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

Phase 1

• Conditions: Hypoparathyroidism; MedDRA version: 9.1Level: LLTClassification code 10021041Term: Hypoparathyroidism

• Registration Number: EUCTR2008-000606-36-DK
• Lead Sponsor: Aarhus University Hospital, Dept of Endocrinology and Metabolism C

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-25
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified