KMID : 1120320200060010015
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Osteoporosis and Sarcopenia 2020 Volume.6 No. 1 p.15 ~ p.19
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Association between elcatonin use and cancer risk in Japan: A follow-up study after a randomized, double-blind, placebo-controlled study of once-weekly elcatonin in primary postmenopausal osteoporosis
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Okamoto Hiroaki
Shibazaki Nayumi Yoshimura Takeshi Uzawa Toyonobu Sugimoto Toshitsugu
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Abstract
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Objectives: On July 20, 2012, the European Medicines Agency (EMA) provided a recommendation that limits the long-term use of calcitonin. Based on this recommendation, we investigate the presence or absence of a cancer diagnosis in subjects who participated in the ongoing clinical trial of elcatonin.
Methods: When the EMA gave this recommendation, we were conducting ¡°a 3-year placebo-controlled clinical study for elcatonin¡± (hereinafter, referred to as ¡°the original study¡±). In accordance with the recommendation of EMA, we performed an intermediate analysis on the subjects of the original study to assess whether the study could be safely continued. We also added a 2-year follow-up study to investigate the risk of carcinogenesis for 5 years from the start of administration. We compared the risk of carcinogenesis estimated by person-year method in elcatonin group with that in placebo group.
Results: In the original study, there were 433 subjects in the elcatonin group and 437 in the placebo group, of whom 322 and 323, respectively, agreed to participate in the additional follow-up study. The average cancer incidence rate per 100 person-years 5 years from the start of administration was 1.02 in the elcatonin group and 1.08 in the placebo group, respectively, and there was no clear difference.
Conclusions: Since the number of cases in this study was small, we cannot completely deny the cancer risk due to long-term administration of this drug. However, the results do not suggest that once-weekly administration of 20 units of elcatonin increases the carcinogenic risk.
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KEYWORD
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Calcitonin, Elcatonin, Once-weekly injection, Osteoporosis, Cancer risk
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