NCT02889237

Fracture Healing Assessed by HR-pQCT After Administration of Calcium and Vitamin D

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: VieCuri Medical Centre · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bone Fracture

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Calcium	Immediate administration of daily calcium supplementation for 12 weeks
DIETARY_SUPPLEMENT	Calcium + low dose vitamin D	Immediate administration of daily calcium and low dose vitamin D (1 sachet CaD 1000/880) supplementation for 12 weeks
DIETARY_SUPPLEMENT	Calcium + high dose vitamin D	Immediate administration of daily calcium and high dose vitamin D (2 sachets CaD 500/880) supplementation for 12 weeks

Timeline

• Start date: 2014-10-01
• Primary completion: 2020-06-18
• Completion: 2020-06-18
• First posted: 2016-09-05
• Last updated: 2021-11-26

Locations

1 site across 1 country: Netherlands