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

NCT02889237 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-11-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • VieCuri Medical Centre

    lead OTHER

Principal Investigators

  • J PW van den Bergh, MD, PhD · VieCuri Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2020-06-18
Completion
2020-06-18

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02889237 on ClinicalTrials.gov