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

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ClinicalTrials.gov Identifier: NCT02889237
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Joop P.W. van den Bergh, VieCuri Medical Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Bone Fracture Dietary Supplement: Calcium Dietary Supplement: Calcium + low dose vitamin D Dietary Supplement: Calcium + high dose vitamin D Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official 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
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard care
Start of calcium and vitamin D3 supplementation according to standard care, i.e. 12 weeks after fracture.
Active Comparator: Calcium
Immediate administration of daily calcium supplementation (1000 mg calcium)
Dietary Supplement: Calcium
Immediate administration of daily calcium supplementation for 12 weeks
Other Name: Cacit effervescent tablet '1000'

Active Comparator: Calcium and low dose vitamin D
Immediate administration of daily calcium + low dose vitamin D supplementation (1000 mg calcium + 880 IU vitamin D).
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
Other Name: CaD® sachet 1000/880

Active Comparator: Calcium and high dose vitamin D
Immediate administration of daily calcium + high dose vitamin D supplementation (1000 mg calcium + 1760 IU vitamin D)
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
Other Name: CaD® sachets 500/880

No Intervention: Already on treatment with Calcium or vitamin D
Patients who are already treated with Calcium or Vitamin D.



Primary Outcome Measures :
  1. Bone strength [ Time Frame: 1 year ]
    Bone strength parameters will be assessed by HRpQCT


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889237


Contacts
Contact: C E Wyers, PhD +31773205555 cwyers@viecuri.nl
Contact: F Heyer, MD +31773205555 f.heyer@maastrichtuniversity.nl

Locations
Netherlands
VieCuri Medical Centre Recruiting
Venlo, Limburg, Netherlands, 5912BL
Contact: F Heyer, MD    +31773205555    f.heyer@maastrichtuniversity.nl   
Contact: C E Wyers, PhD    +31773205555    cwyers@viecuri.nl   
Principal Investigator: J PW van den Bergh, MD, PhD         
Sponsors and Collaborators
VieCuri Medical Centre
Investigators
Principal Investigator: J PW van den Bergh, MD, PhD VieCuri Medical Centre

Responsible Party: Joop P.W. van den Bergh, Prof. dr. J.P.W. van den Bergh, Endocrinologist, VieCuri Medical Centre
ClinicalTrials.gov Identifier: NCT02889237     History of Changes
Other Study ID Numbers: NL46035.072.13
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Keywords provided by Joop P.W. van den Bergh, VieCuri Medical Centre:
Fracture healing
Calcium supplementation
Vitamin D supplementation
HR-pQCT

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents