Is the radiological, histological and biomechanical condition of bone altered after long term bisphosphonate treatment in bone that is subjected to either compressive of distractive forces.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are differences in radiological, histological and
biomechanical results between the two groups.
Secondary outcome
not applicable
Background summary
Concerning the effects of bisphosphonates in humans, little research is done in
regions that are subjected to compression and distraction forces. Almost all
human studies are done on the iliac bone, a fairly nonweightbearing area of the
human body. To get insight in the mechanism of action of bisphosphonate in a
region with high bone turnover, the femoral neck can be used, because of the
compression (calcar) and distraction (superior neck) forces.
Study objective
Is the radiological, histological and biomechanical condition of bone altered
after long term bisphosphonate treatment in bone that is subjected to either
compressive of distractive forces.
Study design
This study is a retrospective follow-up study, comparing the outcomes of
radiological, histological and biomechanical testing of bone in the femoral
neck region.
Study burden and risks
Patients from both groups will have no different workup before their operation
than normal. The only difference is a DEXA scan performed of both hips and the
lumbar spine prior to the operation of both groups. Therefore, only one extra
visit to the hospital has to be made. DEXA has a low radiation exposure and
risks are negligible.
Reinier de Graafweg 3-11
2625AD Delft
NL
Reinier de Graafweg 3-11
2625AD Delft
NL
Listed location countries
Age
Inclusion criteria
Patients who are selected to get a total hip prosthesis implanted at Reinier de Graaf Gasthuis. Patients are 18y and older, willing to participate and compos mentis.
Exclusion criteria
They do not suffer systemic disease affecting the bones or have a history of malignancy.
Design
Recruitment
metc-ldd@lumc.nl
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 | NL37068.098.11 |