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The safety and effectiveness profile of daily teriparatide in a prospective observational study in Japanese patients with osteoporosis at high risk for fracture: interim report

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Abstract

This postmarketing surveillance study assessed the safety and effectiveness of daily teriparatide treatment in patients with osteoporosis in a Japanese clinical setting. In this prospective, multicenter, observational study, patients with osteoporosis at high risk for fracture received subcutaneous injections of teriparatide (20 μg/day) for a maximum of 24 months. For this interim report, data from 1,671 patients were eligible for analysis at the cutoff date. The mean age was 75.3 years; 93 % of patients (1,552/1,671 patients) were women. There were 117 adverse drug reactions (ADRs) reported in 101 of 1,671 patients (6.04 %); the most common reported ADRs were nausea, dizziness, headache, and palpitations. No clinically significant safety issues were identified, although 5 serious ADRs were reported in 4/1,671 (0.24 %) patients. At 12 months, 71.9 % of patients remained on teriparatide treatment. From 1 month, there were rapid increases in the biomarkers of bone formation P1NP and, to a lesser extent, BAP. In contrast, increases in the biomarkers of bone resorption, serum NTX, urinary NTX, and TRACP5b, were smaller. After 12 months of treatment, there was an increase in bone mineral density at the lumbar spine, femoral neck, and total hip, and a decrease in the Visual Analog Scale score for back pain. The incidence of new vertebral and nonvertebral fractures was 1.21 % and 3.18 %, respectively. In conclusion, the favorable safety profile and effectiveness of teriparatide observed in this population of Japanese patients with osteoporosis were accompanied by relatively high persistence with treatment, which is a key factor in the success of osteoporosis treatment.

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Acknowledgments

The authors acknowledge the efforts of the investigators who participated in the study and thank the contributors to manuscript preparation, editing, and review (Keisuke Shinkai, Noriko Takagaki, and Yasushige Masunaga of Eli Lilly Japan). Eli Lilly Japan was involved in the study design, data collection, data analysis, and preparation of the manuscript. This study was sponsored by Eli Lilly and Company, manufacturer of teriparatide. Medical writing assistance was provided by Justine Southby, PhD, and Janelle Keys, PhD, of ProScribe Medical Communications and was funded by Eli Lilly Japan K.K. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP2).

Conflict of interest

All authors are employees of Eli Lilly Japan.

Author information

Authors and Affiliations

  1. Medical Science, Lilly Research Laboratories Development Center of Excellence Japan, Eli Lilly Japan K.K., Sannomiya Plaza Bldg, 7-1-5 Isogamidori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan

    Takanori Yamamoto

  2. Medical Science, Lilly Research Laboratories Development Center of Excellence Japan, Eli Lilly Japan K.K., Kobe, Hyogo, Japan

    Masayo Sato & Hideaki Sowa

  3. Asia Pacific Statistical Sciences, Lilly Research Laboratories Development Center of Excellence Asia Pacific, Eli Lilly Japan K.K., Kobe, Hyogo, Japan

    Masanori Taketsuna

  4. Global Patient Safety Japan, Lilly Research Laboratories Development Center of Excellence Japan, Eli Lilly Japan K.K, Kobe, Hyogo, Japan

    Xiaoyan Guo

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  1. Takanori Yamamoto
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  2. Masanori Taketsuna
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  3. Xiaoyan Guo
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  4. Masayo Sato
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  5. Hideaki Sowa
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Correspondence to Takanori Yamamoto.

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Yamamoto, T., Taketsuna, M., Guo, X. et al. The safety and effectiveness profile of daily teriparatide in a prospective observational study in Japanese patients with osteoporosis at high risk for fracture: interim report. J Bone Miner Metab 32, 699–708 (2014). https://doi.org/10.1007/s00774-013-0546-6

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  • DOI: https://doi.org/10.1007/s00774-013-0546-6

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