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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bone Fracture

Intervention / Treatment
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* Dietary Supplement: Calcium
* Dietary Supplement: Calcium + low dose vitamin D
* Dietary Supplement: Calcium + high dose vitamin D


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>Start of calcium and vitamin D3 supplementation according to standard care, i.e. 12 weeks after fracture. | |
| Active Comparator: Calcium<br>Immediate administration of daily calcium supplementation (1000 mg calcium) | Dietary Supplement: Calcium<br>* Immediate administration of daily calcium supplementation for 12 weeks<br>* Other names: Cacit effervescent tablet '1000';|
| Active Comparator: Calcium and low dose vitamin D<br>Immediate administration of daily calcium + low dose vitamin D supplementation (1000 mg calcium + 880 IU vitamin D). | Dietary Supplement: Calcium + low dose vitamin D<br>* Immediate administration of daily calcium and low dose vitamin D (1 sachet CaD 1000/880) supplementation for 12 weeks<br>* Other names: CaD® sachet 1000/880;|
| Active Comparator: Calcium and high dose vitamin D<br>Immediate administration of daily calcium + high dose vitamin D supplementation (1000 mg calcium + 1760 IU vitamin D) | Dietary Supplement: Calcium + high dose vitamin D<br>* Immediate administration of daily calcium and high dose vitamin D (2 sachets CaD 500/880) supplementation for 12 weeks<br>* Other names: CaD® sachets 500/880;|
| No Intervention: Already on treatment with Calcium or vitamin D<br>Patients who are already treated with Calcium or Vitamin D. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone strength | Bone strength parameters will be assessed by HRpQCT | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture healing |  | 1 year | 
| Functional outcome assessed by PRWE | Functional outcome is assessed using Patient-Related Wrist Examination (PRWE) questionnaire | 1 year | 
| Functional outcome assessed by QuickDASH | Functional outcome is assessed using QuickDASH questionnaires | 1 year | 
| Functional outcome assessed using VAS for pain score | Functional outcome is assessed using VAS for pain score on Visual Analogue Scale (VAS) | 1 year | 
| Functional outcome assessed using range of motion | Functional outcome is assessed by measuremt of range of motion of the fractured wrist | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fracture healing, Calcium supplementation, Vitamin D supplementation, HR-pQCT