Association Between Renal Function and Fracture Incidence During Treatment with Teriparatide or Alendronate: an Exploratory Subgroup Analysis of the Japanese Osteoporosis Intervention Trial-05

Overview

Journal Osteoporos Int

Specialties Endocrinology
Orthopedics

Date 2024 Sep 29

PMID 39343826

Authors

Yasuhiro Takeuchi

Shiro Tanaka

Tatsuhiko Kuroda

Hiroshi Hagino

Satoshi Mori

Satoshi Soen

Affiliations

Soon will be listed here.

Abstract

Purpose: Incidence rate of morphometric vertebral fracture was lower under treatment with once-weekly teriparatide (TPTD) followed by alendronate (ALN) than under treatment with ALN throughout the study among elderly Japanese women at high fracture risk in JOINT-05. This is an exploratory subgroup analysis according to chronic kidney disease (CKD) status at baseline.

Methods: Participants received sequential therapy with TPTD for 72 weeks, followed by ALN for 48 weeks (TPTD-ALN group, N = 483) or ALN monotherapy for 120 weeks (ALN group, N = 496). Baseline CKD status was classified by the estimated glomerular filtration rate (eGFR) and categorized as: CKD 1/2 (eGFR ≥ 60 mL/min/1.73 m), CKD 3a (eGFR 45-59 mL/min/1.73 m), or CKD 3b/4 (eGFR < 45 mL/min/1.73 m). Incidences of vertebral fractures including morphometric fractures, non-vertebral fractures, and all fractures were evaluated during follow-up.

Results: Baseline characteristics were not different between treatment groups. Higher stages of CKD were associated with age and number of prevalent vertebral fracture. In CKD 1/2 patients (N = 556 with 90 incidents of morphometric vertebral fracture), the incidence of vertebral fractures was lower in the TPTD-ALN group than in the ALN group (p = 0.01). In CKD 3b/4 patients (N = 112 with 10 incidents of non-vertebral fracture), the incidence of non-vertebral fractures was lower in the ALN group than in the TPTD-ALN group, although the number of fractures was small. In the ALN group, the incidences of vertebral fractures, non-vertebral fractures, and all fractures remained constant across CKD stages.

Conclusion: This exploratory analysis showed that fracture incidence on ALN was constant regardless of renal function. It also suggested that the incidence of vertebral fractures on TPTD-ALN was lower than ALN monotherapy in CKD 1/2 patients. These results provide important information for drug selection in the clinical practice of osteoporosis.

References

Qiu S, Divine G, Rao S . Effect of vitamin D metabolites on bone histomorphometry in healthy black and white women: An attempt to unravel the so-called vitamin D paradox in blacks. Bone Rep. 2023; 18:101650. PMC: 9801084. DOI: 10.1016/j.bonr.2022.101650. View

Nitta K, Yajima A, Tsuchiya K . Management of Osteoporosis in Chronic Kidney Disease. Intern Med. 2017; 56(24):3271-3276. PMC: 5790712. DOI: 10.2169/internalmedicine.8618-16. View

Bellorin-Font E, Rojas E, Martin K . Bone Disease in Chronic Kidney Disease and Kidney Transplant. Nutrients. 2023; 15(1). PMC: 9824497. DOI: 10.3390/nu15010167. View

Tanaka S, Mori S, Hagino H, Sugimoto T . Design of a randomized trial of teriparatide followed by alendronate: Japanese Osteoporosis Intervention Trial-05 (JOINT-05). J Bone Miner Metab. 2020; 38(3):412-417. DOI: 10.1007/s00774-019-01074-0. View

van Doorn L, Lips P, Netelenbos J, HACKENG W . Bone histomorphometry and serum concentrations of intact parathyroid hormone (PTH(1-84)) in patients with primary hyperparathyroidism. Bone Miner. 1993; 23(3):233-42. DOI: 10.1016/s0169-6009(08)80100-6. View

