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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00730210
• Date of registration: 04/08/2008
• Prospective Registration: No
• Primary sponsor: University of Aarhus
• Public title: Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life HypoPTH
• Scientific title: Treatment of Hypoparathyroidism With Subcutaneous PTH (1-84) Injections: Effects on Muscle Function and Quality of Life
• Date of first enrolment: June 2008
• Target sample size: 62
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00730210
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Denmark

Contacts

• Name: Lars Rejnmark, MD,DrMed

• Name: Tanja Sikjær, MD

Key inclusion & exclusion 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.



Age minimum: 25 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypoparathyroidism

Intervention(s)

Drug: b:placebo

Drug: a: PTH (1-84)

Primary Outcome(s)

Increase in maximal voluntary knee extension [Time Frame: 6 months]

Secondary Outcome(s)

Effects of treatment on diurnal variations of measured biochemical indices, as assessed at the end of the treatment period [Time Frame: 24 hours at the end of the 6 month treatment period]

Bone mineral density and body composition is measured [Time Frame: 6 months]

Effects of treatment on indices of cardiovascular health (ECG and blood pressure), as measured at the end of the treatment period just prior to and 1 hour after injection of study medication. [Time Frame: at the end of the 6 months treatment period]

Balance function: Is assessed using a stadiometer (Meititur Ltd, Finland) [Time Frame: 6 months]

Effect of treatment on indices of quality of life is assessed using the SF-36v2- and WHO-Five Well-Being Index (WHO-5)-survey. [Time Frame: 6 months]

Calcium homeostasis and bone metabolism. Effects of treatment are assessed by measurements of calcitropic hormones, biochemical markers of bone turnover, and bone biopsies [Time Frame: 6 months]

Effects of treatment on muscle function are assessed through muscle biopsies, electromyographic, and by biochemical measures (muscle enzymes). [Time Frame: 6 months]

Q CT scan of hip and spine [Time Frame: 6 months]

Secondary ID(s)

EudraCT #008-000606-36)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors