VieCuri Medical Centre
Venlo, Limburg, 5912BL, Netherlands
NCT Number: NCT02889237
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.
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Notify Me50 year and older
Female
Interventional
Not applicable
Venlo, Limburg, 5912BL, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Immediate administration of daily calcium supplementation for 12 weeks
Other names: Cacit effervescent tablet '1000'
Immediate administration of daily calcium and low dose vitamin D (1 sachet CaD 1000/880) supplementation for 12 weeks
Other names: CaD® sachet 1000/880
Immediate administration of daily calcium and high dose vitamin D (2 sachets CaD 500/880) supplementation for 12 weeks
Other names: CaD® sachets 500/880
Time frame: 1 year
Bone strength parameters will be assessed by HRpQCT
Time frame: 1 year
Time frame: 1 year
Functional outcome is assessed using Patient-Related Wrist Examination (PRWE) questionnaire
Time frame: 1 year
Functional outcome is assessed using QuickDASH questionnaires
Time frame: 1 year
Functional outcome is assessed using VAS for pain score on Visual Analogue Scale (VAS)
Time frame: 1 year
Functional outcome is assessed by measuremt of range of motion of the fractured wrist
VieCuri Medical Centre
Other
Assessment of Fracture Healing by High-resolution Peripheral Quantitative Computed Tomography (HR-pQCT) and Bone Strength Analysis in Standard Care and After Immediate Administration of Calcium and Vitamin D Supplementation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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