N/A
ID
Bron
Aandoening
Fracture healing of distal radius fractures
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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;<br>
2. Compare the effect of immediate administration of two dosages of vitamin D3 vs. standard care on fracture healing in terms of functional outcome.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
N/A
Onderzoeksopzet
Seven visits scheduled at 1-2 (baseline), 3-4, 6-8 and 12 weeks and 6, 12 and 24 months post-fracture.
Onderzoeksproduct en/of interventie
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.
Publiek
J.P.W. Bergh, van den
Venlo 5912 BL
The Netherlands
+31 (0)77-3205555
jvdbergh@viecuri.nl
Wetenschappelijk
J.P.W. Bergh, van den
Venlo 5912 BL
The Netherlands
+31 (0)77-3205555
jvdbergh@viecuri.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiƫnten Data (IPD)
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In overige registers
Register | ID |
---|---|
NTR-new | NL3633 |
NTR-old | NTR3821 |
CCMO | NL33512.068.10 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON41626 |