Sustained nonvertebral fragility fracture risk reduction after discontinuation of teriparatide treatment

Prince, Richard<sup>1</sup>; Sipos, Adrien<sup>2</sup>; Hossain, Anwar<sup>2</sup>; Syversen, Unni<sup>3</sup>; Ish-Shalom, Sophia<sup>4</sup>; Marcinowska, Ewa<sup>5</sup>; Halse, Johan<sup>6</sup>; Lindsay, Robert<sup>7</sup>; Dalsky, Gail P.<sup>2</sup>; Mitlak, Bruce H.<sup>2</sup>

Affiliations

¹Department of Endocrinology and Diabetes and University of Western Australia, Sir Charles Gairdner Hospital, Nedlands, Australia

²Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA

³Department of Endocrinology, St Olav’s University Hospital, Trondheim, Norway

⁴Metabolic Bone Diseases Unit, Rambam Medical Center, Haifa, Israel

⁵Department of Family and Internal Medicine, Warsaw, Poland

⁶Osteoporosis Clinic (Betanien Med Laboratory), Oslo, Norway

⁷Regional Bone Center, Helen Hayes Hospital, West Haverstraw, New York, USA.

Abstract and keywords

A follow-up in 1262 women was conducted after the discontinuation of teriparatide. The hazard ratio for combined teriparatide group (20 and 40 μg) for the 50-month period after baseline was 0.57 (p = 0.002), suggesting a sustained effect in reducing the risk of nonvertebral fragility fracture.

Introduction: Treatment with teriparatide {rhPTH(1-34)} 20 and 40 μg once-daily subcutaneous dosing significantly reduced the risk of nonvertebral fragility fractures over a median exposure of 19 months.

Materials and Methods: All participants in the Fracture Prevention Trial were invited to participate in a follow-up study. Prior treatment assignments were revealed, and patients were able to receive osteoporosis treatments without restriction.

Results: Approximately 60% of the 1262 patients received an osteoporosis treatment at some time during follow-up, with greater use in the former placebo group than in the combined former teriparatide group (p < 0.05). The hazard ratios for nonvertebral fragility fractures in each teriparatide group relative to placebo were statistically significant for the 50-month period including treatment and follow-up (p < 0.03). In the follow-up period, the hazard ratio was significantly different between the 40 μg and combined groups versus placebo but not for the 20 μg group versus placebo. However, the 20 and 40 μg groups were not different from each other. Kaplan-Meier analysis of time to fracture showed that the fracture incidence in the former placebo and teriparatide groups diverged during the 50-month period including teriparatide treatment and follow-up (p = 0.009). Total hip and femoral neck BMD decreased in teriparatide-treated patients who had no follow-up treatment; BMD remained stable or further increased in patients who received a bisphosphonate after teriparatide treatment.

Conclusions: While the study design is observational, the results support a sustained effect of teriparatide in reducing the risk of nonvertebral fragility fractures up to 30 months after discontinuation of treatment.

Keywords: teriparatide; postmenopausal osteoporosis; nonvertebral fracture; BMD; osteoporosis treatment

Links

DOI: 10.1359/JBMR.050501

PubMed: 16059622

WoS: 000231490200002

History

Received: 2004-12-06

Revised: 2005-04-06

Accepted: 2005-04-27

Online: 2005-05-02

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