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Completed

NCT Number: NCT02889237

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

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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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

VieCuri Medical Centre

Venlo, Limburg, 5912BL, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal women older than 50 years who present themselves in clinic with a distal radius fracture due to a trauma.
  • Patients with a stable distal radius fracture treated by cast immobilization.
  • Patients who understand the conditions of the study and are willing and able to comply with the scheduled biochemical and radiographic evaluations and the prescribed rehabilitation.
  • Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.

Exclusion criteria

  • Patients who underwent surgery of the wrist or radius on a previous occasion on the same side or who need surgery this time.
  • Patients with active or suspected infection such as pneumonia or complicated urinary tract infection in the last 3 months.
  • Patients with malignancy or a pathological fracture in the last 12 months.
  • Patients with a neuromuscular or neurosensory deficit, e.g. Parkinson's disease, which would limit the ability to assess the performance during the healing period.
  • 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,
  • Patients with an active inflammatory disease during the last year such as rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, e.g. Crohn's disease and ulcerative colitis.
  • The use of glucocorticoids during the last 12 months.
  • Patients with an allergy to calcium, calcium carbonate, cholecalciferol, aspartame, citric-acid, lactose, dimethicone, methylcellulose, sorbic acid, macrogole, polyvidone, mannitol, orange flavour, natriumsaccharine, starch or sucrose.
  • Patients, who as judged by the principal Investigator, are mentally incompetent or are unlikely to be compliant with the follow-up evaluation schedule.
  • Patients with other severe concurrent joint involvements that can affect their outcome.
  • Patients who are already selected for another trial concerning distal radius fractures.

Treatment and study plan

Calcium

Dietary Supplement

Immediate administration of daily calcium supplementation for 12 weeks

Other names: Cacit effervescent tablet '1000'

Calcium + low dose vitamin D

Dietary Supplement

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

Calcium + high dose vitamin D

Dietary Supplement

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

Primary outcomes

  1. Bone strength

    Time frame: 1 year

    Bone strength parameters will be assessed by HRpQCT

Secondary outcomes

  1. Fracture healing

    Time frame: 1 year

  2. Functional outcome assessed by PRWE

    Time frame: 1 year

    Functional outcome is assessed using Patient-Related Wrist Examination (PRWE) questionnaire

  3. Functional outcome assessed by QuickDASH

    Time frame: 1 year

    Functional outcome is assessed using QuickDASH questionnaires

  4. Functional outcome assessed using VAS for pain score

    Time frame: 1 year

    Functional outcome is assessed using VAS for pain score on Visual Analogue Scale (VAS)

  5. Functional outcome assessed using range of motion

    Time frame: 1 year

    Functional outcome is assessed by measuremt of range of motion of the fractured wrist

Sponsors and collaborators

Lead sponsor

VieCuri Medical Centre

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Sep 5, 2016
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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