Status:
COMPLETED
Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life
Lead Sponsor:
University of Aarhus
Conditions:
Hypoparathyroidism
Eligibility:
All Genders
25-80 years
Phase:
PHASE2
Brief Summary
The aim of the study is to assess whether PTH (1-84) therapy posses advantages compared to conventional treatment in patients with hypoparathyroidism on muscle function, quality of life, calcium homeo...
Detailed Description
Hypoparathyroidism is one of the only hormonal insufficiency states that is usually not treated by replacing the missing hormone. Currently, Standard therapy includes treatment with calcium and an 1al...
Eligibility Criteria
Inclusion
- A low endogenous PTH production as verified by low plasma levels of intact PTH, necessitating treatment with 1alpha-hydroxylated vitamin D analogs.
- At least one years of continuous alphacalcidol, calcitriol, or dihydrotachysterol treatment prior to study entry.
- Prior to start of study, participants are required to have received a daily supplement of at least 400 IU (10 microgram) of vitamin D (ergocalciferol or cholecalciferol) for at least 3 months or 25hydroxyvitamin D levels above 50 nmol/l. Subjects may be treated with ergocalciferol or cholecalciferol during a run-in period of three months before entering the study.
- 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 (P-Ca ionized 1.00 to 1.30).
- Use of safe contraceptive methods (fertile women).
- Speak and read Danish.
Exclusion
- Known allergic reactions to any of the compounds in the trial medication.
- Severely impaired renal function (plasma creatinine \> 200 micromol/l).
- Severely impaired hepatic function (Plasma alanine aminotransferase (ALAT) \> 100 U/l and/or alkaline phosphatase \> 400 U/l).
- Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy).
- Prior radiation therapy involving the skeleton.
- Current treatment with raloxifene, calcitonin, systemic corticosteroids above 5 mg a day, fluoride, lithium, PTH, or digoxin.
- Treatment with anticonvulsant's (within the last 2 years).
- Immobilization (more than two week within the last 6 months).
- Granulomatous disease.
- Paget's disease of bone.
- Pregnancy / planned within the next year. Hospitalized due to chronic drug or alcohol abuse. Severe malabsorption syndrome.
- Major medical or social problems that will be likely to preclude participation for one year.
- Unwillingness to participate.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00730210
Start Date
June 1 2008
End Date
August 1 2010
Last Update
October 24 2012
Active Locations (1)
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1
Osteoporoseklinikken, Aarhus University Hospital
Aarhus, Jutland, Denmark, 8000