This study is designed as a single-blind RCT in 80 postmenopausal women to compare the effect of immediate administration of daily calcium supplementation (1000 mg calcium) or two daily dosages of calcium + vitamin D (1000 mg calcium + 880 IU vitamin D or 1000 mg calcium + 1760 IU vitamin D) to standard care (administration of vitamin D3 12 weeks after fracture) in terms of calculated bone strength based on analysis of cortical and trabecular bone parameters using HR-pQCT, fracture healing and functional outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
52
Immediate administration of daily calcium supplementation for 12 weeks
Immediate administration of daily calcium and low dose vitamin D (1 sachet CaD 1000/880) supplementation for 12 weeks
Immediate administration of daily calcium and high dose vitamin D (2 sachets CaD 500/880) supplementation for 12 weeks
VieCuri Medical Centre
Venlo, Limburg, Netherlands
Bone strength
Bone strength parameters will be assessed by HRpQCT
Time frame: 1 year
Fracture healing
Time frame: 1 year
Functional outcome assessed by PRWE
Functional outcome is assessed using Patient-Related Wrist Examination (PRWE) questionnaire
Time frame: 1 year
Functional outcome assessed by QuickDASH
Functional outcome is assessed using QuickDASH questionnaires
Time frame: 1 year
Functional outcome assessed using VAS for pain score
Functional outcome is assessed using VAS for pain score on Visual Analogue Scale (VAS)
Time frame: 1 year
Functional outcome assessed using range of motion
Functional outcome is assessed by measuremt of range of motion of the fractured wrist
Time frame: 1 year
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