Fracture healing groupPrimary outcome: to study the healing of distal radius fractures in terms of calculated bone strength based on the results of cortical and trabecular bone parameters using a novel HRpQCT technique (XtremeCT device, Scanco,…
ID
Source
Brief title
Condition
- Bone, calcium, magnesium and phosphorus metabolism disorders
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fracture healing group:
The primary objective is to study healing of distal radius fractures in
postmenopausal women in terms of alterations in micro-architecture and
calculated bone strength based on the results of cortical and trabecular bone
parameters in the first 12 weeks after fracture, using a novel high resolution
peripheral quantitative computer tomography (HRpQCT) device. Using this
technique we will develop a computer based model for fracture healing
Intervention group:
Primary outcome: to compare the effect of immediate administration of two
dosages of vitamin D (800 and 2000 IU/day) vs. standard care (administration of
vitamin D more than 12 weeks after fracture) on fracture healing and functional
outcome.
Secondary outcome
Intervention group:
Secondary outcome: to compare the healing of distal radius fractures in terms
of calculated bone strength based on the results of cortical and trabecular
bone parameters using HRpQCT (XtremeCT device, Scanco, Switzerland) using the
developed computer based model, between immediate vitamin D supplementation
(800 and 2000 IU/day) and standard care.
Background summary
Fractures of the distal radius are one of the most frequent trauma fractures.
The incidence is roughly 17 percent of all fractures. Although sometimes stated
otherwise, the outcome of the distal radius fractures is not uniformly good
regardless the treatment instituted. The cause of the poor outcome has been
related to poor restoration of anatomy and secondary loss of reduction after
initial adequate reduction. Both surgical and conservative treatment of the
distal radius fractures can be challenging since they might be associated with
complications including stiffness, loss of reduction, malunion, instability,
loss of radial length, infection, tendon rupture, sensory neuritis, and carpal
tunnel syndrome.
In regular daily practice, fracture healing is evaluated by clinical judgment
of the physician in combination with the results of conventional X-ray.
However, these evaluations do not provide detailed information with regard to
the healing process and consolidation of fractures on the level of cortical and
trabecular bone micro-structure. Until recently, the structural properties of
bone could only be studied in-vitro because of the lack of measurement
techniques and / or technical or radiation issues in-vivo. Thanks to the
development of new low radiation HRpQCT techniques (such as the XtremeCT
device) these micro-structural aspects of bone can be studied in patients.
We showed that the fracture healing process can be studied and modeled in
detail using this new technique and we demonstrated that early changes in bone
parameters measured by HR-pQCT predicted the clinical outcome at 12 weeks
post-fracture. This type of research can provide new insights regarding to the
fracture healing process in vivo and probably attribute to the understanding of
non-union of fractures and non-optimal functional outcomes as well as the
possible (positive or negative) influence of different types of medication on
(delayed or enhanced) fracture healing. It has been demonstrated that there is
a positive influence of vitamin D3 and calcium supplementation over the first
12 weeks after fracture. Whether this results in more stable fractures, or
applies to other osteogenic bone agents such as bisphosphonates and other
medications available remains to be examined.
We therefore propose this study in order to examine the ability to evaluate
fracture healing and to develop a fracture healing computer model based on
HRpQCT measurements of distal radius fractures in post-menopausal women with
and without vitamin D supplementation, with and without calcium supplementation
and with and without calcium + vitamin D supplementation.
Study objective
Fracture healing group
Primary outcome: to study the healing of distal radius fractures in terms of
calculated bone strength based on the results of cortical and trabecular bone
parameters using a novel HRpQCT technique (XtremeCT device, Scanco,
Switzerland) and to develop a computer based model for fracture healing.
Intervention group
Primary outcome: to compare the effect of immediate administration of two
dosages of vitamin D (800 and 2000 IU/day) vs. standard care (administration of
vitamin D more than 6 weeks after fracture) on fracture healing and functional
outcome.
Secondary outcome: to compare the healing of distal radius fractures between
immediate vitamin D supplementation (800 and 2000 IU/day) and standard care in
terms of calculated bone strength based on the results of cortical and
trabecular bone parameters using HRpQCT (XtremeCT device, Scanco, Switzerland)
and the developed computer based model.
Study design
A single centre consecutive, prospective cohort of 16 postmenopausal women
with a stable distal radius fracture for the evaluation of healing of distal
radius fractures and implementation of a computer based model for fracture
healing using a HRpQCT technique.
An intervention study with 30 postmenopausal women with a stable distal radius
fracture to compare the effect of immediate administration of vitamin D on
fracture healing with usual care (i.e. administration of vitamin D: 12 weeks or
more after fracture). Enrolled subjects who have been removed of the study will
be replaced.
Intervention
30 postmenopausal women with a non-operative stable distal radius fracture to
compare the effect of immediate administration of vitamin D on fracture healing
with usual care (i.e. administration of vitamin D: 12 weeks or more after
fracture).
Study burden and risks
Based on the results of literature study (see page 10 protocol) our study
proposal with vitamin D doses of 800 or 2000 IU/d is save with regard to
possible toxicity. The radiation dose of the measurements with Xtreme CT is 72
microSv, which is less than a flight to San Fransisco or a conventional CT
scan.
P Debeyelaan 25
Maastricht 6229HX
NL
P Debeyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
1.Postmenopausal women older than 50 years who present themselves in clinic with a distal radius fracture due to a trauma. 2.2. Patients with any non-operative stable distal radius fracture that is treated by cast immobilization. 3.Patients who understand the conditions of the study and are willing and able to comply with the scheduled biochemical and radiographic evaluations. 4.Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.
Exclusion criteria
1.Patients who underwent surgery of the wrist or radius on a previous occasion on the same side or who need surgery this time. 2.Patients with active or suspected infection such as pneumonia or complicated urinary tract infection in the last 3 months. 3.Patients with malignancy in the last 12 months. 4.The patient with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance during the healing period. 5.Patients with known systemic or metabolic disorders leading to progressive bone deterioration: hyperthyroidism, hyperparathyroidism, chronic kidney disease with eGFR<30 ml/min 6.Patients with an active inflammatory disease during the last year such as reumatoid arthritis, SLE, inflammatory bowel disease (M. Crohn and colitis ulcerosa) 7.The prolonged use of oral glucocorticoids during the last 6 months 8.Patients, who as judged by the principal Investigator, are mentally incompetent or are unlikely to be compliant with the follow-up evaluation schedule. 9.Patients with other severe concurrent joint involvements which can affect their outcome. 10.Patients who are already selected for another trial concerning distal radius fractures.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL33512.068.10 |
| OMON | NL-OMON21702 |