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

October 23, 2012 updated by: University of Aarhus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 1alpha-hydroxylated forms of vitamin D (e.g. calcitriol or alphacalcidol) in order to relieve the symptoms associated with hypocalcaemia. However, recent studies have shown that calcium homeostasis can be well regulated by PTH replacement therapy in patients with hypoparathyroidism. It seems that PTH treatment is safe and that it even may posses advantages compared to conventional treatment with vitamin D. As the renal calcium excretion is decreased by PTH therapy, the risk of renal calcifications causing an impaired renal function may be reduced. In addition, some of the hypoparathyroid patients treated with PTH reported less fatigue and increased endurance in response to treatment. This may be due to either a better regulated (i.e. more physiological) calcium homeostasis during PTH therapy, or due to a direct effect of PTH on the neuromuscular system. Therefore, further studies are needed on the effects of PTH replacement in patients with hypoparathyroidism.

Outcome measures:

  • Muscle- and balance function: Effects of treatment on muscle strength and balance function are determined using a dynamometer and a stadiometer (Meititur Ltd, Finland). In addition, effects of treatment on muscle function are assessed through muscle biopsies, electromyographic, echocardiography, and by biochemical measures (muscle enzymes).
  • Quality of life: Effect of treatment on indices of quality of life is assessed using the SF-36v2- and the 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 iliac crest biopsies. In addition, bone mineral density and body composition is measured.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Jutland
      • Aarhus, Jutland, Denmark, 8000
        • Osteoporoseklinikken, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: a: PTH (1-84) 100 ug s.c.inj. once a day
PTH (1-84) 100 ug subcutaneous injections once a day
Drug: a: PTH (1-84)
preotact 100 microgram subcutaneous a day in 6 months
Other Names:
  • preotact
Placebo Comparator: b: placebo 100 ug s.c. inj. once a day
placebo 100 ug sub cutaneous injection once a day
Drug: b:placebo
100 microgram placebo subcutaneous a day for 6 months
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase in maximal voluntary knee extension
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Balance function: Is assessed using a stadiometer (Meititur Ltd, Finland)
Time Frame: 6 months
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
6 months
Effects of treatment on muscle function are assessed through muscle biopsies, electromyographic, and by biochemical measures (muscle enzymes).
Time Frame: 6 months
6 months
Bone mineral density and body composition is measured
Time Frame: 6 months
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
6 months
Q CT scan of hip and spine
Time Frame: 6 months
6 months
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
24 hours at the end of the 6 month treatment period
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
at the end of the 6 months treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Lars Rejnmark, MD,DrMed
  • Principal Investigator: Tanja Sikjær, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 4, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

October 24, 2012

Last Update Submitted That Met QC Criteria

October 23, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT #008-000606-36)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypoparathyroidism

Clinical Trials on a: PTH (1-84)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe