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Randomized Controlled Trial
. 2024 May;42(3):382-388.
doi: 10.1007/s00774-024-01515-5. Epub 2024 May 16.

Achieving osteoporosis treat-to-target goals with teriparatide or alendronate: sub-analysis of Japanese Osteoporosis Intervention Trial-05 (JOINT-05)

Hiroshi Hagino  1 , Shiro Tanaka  2 , Tatsuhiko Kuroda  3 , Satoshi Mori  4 , Satoshi Soen  5
Affiliations
Randomized Controlled Trial

Achieving osteoporosis treat-to-target goals with teriparatide or alendronate: sub-analysis of Japanese Osteoporosis Intervention Trial-05 (JOINT-05)

Hiroshi Hagino et al. J Bone Miner Metab. 2024 May.

Abstract

Introduction: The purpose of this study was to evaluate whether bone mineral density (BMD) ≥ -2.5 SD could be used as the treat-to-target (T2T) goal when treating osteoporosis with teriparatide (TPTD) and alendronate (ALN), and to investigate the relationship with incident vertebral fracture by re-analyzing data from a randomized, controlled trial (JOINT-05) involving postmenopausal Japanese women at high fracture risk.

Materials and methods: Participants received sequential therapy with once-weekly TPTD for 72 weeks, followed by ALN for 48 weeks (TPTD-ALN group) or ALN monotherapy for 120 weeks (ALN group). BMDs were measured at the lumbar spine (L2-4), total hip, and femoral neck at 0, 24, 48, 72, and 120 weeks by dual-energy X-ray absorptiometry. The T2T goal was BMD ≥ -2.5 SD, and the endpoint was the proportion of participants with baseline BMD < -2.5 SD in three measurement sites achieving BMD ≥ -2.5 SD.

Results: A total of 559 participants were selected. BMD ≥ -2.5 SD at 120 weeks in the L2-4, total hip, and femoral neck sites was achieved in 20.5%, 23.1%, and 5.9%, respectively, in the TPTD-ALN group and 22.2%, 11.7%, and 7.3%, respectively, in the ALN group. Incident vertebral fractures occurred in areas of both lower and high BMD.

Conclusion: During the 1.5-year treatment period, more than 20% of participants achieved BMD ≥ -2.5 SD as a T2T goal at L2-4. Since the achievement level differed depending on the BMD measurement site, the appropriate site should be selected according to the baseline BMD level.

Keywords: Bone mineral density; Measurement site; Osteoporosis; Teriparatide; Treat-to-target.

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Conflict of interest statement

Dr. Hagino received lecture fees or grants outside the submitted work from Amgen Inc., Asahi Kasei Pharma Corp., Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Mochida Pharma Co., Ltd., Teijin Pharma Ltd., and UCB Japan Co., Ltd. Dr. Tanaka has received lecture fees from the Research Institute of Healthcare Data Science. He has received consultation and outsourcing fees from Eli Lilly and Company, Welby, Daiichi Sankyo Company, Limited, Janssen Pharmaceutical K.K., Satt, and the Public Health Research Foundation. He has received research grants from the Japan Agency for Medical Research and Development, the Japanese Ministry of Health Labour and Welfare, the Japanese Ministry of Education, Science, and Technology, and Novo Nordisk. He engaged in a research project of the Japan Agency for Medical Research and Development. Dr. Soen has received consulting fees, speaking fees, and/or honoraria from Amgen Inc., Asahi Kasei Pharma Corp., Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan Co., Ltd., Mochida Pharma Co., Ltd., Ono Pharmaceutical Co., Ltd., Teijin Pharma Ltd., and UCB Japan Co., Ltd. Dr. Kuroda and Dr. Mori declare no competing interests.

Figures

Fig. 1
Fig. 1
Change in BMD by treatment group and measurement site. Changes in T-score from baseline in L2-4, total hip, femoral neck BMDs are shown in the teriparatide to alendronate (TPTD-ALN) and alendronate (ALN) groups by measurement week. Data are mean percent change ± standard deviation. *P < 0.05 for comparison with 0 weeks
Fig. 2
Fig. 2
Waterfall plot for the relationship between BMD status and incident vertebral fractures, L2-4 (a), total hip (b), and femoral neck (c) BMD T-scores and incident vertebral fractures in the teriparatide to alendronate (TPTD-ALN) group and the alendronate (ALN) group at 72 weeks and 120 weeks
See this image and copyright information in PMC

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