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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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2 August 2021 |
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Main ID: |
EUCTR2008-000606-36-DK |
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Date of registration:
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25/03/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treatment of hypoparathyroidism with subcutaneous PTH (1-84) injections: effects on muscle function and quality of life - HypoPT
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Scientific title:
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Treatment of hypoparathyroidism with subcutaneous PTH (1-84) injections: effects on muscle function and quality of life - HypoPT |
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Date of first enrolment:
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07/04/2008 |
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Target sample size:
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60 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000606-36 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Denmark
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Contacts
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Hypoparathyroidism
MedDRA version: 9.1
Level: LLT
Classification code 10021041
Term: Hypoparathyroidism
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Intervention(s)
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Trade Name: Preotact
Product Name: parathyroid hormone (rdna)
Product Code: SUB21634
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Parathyroideahormon
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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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.
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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.
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Primary end point(s): Maximal voluntary knee extension strength.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 28/02/2008
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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