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Patients with prior vertebral or hip fractures treated with teriparatide in the Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) observational study

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Abstract

Summary

In patients in the Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) observational study with and without a prior vertebral or hip fracture, the incidence of nonvertebral fractures was lower with >6 months of teriparatide treatment than during the first 6 months.

Introduction

Clinical evidence on the effect of teriparatide in patients with prior fracture is limited. In the DANCE observational study, the incidence of nonvertebral fragility fractures (NVFX) decreased significantly in patients receiving teriparatide for >6 months (6–24 months) versus >0 to ≤6 months (reference period).

Methods

We performed a post hoc analysis to assess the effect of teriparatide 20 μg/day in patients who entered DANCE with prior vertebral or hip fractures. The incidence of patients experiencing a NVFX for four 6-month intervals during and after treatment was compared with the reference period.

Results

Overall, 4085 patients received ≥1 dose of teriparatide. Of 3720 with sufficient data for efficacy analysis, 692 had prior vertebral fracture, including 179 with previous kyphoplasty/vertebroplasty; 290 had prior hip fracture. These patients were older, and those with prior vertebral fractures had more comorbid conditions at baseline than those without prior vertebral fractures. The incidence of patients experiencing NVFX declined over time in all patient groups. The fracture incidence rate declined 49 and 46 %, respectively, in patients with and without prior vertebral fracture and was 63 and 46 % lower in patients with previous kyphoplasty/vertebroplasty and without prior vertebral fracture. NVFX declined 43 and 48 % in patients with and without prior hip fracture. The reduced incidence over time was consistent in the subgroups (all interaction p values >0.05). Patients with prior fracture were more likely to experience serious adverse events.

Conclusion

The incidence of NVFX decreased over time in patients receiving teriparatide in DANCE regardless of prior fracture status.

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Acknowledgments

This work was sponsored by Eli Lilly and Company. The authors wish to thank Eileen R. Gallagher, a full-time employee of inVentiv Health Clinical, for writing assistance, which was funded by Eli Lilly. The authors also wish to thank Kathleen A. Taylor, PhD, of Eli Lilly, for her review and feedback on the manuscript and for her contributions to the success of the DANCE study.

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Authors and Affiliations

  1. Clinical Radiology of Oklahoma, 1800 S. Renaissance Blvd, Edmond, OK, 73013, USA

    D. P. Beall

  2. Senior Clinical Trials, Inc., 23961 Calle de la Magdalena Suite 429, Laguna Hills, CA, 92653, USA

    R. G. Feldman

  3. Newport Orthopedic Institute, Newport Beach 22 Corporate Plaza Drive, Newport Beach, CA, 92660, USA

    M. L. Gordon

  4. Long Island Regional Arthritis and Osteoporosis Care, PC, 500 West Main Street, Suite 110, Babylon, NY, 11702, USA

    B. L. Gruber

  5. Hospital for Special Surgery, Weill Cornell Medical College, Ground Floor 523 East 72nd Street, New York, NY, 10021, USA

    J. M. Lane

  6. Integral Rheumatology & Immunology Specialists, 140 SW 84th Avenue, Fort Lauderdale, FL, 33324, USA

    G. Valenzuela

  7. UC Irvine Medical Center, 101 The City Drive South, Route 140, Orange, CA, 92868, USA

    D. Yim

  8. Lilly USA, LLC, Indianapolis, IN, 46285, USA

    J. Alam, J. H. Krege & K. Krohn

Authors
  1. D. P. Beall
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  2. R. G. Feldman
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  3. M. L. Gordon
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  4. B. L. Gruber
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  5. J. M. Lane
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  6. G. Valenzuela
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  7. D. Yim
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  8. J. Alam
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  9. J. H. Krege
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  10. K. Krohn
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Corresponding author

Correspondence to K. Krohn.

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Conflicts of interest

D.B. is a consultant for Medtronic, DFINE, Osseon, Lilly, Smith & Nephew, Vertiflex, Synthes, Alphatec Spine, Benvenue Medical, ConvaTec, Integral Spine Solutions, Medical Metrics, Zyga, Liventa, Amendia, Spineology, Xten, Ascendx Spine, DePuy, Johnson and Johnson, Orthovita, Vitacare, Ortho Kinematics, Advanced Technologies and Regenerative Medicine, Algea-Globus, Bone Support, and Spinal Ventures and has received funding from Medtronic, Alphatec Spine, Benvenue Medical, Liventa, and Zyga.

R.G.F. has served on the advisory board and is an investigator for Lilly.

M.L.B. has received renumeration from Eli Lilly, has served as a consultant to Globus and Lilly, and owns stock in AstraZeneca and GlaxoSmithKline.

B.L.G. has served on the Speaker’s Bureau for Lilly, Amgen, Questcor, Janssen, and Genentech and served on an advisory panel for Merck and Questcor.

J.M.L. owns stock in Graftys and CollPlant.

G.V. has served as a consultant for Janssen, Lilly, AbbVie, Questcor, Amgen, and Crealta.

D.Y. has no conflicts to disclose.

J.A. is an employee of Lilly USA, LLC and owns stock in the company; J.H.K. and K.K. are employees of Eli Lilly and Company and or/one of its subsidiaries and own stock in the company.

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Beall, D.P., Feldman, R.G., Gordon, M.L. et al. Patients with prior vertebral or hip fractures treated with teriparatide in the Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) observational study. Osteoporos Int 27, 1191–1198 (2016). https://doi.org/10.1007/s00198-015-3353-1

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  • DOI: https://doi.org/10.1007/s00198-015-3353-1

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