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Fracture healing study.


- candidate number14270
- NTR NumberNTR3821
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jan-2013
- Secondary IDsNL33512.068.10 CCMO
- Public TitleFracture healing study.
- Scientific TitleAssessment of fracture healing by high resolution peripheral quantitative computed tomography (HR-pQCT) and bone strength analysis in standard care and after administration of vitamin D.
- ACRONYM
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedDistal radius fracture, Healing process
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2011
- planned closingdate31-dec-2013
- Target number of participants46
- InterventionsGroup 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.
- Primary outcome1. 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 outcomeUse 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.
- TimepointsFour visits scheduled at 1-2 (baseline), 3-4, 6-8 and 12 weeks post-fracture.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr J.P.W. Bergh, van den
- CONTACT for SCIENTIFIC QUERIESDr J.P.W. Bergh, van den
- Sponsor/Initiator VieCuri Medisch Centrum voor Noord-Limburg
- Funding
(Source(s) of Monetary or Material Support)
Stichting de Weijerhorst
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD28-jan-2013 - 4-feb-2013


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