Fracture Healing Assessed by HR-pQCT After Administration of Calcium and Vitamin D
Bone Fracture
About this trial
This is an interventional other trial for Bone Fracture focused on measuring Fracture healing, Calcium supplementation, Vitamin D supplementation, HR-pQCT
Eligibility 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.
Sites / Locations
- VieCuri Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
No Intervention
Active Comparator
Active Comparator
Active Comparator
No Intervention
Standard care
Calcium
Calcium and low dose vitamin D
Calcium and high dose vitamin D
Already on treatment with Calcium or vitamin D
Start of calcium and vitamin D3 supplementation according to standard care, i.e. 12 weeks after fracture.
Immediate administration of daily calcium supplementation (1000 mg calcium)
Immediate administration of daily calcium + low dose vitamin D supplementation (1000 mg calcium + 880 IU vitamin D).
Immediate administration of daily calcium + high dose vitamin D supplementation (1000 mg calcium + 1760 IU vitamin D)
Patients who are already treated with Calcium or Vitamin D.