PROTOCOL AND ENROLLMENT STATUS OF THE START-HOP TRIAL: A RANDOMIZED STUDY OF TWICE-WEEKLY TERIPARATIDE IN HEMODIALYSIS PATIENTS WITH OSTEOPOROSIS

 

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PROTOCOL AND ENROLLMENT STATUS OF THE START-HOP TRIAL: A RANDOMIZED STUDY OF TWICE-WEEKLY TERIPARATIDE IN HEMODIALYSIS PATIENTS WITH OSTEOPOROSIS

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Michiko
Kurotori
Michiko Kurotori m05083mf@jichi.ac.jp Faculty of Medicine and Graduate School of Medicine, Hokkaido University Department of Rheumatology, Endocrinology, and Nephrology Sapporo Japan *
Daigo Nakazawa daigo-na@med.hokudai.ac.jp Faculty of Medicine and Graduate School of Medicine, Hokkaido University Department of Rheumatology, Endocrinology, and Nephrology Sapporo Japan -
Kanako Watanabe-Kusunoki wata.kanako@gmail.com Faculty of Medicine and Graduate School of Medicine, Hokkaido University Department of Rheumatology, Endocrinology, and Nephrology Sapporo Japan -
Fumihiko Hattanda fumihiko_417@yahoo.co.jp Hokkaido University Hospital Department of Hemodialysis and Apheresis Sapporo Japan -
Saori Nishio saorin@med.hokudai.ac.jp Hokkaido University Hospital Department of Hemodialysis and Apheresis Sapporo Japan -
Tatsuya Atsumi at3tat@med.hokudai.ac.jp Faculty of Medicine and Graduate School of Medicine, Hokkaido University Department of Rheumatology, Endocrinology, and Nephrology Sapporo Japan -
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Patients with chronic kidney disease (CKD), particularly those undergoing hemodialysis (HD), are at increased risk of bone fractures, primarily due to CKD-mineral and bone disorder (CKD-MBD). Although secondary hyperparathyroidism (SHPT) can be managed using vitamin D analogs and calcimimetics, fracture risk remains elevated, highlighting the need for direct therapeutic interventions targeting bone density and quality. Unlike in the general population, treatment for osteoporosis has not yet been established for HD patients. Teriparatide, a recombinant human parathyroid hormone (PTH 1–34), has shown potential to improve bone mineral density (BMD) in HD patients with low PTH levels. However, previous studies using once-weekly formulations reported adverse events, including transient hypotension and high dropout rates, limiting the accumulation of robust evidence in this population. In contrast, the twice-weekly teriparatide autoinjector formulation has demonstrated improved adherence and ultimately a reduced incidence of adverse effects compared to the once-weekly formulation in patients with primary osteoporosis. The higher tolerability could lead to the better maintenance of bone density over time. This trial aims to assess the efficacy and safety of twice-weekly teriparatide in HD patients with well-controlled SHPT.

The START-HOP trial is a multicenter, prospective, randomized, open-label, controlled trial designed to evaluate the efficacy and safety of twice-weekly teriparatide (28.2 μg) in HD patients with osteoporosis. Eligible patients meeting the criteria for participation will be randomized (1:1) to either the teriparatide group or the control group (delayed-start teriparatide) (Figure 1). We set a target of 25 participants in each group (a total of 50) based on sample size calculations from a previous report. Randomization is performed using a web-based system, wherein patients are stratified by age, intact parathyroid hormone (iPTH) levels and percent Young Adult Mean(%YAM). The primary analysis will compare the percentage change in lumbar spine BMD after a 48-week period (Figure 1-1). Following the initial 48 weeks, participants in the teriparatide group will discontinue the medication, while those in the control group will start receiving teriparatide for an additional 48 weeks. Within-group analyses will be conducted to assess changes before and after teriparatide administration in all participants over a 48-week treatment period (Figure 1-2). 

To date, 38 patients have been randomly assigned to two groups (19 subjects to teriparatide and 19 to control). Baseline characteristics are well balanced between the two groups (Table 1). No substantial differences have been observed at enrollment. Data analysis is ongoing, and efficacy and safety outcomes will be reported after completion of the planned observation period.

This trial is the first randomized controlled study to evaluate the efficacy and safety of a twice-weekly 28.2µg teriparatide regimen in HD patients with osteoporosis and well-controlled SHPT. By presenting both the study protocol and current enrollment status, we aim to provide a foundation for evidence-based strategies to improve bone health in this high-risk population.

Kewords