, UCLA, and OMC Clinical Research Center, 8641 Wilshire Blvd, Suite 301, Beverly Hills, CA, 90211, USA

    Stuart Silverman

  2. Arhus University Hospital, Aarhus, Denmark

    Bente L. Langdahl

  3. Department of Pharmacy, Yasuda Women’s University, Hiroshima, Japan

    Saeko Fujiwara

  4. University of Alabama at Birmingham, Birmingham, AL, USA

    Ken Saag

  5. University Campus Bio-Medico, Rome, Italy

    Nicola Napoli

  6. Department of Orthopaedic Surgery and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan

    Satoshi Soen

  7. Eli Lilly Japan K.K., Kobe, Japan

    Hiroyuki Enomoto

  8. Syneos Health, Raleigh, NC, USA

    Thomas E. Melby

  9. Eli Lilly and Company, Indianapolis, IN, USA

    Damon P. Disch & John H. Krege

  10. Lilly Research Centre, Windlesham, UK

    Fernando Marin

  11. Istituto Ortopedico Galeazzi, Milan, Italy

    Nicola Napoli

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  1. Stuart Silverman
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  2. Bente L. Langdahl
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  3. Saeko Fujiwara
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  4. Ken Saag
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  5. Nicola Napoli
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  6. Satoshi Soen
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  7. Hiroyuki Enomoto
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  8. Thomas E. Melby
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  9. Damon P. Disch
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  10. Fernando Marin
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  11. John H. Krege
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Corresponding author

Correspondence to Stuart Silverman.

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Conflict of interest

S.S. is on the Speaker’s Bureau and is a consultant for and has received research support from Eli Lilly and Co.; K.S. has received consultant fees and has research Grants from Eli Lilly and Co.; B.L.L. has received fees for serving on advisory boards, speaking at symposia, and has received research grants from Eli Lilly and Co. Amgen, UCB, Merck, and Novo Nordisk; NN has received consultant and speaker fees from Eli Lilly and Co.; S.F. and S.S. have nothing to declare; T.E.M. is an employee of Syneos Health under contract to Eli Lilly and Co.; D.P.D., F.M., H.E., and J.H.K. are employees of Eli Lilly and Co.

Ethical Approval

The studies analyzed herein were approved by local ethics committees or review boards, depending on local requirements, and were conducted in compliance with all applicable laws, regulations and guidelines.

Human and Animal Rights and Informed Consent

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Written informed consent was obtained from all individual patients included in the study.

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Silverman, S., Langdahl, B.L., Fujiwara, S. et al. Reduction of Hip and Other Fractures in Patients Receiving Teriparatide in Real-World Clinical Practice: Integrated Analysis of Four Prospective Observational Studies. Calcif Tissue Int 104, 193–200 (2019). https://doi.org/10.1007/s00223-018-0485-2

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  • DOI: https://doi.org/10.1007/s00223-018-0485-2

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