1. To explore the validity and usefulness of Bone Microindentation Technique (BMT) in the assessment of bone quality in patients with osteoporosis and a spectre of bone diseases characterised with (localised) increased bone turnover. 2. To study the…
ID
Source
Brief title
Condition
- Parathyroid gland disorders
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Compare the validity of microindentation
measurements with that of BMD measurements as predictor for bone strength as
translated by prevalent fractures in the case of patients with osteoporosis
Secondary outcome
.to evaluate the ability of BMT measurements in patients treated with
Bisphosphonates, particularly in the longterm, and to predict the role of local
increasement in bone turnover in altering bone quality in localised bone
diseases such as Paget disease of bone and fibrous dysplasia.
Background summary
Low bone mass is not the only determinant of bone fragility and the strength
and integrity of the skeleton depend also on other properties of the bone
tissue, collectively termed bone quality. There is currently no available
method to assess the mechanical competence of bone in humans in vivo.
It is known that patients who receive treatment with anti-osteoporosis
medication sustain less fractures compared to those who receive other treatment
than anti-osteoporosis medication. However, the increase in bone mass as
measured by DXA only explains 30% of the decrease in fracture risk, indicating
that other component of bone strength also signficantly contribute to this
decrease in fracture risk.
Study objective
1. To explore the validity and usefulness of Bone Microindentation Technique
(BMT) in the assessment of bone quality in patients with osteoporosis and a
spectre of bone diseases characterised with (localised) increased bone
turnover.
2. To study the relationship between known determinants bone strength, such as
Bone mineral densitymeasurement as measured by DXA (BMD) and biochemical
markers of bone turnover and the BMT .
3. To assess the validity and usefulness of BMT in the follow up of
osteoporosis patients started on anti-osteoporotic medication for 18-24 months.
4. To assess the changes in BMT in patients who received other treatments than
anti-osteoporotic medication 18-24 months after treatment initiation.
Study design
Case-Control study
Prospective follow-up
Study burden and risks
Except for the additional measurement of microindentation, all laboratory and
radiological investigations are part of the routine evaluation of patients. No
extra visit to the outpatient clinic will be required. The microindentation
measurement will be performed during the regular, preplanned appointment at the
outpatient clinic. The time required for the BMT measurement is 10 minutes, the
procedure is performed under local anesthesia and is associated with minimal
discomfort for the patient.
albinusdreef 2
leiden 2332 AC
NL
albinusdreef 2
leiden 2332 AC
NL
Listed location countries
Age
Inclusion criteria
>18 years with osteoporosis, osteopenia, with and without fractures or normal bone mass with fractures or metabolic bone diseases
Exclusion criteria
* Active infection of the measurement site.
* Recent fracture of the tibia
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 | NL42277.058.12 |