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Trial · Interventional

CompletedPhase 2Registry data

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

Short name HypoPTH

NCTNCT00730210 (opens ClinicalTrials.gov in a new tab)Other idEudraCT #008-000606-36)
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
62 participants (actual)
Sponsor
University of Aarhus · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
Jun 2008
Primary completion
Aug 2010
Completion
Aug 2010
First posted
8 Aug 2008 (estimated)
Last update posted
24 Oct 2012 (estimated)
Conditions
Hypoparathyroidism

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008200920102011
  1. Ph 2

    HypoPTH

    NCT00730210

    Jun 2008 to Aug 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • a: PTH (1-84)Drug
  • b:placeboDrug

Arms2

  • Active comparator

    a: PTH (1-84) 100 ug s.c.inj. once a day

    PTH (1-84) 100 ug subcutaneous injections once a day

  • Placebo comparator

    b: placebo 100 ug s.c. inj. once a day

    placebo 100 ug sub cutaneous injection once a day

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Increase in maximal voluntary knee extension

    Time frame · 6 months

Secondary outcomes(8)

  1. Balance function: Is assessed using a stadiometer (Meititur Ltd, Finland)

    Time frame · 6 months

  2. 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

  3. Effects of treatment on muscle function are assessed through muscle biopsies, electromyographic, and by biochemical measures (muscle enzymes).

    Time frame · 6 months

  4. Bone mineral density and body composition is measured

    Time frame · 6 months

  5. 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. Q CT scan of hip and spine

    Time frame · 6 months

  7. 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

  8. 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2015

7 results

The Effect of Treatment With PTH on Undercarboxylated Osteocalcin and Energy Metabolism in Hypoparathyroidism.

Harsløf et al. 2015The Journal of clinical endocrinology and metabolismcited by 18

PMID 25955226DOI 10.1210/jc.2015-1477PUB-25955226

Rights unknown7 results
Source linkSee results (7)

Indexing hint: Randomized controlled trial · 2014

7 results

Effects of PTH(1-84) therapy on muscle function and quality of life in hypoparathyroidism: results from a randomized controlled trial.

Sikjaer et al. 2014Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USAcited by 95

PMID 24687385DOI 10.1007/s00198-014-2677-6PUB-24687385

Full text at the publisher7 results
Publisher pageSee results (7)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedGrunewald TA, Liebi M, Wittig NK, Johannes A, Sikjaer T, Rejnmark L, Gao Z, Rosenthal M, Guizar-Sicairos M, Birkedal H, Burghammer M. Mapping the 3D orientation of nanocrystals and nanostructures in human bone: Indications of novel structural features. Sci Adv. 2020 Jun 12;6(24):eaba4171. doi: 10.1126/sciadv.aba4171. eCollection 2020 Jun. PMID 32582855

Eligibility

Who could join, as posted.

Sex
All
Age
from 25 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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