The objective is to assess the impact of hypoparathyroidism on quality of life and the burden of disease.
ID
Source
Brief title
Condition
- Parathyroid gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoints are quality of life in patients with hypoparathyroidism as
measured by the physical component score of the SF-36. Other endpoints are
cognitive and functional outcomes and burden of disease (eg. extra visits,
employment status, comorbidities).
Secondary outcome
The secondary objectives of this study are:
- To determine the Thyroid-Related quality of life in patients with
hypoparathyrodism
- To determine the cognitive and functional outcomes in patients with
hypoparathyrodism
- To determine the burden of disease in patients with hypoparathyroidism (eg.
Medication use, the absence of work/return to work, extra hospital visits,
comorbidities, hypoparathyroidism related laboratory parameters)
Background summary
Hypoparathyroidism is caused by absent or insufficient amounts of parathyroid
hormone. This is a relatively rare disease, but unfortunately a common
complication after thyroid surgery due to inadvertent damage to the parathyroid
glands. Although the relatively easy treatment with calcium supplementation
suggests that the burden of disease is low, Hadker et al. assessed 374 adults
with hypoparathyroidism (of which 80% was due to surgical interference) and
found that despite medical treatment, patients did not function well in their
day-to-day life. Currently, epidemiological studies are sparse and quality of
life studies are slowly advancing. The possible future treatment of these
patients with synthetic PTH renders is important to assess the burden of
disease and quality of life in a matched control study.
Study objective
The objective is to assess the impact of hypoparathyroidism on quality of life
and the burden of disease.
Study design
A prospective observational case-control study will be performed.
Study burden and risks
Patients will be asked to visit the outpatient department one time at the
beginning of inclusion. If possible, this visit will be combined with a regular
care visit. During this visit a venipuncture will be performed and in total 3
tubes of blood will be drawn. Risks associated with venipunctures are hematoma
and pain. Patients will also be asked to fill in five questionnaires at three
time points. Furthermore, patients will receive a phone call every three months
to answer questions regarding their employment status, medication,
comorbidities and extra hospital visits. There is no direct benefit for the
patients.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Patients who are aged 18 years or older at the time of inclusion
- Patients who gave informed consent
- Both cases and controls underwent (completion) thyroidectomy
- Cases have persisting hypoparathyroidism according to the previously
mentioned definition and controls do not
Exclusion criteria
- Patients who are not able to provide written informed consent
- No adequate understanding of the Dutch language
- Parathyroid disease or parathyroid surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67976.078.18 |