Treatment of hypoparathyroidism with subcutaneous PTH (1-84) injections: effects on muscle function and quality of life - HypoPT

Aarhus University Hospital, Dept of Endocrinology and Metabolism C0 个研究点目标入组 60 人开始时间: 2008年3月25日最近更新: 2021年8月2日

适应症

试验速览

暂无简介。

•Patients with hypoparathyroidism due to low endogenous plasma PTH levels, who have been treated with a 1-alfa-hydroxylated vitamin D preparation for a minimum of one years.
•Prior to start of study, participants are required to have received a daily supplement of at least 400 IU (10mcrg) of vitamin D (ergocalciferol or cholecalciferol) for at least 3 months. Subjects may be treated with ergocalciferol or cholecalciferol during a run-in period of three months before entering the study.
•TSH within reference range.
•Normal plasma magnesium level (If not, magnesium supplements may be provided during a 3 months run in period).
•Plasma calcium levels within the normal reference range or slightly below.
•Use of safe contraceptive methods (fertile women).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Severely impaired renal or hepatic function
•Previous or present malignancies affecting the skeleton
•Prior radiation therapy involving the skeleton
•Current treatment with digoxin
•Granulomatous disease
•Paget's disease of bone
•Pregnancy / planned witnin the next year
•Hospitalized due to chronic alcohol abuse
•Major medical or social problems that will be likely to preclude full participation in the study

发起方

Aarhus University Hospital, Dept of Endocrinology and Metabolism C