The primary objective is to assess bone structure parameters and bone strength by high resolution peripheral quantitative CT evaluation (HRpQCT) and physical activity in relation with subsequent falls, fractures and mortality in patients with a…
ID
Source
Brief title
Condition
- Bone, calcium, magnesium and phosphorus metabolism disorders
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bone structure parameters, bone strength, physical activity, falls, subsequent
fractures and mortality.
Secondary outcome
In addition, parameters assessed during regular care will be investigated such
as clinical risk factors for fractures and osteoporosis, dietary calcium
intake, fall risk assessment, muscle strength and function, gait quality, bone
mineral density and laboratory analysis.
Background summary
The risk for a subsequent fracture is significantly higher in patients
presenting with a fracture compared to individuals without a previous fracture
and is highest within the first 2 years after the initial fracture. The risk
for a subsequent fracture is not dependent of BMD as measured by conventional
DXA. In recent studies, it has been shown that HRpQCT measurements provide
information about bone structure, bone quality and bone strength in addition to
BMD measurements. Diagnostic strategies should be focussed on bone quality and
bone strength and fall prediction in the patients at high risk for falls,
subsequent fracture and mortality such as patients with a recent fracture.
Therefore, we conduct a prospective observational study in 500 patients aged
50 years and older who present with a clinical fracture for evaluation of bone
strength, physical activity, falls, subsequent fractures and mortality during a
follow-up period of 3 years.
Study objective
The primary objective is to assess bone structure parameters and bone strength
by high resolution peripheral quantitative CT evaluation (HRpQCT) and physical
activity in relation with subsequent falls, fractures and mortality in patients
with a recent clinical fracture.
Secondary objectives are to study:
* the relation between bone strength assessed by HRpQCT and conventional bone
mineral density (BMD) measurement by Dual-energy X-ray Absorptiometry (DXA);
* the relation between falls and subsequent fractures;
* the determinants of mortality;
* the ability of standard muscle strength tests (by handgrip strength, upper
leg strength measured by MicroFet, Timed Up & Go test (TUG) and Chair Stand
Test) and gait analyses (Six-Minute Walk Test (6MWT)) to predict falls and
subsequent fractures;
* the influence of falls and subsequent fractures on quality of life.
Study design
The study is designed as a prospective observational study with a follow-up
period of 3 years.
Study burden and risks
According to regular care, patients with a recent clinical fracture are
referred by the trauma surgeon for an evaluation at the FLS (previously known
as osteoporosis outpatient clinic). At the first visit, clinical risk factors
for osteoporosis, fractures and falls are registered and additionally muscle
strength and gait tests, bone mineral density measurement (DXA) and laboratory
analysis are performed. At the second visit, patients receive the results of
the muscle strength and gait tests, bone mineral density measurement (DXA) and
laboratory analysis and when needed disorders are further analysed and patients
are being treated.
For study purposes bone strength will be measured by HRpQCT, two activity
monitors (MOX and ActivPAL3) will be attached to the upper leg for a 7-day
analysis of physical activity and an additional blood sample will be collected.
These study related procedures will be performed during the second regular care
visit at the osteoporosis outpatient clinic. During follow-up, two telephone
calls are planned at 3 and 6 months after inclusion for evaluation of quality
of life, falls and subsequent fractures. Also three follow-up visits (one, two
and three years after baseline visit), will be planned for assessment of bone
strength by HRpQCT, muscle strength and function tests, quality of life and
evaluation of falls, subsequent fractures and mortality.
Tegelseweg 210
Venlo 5912 BL
NL
Tegelseweg 210
Venlo 5912 BL
NL
Listed location countries
Age
Inclusion criteria
1. Patients aged 50 years and older with a recent fracture that is being evaluated at the FLS at VieCuri MC.
2. Patients who understand the conditions of the study and are willing and able to comply with the scheduled study procedures
3. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.
Exclusion criteria
1. Patients with malignancy metastatic to the bone.
2. Patients with osteomyelitis.
3. Patients with fractures due to failure of a prosthesis.
4. Patients, who as judged by the Principal Investigator, are mentally incompetent. Patients who are compos mentis and understand the patient information, will not be considered mentally incompetent.
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 | NL45707.072.13 |