No registrations found.
ID
Source
Health condition
Fracture healing of distal radius fractures
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Study the healing of distal radius fractures in terms of calculated bone strength based on the results of cortical and trabecular bone parameters using HR-pQCT and to develop a computer based model for fracture healing;
2. Compare the effect of immediate administration of two dosages of vitamin D3 vs. standard care on fracture healing in terms of functional outcome.
Secondary outcome
Use the model to compare the effect of immediate administration of two dosages of vitamin D3 vs. standard care on fracture healing in terms of bone strength.
Background summary
N/A
Study objective
N/A
Study design
Seven visits scheduled at 1-2 (baseline), 3-4, 6-8 and 12 weeks and 6, 12 and 24 months post-fracture.
Intervention
Group 1: Standard care (administration of vitamin D3 12 weeks after fracture);
Group 2: Immidiate administration of vitamin D3 (800 IU/day) 1-2 and 6-8 weeks after fracture;
Group 3: Immidiate administration of vitamin D3 (2000 IU/day) 1-2 and 6-8 weeks after fracture.
J.P.W. Bergh, van den
Venlo 5912 BL
The Netherlands
+31 (0)77-3205555
jvdbergh@viecuri.nl
J.P.W. Bergh, van den
Venlo 5912 BL
The Netherlands
+31 (0)77-3205555
jvdbergh@viecuri.nl
Inclusion criteria
1. Postmenopausal women older than 50 years with a stable distal radius fracture that is treated by immobilization with a cast;
2. Patients who understand the conditions of the study and are willing and able to comply with the scheduled evaluations and rehabilitation;
3. Patients who signed the informed consent form prior to inclusion.
Exclusion criteria
1. Patients with a history of surgery of the wrist or radius at the fractured side or who need surgery this time;
2. Patients with an active or suspected infection in the last 3 months prior to the fracture;
3. Patients with malignancy in the last 12 months;
4. Patients 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, such as: hyperthyroidism; hyperparathyroidism; chronic kidney disease with eGFR<30 ml/min; sarcoidosis; hypercalcemia;
6. Patients with an active inflammatory disease during the last 12 months, such as: reumatiod arthritis; systemic lupus erythematosus; inflammatory bowel disease;
7. The use of glucocorticoids during the last 12 months;
8. Patients who, as judged by the prinicipal investigator, are mentally incompetent or are unlikely to be compliant with the follow-up evaluation schedule.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3633 |
| NTR-old | NTR3821 |
| CCMO | NL33512.068.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON41626 |