Efficacy and safety of twice-weekly teriparatide in hemodialysis patients with osteoporosis: protocol for a randomized controlled trial (START-HOP trial)
Abstract
Patients with chronic kidney disease (CKD), particularly those undergoing hemodialysis (HD), are at increased risk of bone fractures due to multifactorial skeletal fragility associated with CKD–mineral and bone disorder (CKD–MBD), secondary osteoporosis, and metabolic and nutritional abnormalities. Although secondary hyperparathyroidism (SHPT) can be managed using vitamin D analogs and calcimimetics, fracture risk often remains elevated despite appropriate CKD–MBD management, highlighting the need for therapies directly targeting skeletal fragility. Teriparatide, a synthetic human parathyroid hormone (PTH 1–34), has shown potential to improve bone mineral density (BMD) in patients with low PTH levels, although the evidence remains limited, particularly in dialysis populations. Notably, previous studies have employed once-weekly formulations, which have been associated with transient hypotension and a high rate of treatment discontinuation, thereby limiting the accumulation of robust evidence in this population. In contrast, the twice-weekly teriparatide autoinjector formulation may cause fewer adverse effects and would enhance treatment adherence. This improved tolerability could lead to better outcome of bone density maintenance over time. This trial aims to address the lack of evidence regarding teriparatide use in HD patients with adequately controlled SHPT.
The START-HOP trial is a multicenter, prospective, randomized, open-label, controlled trial designed to evaluate…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 50 participants or records.
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