Jamal S, Bauer D, Ensrud K, Cauley J, Hochberg M, Ishani A . Alendronate treatment in women with normal to severely impaired renal function: an analysis of the fracture intervention trial. J Bone Miner Res. 2007; 22(4):503-8. DOI: 10.1359/jbmr.070112. View

Matsuo S, Imai E, Horio M, Yasuda Y, Tomita K, Nitta K . Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis. 2009; 53(6):982-92. DOI: 10.1053/j.ajkd.2008.12.034. View

Neer R, Arnaud C, Zanchetta J, Prince R, Gaich G, Reginster J . Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001; 344(19):1434-41. DOI: 10.1056/NEJM200105103441904. View

Naylor K, McArthur E, Leslie W, Fraser L, Jamal S, Cadarette S . The three-year incidence of fracture in chronic kidney disease. Kidney Int. 2014; 86(4):810-8. DOI: 10.1038/ki.2013.547. View

10.

Miller P, Adachi J, Albergaria B, Cheung A, Chines A, Gielen E . Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease. J Bone Miner Res. 2022; 37(8):1437-1445. PMC: 9544335. DOI: 10.1002/jbmr.4563. View

11.

Yamada S, Inaba M, Kurajoh M, Shidara K, Imanishi Y, Ishimura E . Utility of serum tartrate-resistant acid phosphatase (TRACP5b) as a bone resorption marker in patients with chronic kidney disease: independence from renal dysfunction. Clin Endocrinol (Oxf). 2008; 69(2):189-96. DOI: 10.1111/j.1365-2265.2008.03187.x. View

12.

Nakamura T, Sugimoto T, Nakano T, Kishimoto H, Ito M, Fukunaga M . 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. 2012; 97(9):3097-106. DOI: 10.1210/jc.2011-3479. View

13.

Miller P, Roux C, Boonen S, Barton I, Dunlap L, Burgio D . Safety and efficacy of risedronate in patients with age-related reduced renal function as estimated by the Cockcroft and Gault method: a pooled analysis of nine clinical trials. J Bone Miner Res. 2005; 20(12):2105-15. DOI: 10.1359/JBMR.050817. View

14.

Miller P, Schwartz E, Chen P, Misurski D, Krege J . Teriparatide in postmenopausal women with osteoporosis and mild or moderate renal impairment. Osteoporos Int. 2006; 18(1):59-68. DOI: 10.1007/s00198-006-0189-8. View

15.

Genant H, Wu C, van Kuijk C, Nevitt M . Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res. 1993; 8(9):1137-48. DOI: 10.1002/jbmr.5650080915. View

16.

Jamal S, Ljunggren O, Stehman-Breen C, Cummings S, McClung M, Goemaere S . Effects of denosumab on fracture and bone mineral density by level of kidney function. J Bone Miner Res. 2011; 26(8):1829-35. DOI: 10.1002/jbmr.403. View

17.

Moe S, Drueke T, Lameire N, Eknoyan G . Chronic kidney disease-mineral-bone disorder: a new paradigm. Adv Chronic Kidney Dis. 2007; 14(1):3-12. DOI: 10.1053/j.ackd.2006.10.005. View

18.

Compston J, McClung M, Leslie W . Osteoporosis. Lancet. 2019; 393(10169):364-376. DOI: 10.1016/S0140-6736(18)32112-3. View

19.

Mori S, Hagino H, Sugimoto T, Tanaka S, Mitomo Y, Takahashi K . Sequential therapy with once-weekly teriparatide injection followed by alendronate versus monotherapy with alendronate alone in patients at high risk of osteoporotic fracture: final results of the Japanese Osteoporosis Intervention Trial-05. Osteoporos Int. 2022; 34(1):189-199. PMC: 9813198. DOI: 10.1007/s00198-022-06570-0. View

20.

. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 2009; (113):S1-130. DOI: 10.1038/ki.2009.188. View