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 supplementation - Fracture healing assessed by HRpQCT in standard care and after calcium

Viecuri Medisch Centrum voor Noord-Limburg0 sites40 target enrollmentTBD

Overview

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

June 18, 2020

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Viecuri Medisch Centrum voor Noord-Limburg

•1\. Postmenopausal women older than 50 years who present themselves in clinic with a distal radius fracture due to a trauma.
•2\. Patients with a stable distal radius fracture type that is treated by cast immobilization.
•3\. 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.
•4\. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.

•1\. Patients who underwent surgery of the wrist or radius on a previous occasion on the same side or who need surgery this time.
•2\. Patients with active or suspected infection such as pneumonia or complicated urinary tract infection in the last 3 months.
•3\. Patients with malignancy or a pathological fracture in the last 12 months.
•4\. 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.
•5\. 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
•6\. 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.
•7\. The use of glucocorticoids during the last 12 months.
•8\. 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.
•9\. Patients, who as judged by the principal Investigator, are mentally incompetent or are unlikely to be compliant with the follow\-up evaluation schedule.
•10\. Patients with other severe concurrent joint involvements that can affect their outcome.