Real-World Data for Effectiveness and Safety of Palopegteriparatide in Patients With Chronic Hypoparathyroidism in Greece
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time to achievement of independence from activated vitamin D and oral calcium supplementation
研究概览
简要总结
This is a multicenter, prospective cohort study conducted across 9 tertiary and university hospitals in the rural area of Athens, which investigates the clinical and biochemical effects of palopegteriparatide (TransCon PTH) in adult patients with chronic hypoparathyroidism (≥12 months). Eligible participants included those transitioning from conventional therapy (activated vitamin D analogs and oral calcium) and those previously treated with rhPTH(1-84). The primary objective was to assess the time to independence from activated vitamin D and calcium supplementation. Secondary objectives included changes in biochemical parameters, incidence of clinically significant hypo- and hypercalcemia during the titration period , and reduction in daily pill burden. Patients received individualized doses of palopegteriparatide with follow-up visits at regular intervals, and safety was monitored throughout the study according to standard clinical practice.
详细描述
2. Subjects and Methods 2.1 Study Design and Setting
This was a multicenter, prospective cohort study conducted across 9 tertiary and university hospitals in the rural area of Athens. Eligible participants were enrolled from specialized centers experienced in the management of HypoPT between the date that palopegteriparatide was commercially available in Greece (first patient initiating palopegteriparatide was in June 2024) and September 2025. The study included two predefined patient cohorts:
- Individuals transitioning from conventional therapy (activated vitamin D analogs and calcium supplementation), and
- Individuals previously treated with rhPTH(1-84) before switching to palopegteriparatide.
2.1.1Participants Adult patients (≥18 years) with a confirmed diagnosis of chronic hypoparathyroidism (HypoPT) of at least 12 months' duration who initiated palopegteriparatide (TransCon PTH)were eligible for inclusion. All participants fulfilled the criteria for PTH replacement therapy as defined by the Hellenic Endocrine Society guidelines.
Diagnosis of chronic HypoPT was established by persistent hypocalcemia in conjunction with inappropriately low or normal serum parathyroid hormone (PTH) concentrations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years) with a confirmed diagnosis of chronic hypoparathyroidism (HypoPT) of at least 12 months' duration who initiated palopegteriparatide (TransCon PTH)
排除标准
- •i) transient postsurgical HypoPT ii) severe renal impairment (eGFR < 30 mL/min/1.73 m²) iii) active malignancy iv) Individuals with impaired responsiveness to PTH (pseudohypoparathyroidism) or any disease that might affect calcium metabolism, phosphate homeostasis, or PTH levels other than hypoparathyroidism v) other drugs known to influence calcium and bone metabolism (except for activated vitamin D analogs and elemental calcium) such as osteoporosis therapies or glucocorticoids other than as replacement therapy.
研究组 & 干预措施
Chronic hypoparathyroidism patients treated with palopegteriparatide
Adult patients with chronic hypoparathyroidism (≥12 months) initiating treatment with palopegteriparatide (TransCon PTH). The cohort includes patients transitioning from conventional therapy (activated vitamin D and calcium supplementation) as well as patients previously treated with rhPTH(1-84). Palopegteriparatide doses were individually titrated based on serum calcium levels and clinical response. Concomitant calcium and activated vitamin D supplementation were adjusted or discontinued according to the treating physician's discretion.
结局指标
主要结局
Time to achievement of independence from activated vitamin D and oral calcium supplementation
时间窗: From June 2024 (commercial availability of palopegteriparatide in Greece) through September 2025 (end of observation period).
The primary endpoint was the time to achievement of independence from activated vitamin D and oral calcium supplementation following initiation of palopegteriparatide. Independence was defined as the absence of any activated vitamin D or calcium supplementation for at least four consecutive weeks, without any increase in the palopegteriparatide dose during that period.
次要结局
- Clinical and Biochemical Outcomes Following Palopegteriparatide Treatment in HypoPT Patients(From June 2024 (commercial availability of palopegteriparatide in Greece) through September 2025 (end of observation period).)
- II. To asses changes in albumin corrected calcium levels between baseline and last visit(baseline to last visit within the 14 months of treatmemt)
- II. To asses changes in phosphate levels between baseline and last visit(baseline to last visit within the 14 months of treatmemt)
- II. To asses changes in calcium 24 hour urine levels between baseline and last visit(baseline to last visit within the 14 months of treatmemt)
- II. To asses changes in magnesium levels between baseline and last visit(baseline to last visit within the 14 months of treatmemt)
研究者
Maria Yavropoulou
Senior Endocrinology Consultant
Laikο General Hospital, Athens