NCT01498341

Brief Summary

The purpose of this study is to identify the number of persons in Denmark with the diagnose hypoparathyroidism, autosomal dominant hypocalcaemia or pseudohypoparathyroidism. Also the investigators want to identify the causes and symptoms of these patients and their prognosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 1, 2014

Status Verified

January 1, 2013

Enrollment Period

9 months

First QC Date

December 20, 2011

Last Update Submit

June 30, 2014

Conditions

Hypoparathyroidism

Keywords

HypoparathyroidismEpidemiologyPrognosisSymptoms

Outcome Measures

Primary Outcomes (1)

  • Frequency of hypoparathyroidism, pseudohypoparathyroidism and autosomal dominant hypocalcaemia and its consequences

    The frequency of hypoparathyroidism, pseudohypoparathyroidism and autosomal dominant hypocalcaemia. The frequence is estimated via the National Danish Health Register. The prevalence of kidney-, cardiovascular- and neuropsychiatric disease, fertility, hospitalization required hypo- or hypercalcaemia, overall number of hospitalizations and mortality.

    One year

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population are persons with hypoparathyroidism, automalt dominant hypocalcaemia and pseudohypoparathyroidism. The population is selected via the National Danish Health Registre and the Danish Medical Registre

You may qualify if:

  • Idiopathic hypoparathyroidism
  • Pseudohypoparathyroidism
  • Autosomal dominant hypocalcaemia

You may not qualify if:

  • Chronic kidney insufficience (creatinine above 200 umol/l)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine and Endocrinology, Aarhus University Hospital, Tage-Hansens Gade

Aarhus, Region Midt, 8000, Denmark

Location

Biospecimen

Retention: NONE RETAINED

2 designs: Case-finding; Case-control

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Study Officials

  • Lars Rejnmark, DmSci, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 23, 2011

Study Start

August 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

July 1, 2014

Record last verified: 2013-01

Locations

DK(1)