Abstract
Introduction
Bisphosphonates are the standard treatment for glucocorticoid-induced osteoporosis (GIOP) with teriparatide being another option. While daily teriparatide has been shown to be effective in increasing bone mineral density (BMD), the efficacy of once-weekly teriparatide (56.5 µg) has not yet been evaluated. The TOWER-GO study, a 72-week, multicenter, open-label, randomized controlled trial, was conducted in patients with GIOP to compare the effects of once-weekly teriparatide and once-weekly alendronate 35 mg on BMD.
Materials and methods
Patients (N = 180) with GIOP for whom drug treatment was indicated according to the 2004 guidelines in Japan were randomized to receive once-weekly teriparatide (n = 89) or once-weekly alendronate (n = 91). The primary endpoint was the non-inferiority of percentage change in lumbar spine BMD at final follow-up. The secondary endpoints were the percentage change in BMD from baseline, incidence of bone fractures, and changes in bone turnover markers.
Results
While the non-inferiority of teriparatide to alendronate was not confirmed, BMD increased significantly from baseline with teriparatide and alendronate by 5.09% and 4.04%, respectively (both p < 0.05), at 72 weeks. The incidence of vertebral and non-vertebral fractures was similar in both groups. Bone formation markers increased in the teriparatide group and decreased in the alendronate group.
Conclusions
The non-inferiority of once-weekly teriparatide versus once-weekly alendronate in BMD change at 72 weeks was not shown, but the increase in bone formation markers over time and the increase of BMD in GIOP patients treated with once-weekly teriparatide were confirmed.
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Acknowledgements
The authors would like to thank the members of the GIOP (Glucocorticoid-induced Osteoporosis) study group for their contributions as co-investigators. This study was sponsored by Asahi Kasei Pharma Corporation.
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All authors contributed to the study conception and design. Data collection was performed by IT and HO. Data analysis was performed by SS and HO. The draft of the manuscript was written by IT, SS, and HO. All authors reviewed and commented on previous versions of the manuscript. The final manuscript was edited by IT and HO, and all authors read and approved the final version of manuscript.
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I.Tanaka has received speaking fees, and/or honoraria from Asahi Kasei Pharma, Astellas Pharma, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Eli Lilly Japan, Mitsubishi Tanabe Pharma, MSD, Ono Pharmaceutical, Pfizer Japan, Takeda Pharmaceutical, Taisho Pharma, and Teijin Pharma. Y. Tanaka has received speaking fees and/or honoraria from AbbVie, Astellas Pharma, Bristol-Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Eli Lilly Japan, Janssen Pharmaceutical, Mitsubishi Tanabe Pharma, Novartis Pharma, Pfizer Japan, Takeda Pharmaceutical, Teijin Pharma, and YL Biologics and has received research grants from Asahi Kasei Pharma, Bristol-Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Mitsubishi Tanabe Pharma, Ono Pharmaceutical, Sanofi, Takeda Pharmaceutical, and UCB Japan. S. Soen has received consulting fees, speaking fees, and/or honoraria from Asahi Kasei Pharma, Astellas Pharma, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Eli Lilly Japan, MSD, Ono Pharmaceutical, Pfizer Japan, Takeda Pharmaceutical, and Teijin Pharma. H. Oshima has no conflicts of interest.
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Tanaka, I., Tanaka, Y., Soen, S. et al. Efficacy of once-weekly teriparatide in patients with glucocorticoid-induced osteoporosis: the TOWER-GO study. J Bone Miner Metab 39, 446–455 (2021). https://doi.org/10.1007/s00774-020-01171-5
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DOI: https://doi.org/10.1007/s00774-020-01171-5