Comparison of once-weekly teriparatide and alendronate against new osteoporotic vertebral fractures at week 12
- 2 Downloads
The objective of the present multicenter randomized study was to compare weekly teriparatide with alendronate in their inhibition of vertebral collapse, effects on delayed union, pain relief, and improvement of quality of life (QOL) in women with new osteoporotic vertebral fractures within 1 week after onset of the fracture. Patients were randomly allocated to the teriparatide and alendronate groups. Vertebral collapse, low back pain assessed by a visual analog scale, and QOL assessed by EuroQol 5 dimension at weeks 1, 2, 4, 8, and 12 after the start of the treatment were compared between the groups. Lumbar bone mineral density (BMD) at baseline and week 12 and the rate of delayed union at week 12 were also compared. Each group consisted of 48 subjects. Vertebral collapse progressed over time in both groups, with no significant difference between the groups. Pain on rising up from lying position, turning over in bed, and resting in the lying position improved over time in both groups, with no significant difference between the groups. There were no significant differences in increase in BMD and delayed union. QOL in the teriparatide group showed significant improvement in comparison with that in the alendronate group at week 12. The weekly formulation of teriparatide showed comparable inhibition of vertebral collapse, increase in BMD, promotion of bone union, and improvement of pain and significant improvement of QOL at week 12 in comparison with alendronate in patients with a new osteoporotic vertebral fracture within 1 week after onset of the fracture. The weekly formulation of teriparatide may have improved components of QOL other than pain at week 12.
KeywordsEuroQol 5 dimension Delayed union Kyphosis angle Visual analog scale Wedge angle
The authors would like to express their gratitude to the study patients for their participation. The authors would also like to acknowledge the assistance of Kazumasa Tanzawa, EPS Corporation and KOTU T-WRAP study Investigators. The study was funded by the Asahi Kasei Pharma Corporation.
SI designed the study and wrote the initial draft of the manuscript. Other authors have contributed to data collection and interpretation, and critically reviewed the manuscript. All authors contributed to analysis and interpretation of data, approved the final version of the manuscript, and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Compliance with ethical standards
Conflict of interest
S. Ikeda has received payments for lectures, including speakers’ bureau fees, from Chugai Pharmaceutical Co., Ltd, Daiichi-Sankyo Co., Ltd., Pfizer Japan Inc., Takeda Pharmaceutical Co., and Teijin Pharma Ltd. A Sakai has received lecture fee from Asahi Kasei Pharma Corporation and Chugai Pharmaceutical Co., Ltd. E Nakamura, K Narusawa, F Fukuda, H Matsumoto, K Nakai, T Sakata, T Yoshioka, and Y Fujino declare that they have no conflict of interest.
The study protocol and associated documents used in this study were reviewed and approved by the internal review board at each study site in accordance with the Declaration of Helsinki. All procedures in this study involving human participants were performed in accordance with the ethical standards of the institutional and/or national research committee and with the Declaration of Helsinki and its later amendments or comparable ethical standards.
Written informed consent was obtained from all individual participants included in this study before initiating any procedures.
- 1.United Nations, World Population Prospects: The 2015 Revision UN Department of Economic and Social Affairs GenevaGoogle Scholar
- 11.Miyakoshi N, Kobayashi T, Suzuki T, Kikuchi K, Kasukawa Y, Shimada Y (2017) Perioperative medical complications after posterior approach spinal instrumentation surgery for osteoporotic vertebral collapse: a comparative study in patients with primary osteoporosis and those with secondary osteoporosis. Asian Spine J 11:756–762CrossRefGoogle Scholar
- 12.Nakamura T, Sugimoto T, Nakano T, Kishimoto H, Ito M, Fukunaga M, Hagino H, Sone T, Yoshikawa H, Nishizawa Y, Fujita T, Shiraki M (2012) Randomized Teriparatide [human parathyroid hormone (PTH) 1–34] Once-Weekly Efficacy Research (TOWER) trial for examining the reduction in new vertebral fractures in subjects with primary osteoporosis and high fracture risk. J Clin Endocrinol Metab 97:3097–3106CrossRefGoogle Scholar
- 16.Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, Bauer DC, Genant HK, Haskell WL, Marcus R, Ott SM, Torner JC, Quandt SA, Reiss TF, Ensrud KE (1996) Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 348:1535–1541Google Scholar
- 22.Okimoto N, Uemura Y, Yoshioka T, Arita S, Tsurukami H, Otomo H, Nishida S, Ogawa T, Hirao k, Ikeda S, Matsumoto H, Toten Y, Katae Y, Okazaki Y, Nakagawa T, Sakai A (2018) Treatment with once-weekly alendronate oral jelly compared with once-weekly alendronate oral tablet for Japanese patients with primary osteoporosis: an open-label, prospective, observational study. Health Sci Rep 2:e107. https://doi.org/10.1002/hsr2.107 CrossRefGoogle Scholar
- 26.Jakob F, Oertel H, Langdahl B, Ljunggren O, Barrett A, Karras D, Walsh JB, Fahrleitner-Pammer A, Rajzbaum G, Barker C, Lems WF, Marin F (2012) Effects of teriparatide in postmenopausal women with osteoporosis pre-treated with bisphosphonates: 36-month results from the European Forsteo Observational Study. Eur J Endocrinol 166:87–97CrossRefGoogle Scholar
- 27.Langdahl BL, Rajzbaum G, Jakob F, Karras D, Ljunggren O, Lems WF, Fahrleitner-Pammer A, Walsh JB, Barker C, Kutahov A, Marin F (2009) Reduction in fracture rate and back pain and increased quality of life in postmenopausal women treated with teriparatide: 18-month data from the European Forsteo Observational Study (EFOS). Calcif Tissue Int 85:484–493CrossRefGoogle Scholar
- 28.Soen S, Fujiwara S, Takayanagi R, kajimoto K, Tsujimoto M, Kimura S, Sato M, Krege JH, Enomoto H (2017) Real-world effectiveness of daily teriparatide in Japanese patients with osteoporosis at high risk for fracture: final results from the 24-month Japan Fracture Observational Study (JFOS). Curr Med Res Opin 33:2049–2056CrossRefGoogle Scholar