The objective of the study is to find out whether the concentrations of mineral srelevant to bone metabolism correlate between bone and nails.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
concentrations of Al, As, Ca, Co, Cr, Fe, Hg, K, Mg, Mn, Zn in both bone and
toenail
Secondary outcome
correlation between concentrations of elements mentioned in the hip and BMD
value of the DEXA
Background summary
About 800.000 patients are known with osteoporosis and an increased fracture
risk in the Netherlands. More than 80.000 fractures per year can be attributed
to fragile bones. This not only causes pain, discomfort, sometimes physical
limitations but also absence of work, admissions to hospitals, surgery,
rehabilitation programs and costs for society. In the elderly there is even a 1
year mortality rate of 25% after a hip fracture. Currently osteoporosis is
diagnosed after a fracture and there are hardly programs actively applied to
identify high risk patients. Diagnosis is made by DEXA scanning and although
more accurate techniques are available they are time consuming, sometimes
invasive and costly, so not suited for routine use. So called bone markers in
blood and urine have limited value. Best information can be obtained by bone
biopsy, but this is a painful, invasive procedure and therefore not used in
clinical practice except for research. So there is a need for a simple, non
invasive and reliable method to study bone status and bone mineralization, that
can be used in research, practice and that can monitor changes induced by
interventions (food, drugs).
Nails show some resemblance to bone and are located near bone sometimes having
the same vascular supply system. Therefore it can be hypothesized that changes
in the supply of minerals to bone will also be reflected in the nail. Some
studies have looked at minerals in nail and their correlation to bone status,
but their outcomes are conflicting. No study has been performed that compared
within the same individual the mineral content of the nail and bone. This is
the rationale for the NIRVANA study to do exactly that.
Study objective
The objective of the study is to find out whether the concentrations of mineral
srelevant to bone metabolism correlate between bone and nails.
Study design
The study will be performed in patients on the waiting list for hip replacement
surgery. They have been seen on the out patient department of orthopedic
surgery and are informed by the surgeon about the study. They will get
information about the study and will be invited to come to the research
department for further information. In case they decide to participate they
sign an informed consent letter and nailclipping will be performed. Furthermore
a questionnaire will be filled in. At the time of the planned surgery a part of
the removed hip bone will be taken and will be send together with the nail to
the RID department of the Technical University Delft. Minerals will be measured
there with instrumental neutron activation analysis.
Study burden and risks
Apart from the nailclipping and an extra visit to the hospital taking about 30
minutes there are no extra burdens for the patient related to this study
maatweg 3
amersfoort 3813TZ
NL
maatweg 3
amersfoort 3813TZ
NL
Listed location countries
Age
Inclusion criteria
planned for hip replacement
Exclusion criteria
other bone disorders than osteoporosis
with congenital or acquired nail disorders
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 | NL60581.100.17 |