Fracture Healing Assessed by HR-pQCT After Administration of Calcium and Vitamin D
NCT ID: NCT02889237
Last Updated: 2021-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2014-10-31
2020-06-18
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Standard care
Start of calcium and vitamin D3 supplementation according to standard care, i.e. 12 weeks after fracture.
No interventions assigned to this group
Calcium
Immediate administration of daily calcium supplementation (1000 mg calcium)
Calcium
Immediate administration of daily calcium supplementation for 12 weeks
Calcium and low dose vitamin D
Immediate administration of daily calcium + low dose vitamin D supplementation (1000 mg calcium + 880 IU vitamin D).
Calcium + low dose vitamin D
Immediate administration of daily calcium and low dose vitamin D (1 sachet CaD 1000/880) supplementation for 12 weeks
Calcium and high dose vitamin D
Immediate administration of daily calcium + high dose vitamin D supplementation (1000 mg calcium + 1760 IU vitamin D)
Calcium + high dose vitamin D
Immediate administration of daily calcium and high dose vitamin D (2 sachets CaD 500/880) supplementation for 12 weeks
Already on treatment with Calcium or vitamin D
Patients who are already treated with Calcium or Vitamin D.
No interventions assigned to this group
Interventions
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Calcium
Immediate administration of daily calcium supplementation for 12 weeks
Calcium + low dose vitamin D
Immediate administration of daily calcium and low dose vitamin D (1 sachet CaD 1000/880) supplementation for 12 weeks
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
50 Years
FEMALE
No
Sponsors
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VieCuri Medical Centre
OTHER
Responsible Party
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Joop P.W. van den Bergh
Prof. dr. J.P.W. van den Bergh, Endocrinologist
Principal Investigators
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J PW van den Bergh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
VieCuri Medical Centre
Locations
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VieCuri Medical Centre
Venlo, Limburg, Netherlands
Countries
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Other Identifiers
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NL46035.072.13
Identifier Type: -
Identifier Source: org_study_id