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临床试验/NCT05426512
NCT05426512已完成不适用

Effect of Mechanical Loading on vBMD and Geometry in Patients With Primary Hyperparathyroidism

EFSTATHIOS CHRONOPOULOS0 个研究点目标入组 120 人开始时间: 2016年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
主要终点
Effect of mechanical loading on vBMD and geometry in patients with primary hyperparathyroidism

研究概览

简要总结

In this study we aimed to evaluate the effect of primary hyperparathyroidism (PHPT) on bone geometry simultaneously at the tibia and the radius, peripheral bone sites with similar structure but subject to different loading conditions. This evaluation was made by comparing z-scores of bone parameters measured by peripheral quantitative computed tomography (pQCT).

详细描述

Postmenopausal women with primary hyperparathyroidism will be included in the study. The diagnosis of primary hyperparathyroidism is based on the high levels of parathyroid hormone and calcium.

Postmenopausal women with kidney failure, liver failure, malabsorption syndromes, women under medication that can affect the levels of the parathyroid hormone (lithium, thiazide diuretics) and calcium levels (oestrogen, loop diuretics, denosumab, bisphosphonates), corticosteroids, and women diagnosed with familial hypocalciuric hypercalcemia will be excluded from the study.

The control group has similar demographic characteristics and years of menopause with the patients that have primary hyperparathyroidism. Their calcium and parathyroid hormone levels are within the normal range and there is an absence of any secondary causes of osteoporosis.

The patients' medical files will be taken from the archives of the Laboratory for research of the Musculoskeletal System 'Th.Garofalidis', Medical School, National and Kapodistrian University of Athens, KAT General Hospital of Athens. The records of these patients will be used for the recording of the total calcium levels, parathyroid hormone levels, vitamin D, creatinine, albumin, alkaline phosphatase (ALP), along with bone mineral density at the lumbar spine and femur, with the use of dual-energy x-ray absorptiometry (DEXA). Moreover, pQCT measurements of bone parameters in the region 4% (trabecular bone) and 38% (cortical bone) at the tibia and in the region 4% (trabecular bone) and 20% (cortical bone) at the radius will be recorded. pQCT bone parameters that will be recorded include total bone mineral content (tot BMC), cortical bone mineral content (cort BMC), trabecular bone mineral content (trab BMC), total bone mineral density (tot BMD), cortical bone mineral density (cort BMD), trabecular bone mineral density (trab BMD), total area (tot AREA), trabecular area (trab AREA), cortical area (cort AREA), cortical thickness (cort THICK), endocortical and periosteal circumference (enco C and peri C) and calculation of SSI.

The primary endpoint of the study will be the comparison between the z-scores of the volumetric bone mineral density of the trabecular (trab BMD) and cortical bone (cort BMD) between the tibia and the radius. Secondary endpoints will be the differences between z-scores of the following variables in the region of the tibia and the radius. (trab BMC, cort BMC, trab AREA, cort AREA, cort THICK, endo C, peri C και SSI). Finally, the study will focus on if any differences between the z-scores are related to the severity of primary hyperparathyroidism, as it is defined by the levels of the parathyroid hormone and calcium.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Caucasian postmenopausal women with PHPT

排除标准

  • Chronic kidney disease (eGFR< 60 ml/min/1.73m2), Liver disease Malabsorption syndromes Rheumatic disease Women under medication that could affect aBMD or vBMD measurements, PTH, and /or calcium levels (lithium, thiazide/loop diuretics, estrogen, SERMS, denosumab, bisphosphonates) and corticosteroids

结局指标

主要结局

Effect of mechanical loading on vBMD and geometry in patients with primary hyperparathyroidism

时间窗: Up to 24 weeks

z-score for total volumetric bone mineral density (tot vBMD)

次要结局

未报告次要终点

研究者

发起方
EFSTATHIOS CHRONOPOULOS
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

EFSTATHIOS CHRONOPOULOS

Associate Professor in Orthopaedics at National and Kapodistrian University of Athens, Laboratory for Research of the Musculoskeletal System Director

National and Kapodistrian University of Athens

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