Hypoparathyroidism MedDRA version: 9.1 Level: LLT Classification code 10021041 Term: Hypoparathyroidism
Conditions
Interventions
Trade Name: Preotact
Product Name: parathyroid hormone (rdna)
Product Code: SUB21634
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Parathyroideahormon
Concentration unit: µg microgr
Sponsors
Aarhus University Hospital, Dept of Endocrinology and Metabolism C
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to assess whether PTH (1-84) therapy posses advantages compared to conventional treatment with active vitamin D in patients with hypoparathyroidism on muscle function, fat metabolism, quality of life, calcium homeostasis, bone metabolism, and body composition.;Secondary Objective: • Muscle function: Effects of treatment on muscle strength are determined using a dynamometer. In addition, effects of treatment on muscle function are assessed through muscle biopsies, electromyographic, and by biochemical measures (muscle enzymes). Potential effects on heart muscle function are assessed by echocardiography and ECG. • Balance function: Is assessed using a stadiometer (Meititur Ltd, Finland). • Quality of life: Effect of treatment on indices of quality of life is assessed using the SF-36v2- and WHO-Five Well-Being Index (WHO-5)-survey. • Calcium homeostasis, bone metabolism, and body composition. Effects of treatment are assessed by measurements of calcitropic hormones, biochemical markers of bone turnover, and bone biopsies. In addition, bone mineral density and body composition is measured. • Fat metabolism: Effects of treatment on fat metabolism is determined by analysis of fat biopsies. Additionally, plasma cholesterol levels are measured. ;Primary end point(s): Maximal voluntary knee extension strength. | — |
Countries
Denmark
Outcome results
None listed