Safety and effectiveness of daily teriparatide in a prospective observational study in patients with osteoporosis at high risk of fracture in Japan: final report

Nishikawa, Atsushi; Ishida, Toshihisa; Taketsuna, Masanori; Yoshiki, Fumito; Enomoto, Hiroyuki

doi:10.2147/cia.s107285

Cited by 29 publications

(27 citation statements)

References 42 publications

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“…In 2005, ∼13% of the Japanese adult population were estimated to have CKD and this figure is likely to be even higher in the elderly 6,7. Osteoporosis and early-stage CKD frequently coexist and ∼20% of patients with osteoporosis have stage 3 or 4 CKD 8. Further, osteoporosis and CKD are among the most common age-related comorbidities that independently impair bone strength 9–11.…”

Section: Introductionmentioning

confidence: 99%

“…A 24-month postmarketing surveillance (PMS) study demonstrated the safety and effectiveness of daily teriparatide in 1,847 patients with osteoporosis at high risk of fracture in Japan 8. Most (92.6%) patients included in the original PMS study were female and postmenopausal (90.8%), with a mean age of 75.4 years 8.…”

Section: Introductionmentioning

confidence: 99%

“…Most (92.6%) patients included in the original PMS study were female and postmenopausal (90.8%), with a mean age of 75.4 years 8. Further, in the original PMS study, most patients were categorized as having stage 2 (38.4%) or stage 3 (18.9%) CKD, followed by stage 1 (10.5%) CKD.…”

Section: Introductionmentioning

confidence: 99%

“…Further, in the original PMS study, most patients were categorized as having stage 2 (38.4%) or stage 3 (18.9%) CKD, followed by stage 1 (10.5%) CKD. Patients with severe stages of CKD (stage 4 [1.6%], stage 5 [0.2%]) made up a small percentage of the study population 8. Treatment with teriparatide led to significant increases in biomarkers for bone formation/resorption and BMD, together with low incidences of new vertebral and nonvertebral fractures and significant improvements in patient-reported measurements for health-related quality of life 8.…”

Section: Introductionmentioning

confidence: 99%

“…Patients with severe stages of CKD (stage 4 [1.6%], stage 5 [0.2%]) made up a small percentage of the study population 8. Treatment with teriparatide led to significant increases in biomarkers for bone formation/resorption and BMD, together with low incidences of new vertebral and nonvertebral fractures and significant improvements in patient-reported measurements for health-related quality of life 8. We conducted a post hoc analysis of this PMS study to explore the safety and effectiveness of daily teriparatide used in a clinical setting only among patients with severe stages of CKD and osteoporosis with a high risk of fracture.…”

Section: Introductionmentioning

confidence: 99%

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Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study

Nishikawa¹,

Yoshiki²,

Taketsuna³

et al. 2016

CIA

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Teriparatide (recombinant 1–34 N-terminal sequence of human parathyroid hormone) for the treatment of osteoporosis should be prescribed with caution in patients with severe stages of chronic kidney disease (CKD). However, in clinical settings, physicians and surgeons who treat such patients have few available options. We sought to further explore the safety and effectiveness of teriparatide for the treatment of osteoporosis in Japanese patients with severe stages of CKD. This was a post hoc analysis of a postmarketing surveillance study that included patients with osteoporosis at high risk of fracture and stage 4 or 5 CKD. Patients received subcutaneous teriparatide 20 μg daily for up to 24 months. Safety profiles were assessed by physician-reported adverse drug reactions (ADRs). Effectiveness was assessed by measuring bone formation (via procollagen type 1 N-terminal propeptide [P1NP]), bone mineral density (BMD), and the incidence of clinical vertebral or nonvertebral fragility fractures. A total of 33 patients with severe stages of CKD (stage 4, n=30; stage 5, n=3) were included. All patients were female, and 81.8% had a history of previous fracture. No serious ADRs were recorded; a total of 4 ADRs were recorded for 4 of 33 patients. Increases in BMD and P1NP levels were observed both overall and in most individual patients. New fractures occurred in 1 patient with stage 5 CKD, but not in patients with stage 4 CKD. In this post hoc analysis conducted in Japan, teriparatide appeared to be effective for the treatment of osteoporosis in elderly female patients with severe stages of CKD, and no new safety concerns were observed.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study

Nishikawa¹,

Yoshiki²,

Taketsuna³

et al. 2016

CIA

Self Cite

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Transitory Activation and Improved Transition from Erosion to Formation within Intracortical Bone Remodeling in Hypoparathyroid Patients Treated with rhPTH(1–84)

van Dijk Christiansen,

Sikjær,

Andreasen

et al. 2023

JBMR Plus

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In hypoparathyroidism, lack of parathyroid hormone (PTH) leads to low calcium levels and decreased bone remodeling. Treatment with recombinant human PTH (rhPTH) may normalize bone turnover. This study aimed to investigate whether rhPTH(1–84) continued to activate intracortical bone remodeling after 30 months and promoted the transition from erosion to formation and whether this effect was transitory when rhPTH(1–84) was discontinued. Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1–84) a day (n = 21) (PTH) or similar placebo (n = 21) (PLB) for 6 months as add‐on to conventional therapy. This was followed by an open‐label extension, where patients extended their rhPTH(1–84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1–84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8). Bone biopsies were collected at months 6 (n = 42) and 30 (n = 18). After 6 and 30 months, the overall cortical microarchitecture (cortical porosity, thickness, pore density, and mean pore diameter) in the PTH group did not differ from that of the PLB/CON and PTHw groups. Still, the PTH group had a significantly and persistently higher percentage of pores undergoing remodeling than the PLB/CON groups. A significantly higher percentage of these pores was undergoing bone formation in the PTH compared with the PLB/CON groups, whereas the percentage of pores with erosion only was not different. This resulted in a shift in the ratio between formative and eroded pores, reflecting a faster transition from erosion to formation in the PTH‐treated patients. In the rhPTH(1–84) withdrawal group PTHw, the latter effects of PTH were completely reversed in comparison to those of the PLB/CON groups. In conclusion, rhPTH(1–84) replacement therapy in hypoparathyroidism patients promotes intracortical remodeling and its transition from erosion to formation without affecting the overall cortical microstructure. The effect persists for at least 30 months and is reversible when treatment is withdrawn. © 2023 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

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Osteoporosis Management with Focus on Spine

Kushchayeva

Lewiecki

2021

Image Guided Interventions of the Spine

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Safety and effectiveness of daily teriparatide in a prospective observational study in patients with osteoporosis at high risk of fracture in Japan: final report

Cited by 29 publications

References 42 publications

Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study

Safety and effectiveness of daily teriparatide for osteoporosis in patients with severe stages of chronic kidney disease: post hoc analysis of a postmarketing observational study

Transitory Activation and Improved Transition from Erosion to Formation within Intracortical Bone Remodeling in Hypoparathyroid Patients Treated with rhPTH(1–84)

Osteoporosis Management with Focus on Spine

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