Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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 homeostasis, bone metabolism, and body composition.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Treatments: Parathyroid Hormone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.