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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 supplementation

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41489
Enrollment
100
Registered
2013-12-17
Start date
2014-11-28
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

distal radius fracture wrist fracture

Interventions

Group I receives standard care, i.e. start of administration of vitamin D3 12 weeks after fracture (control). Group II receives immediate administration of daily calcium supplementation (1 Cacit bru

Sponsors

Viecuri Medisch Centrum voor Noord-Limburg
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The main study parameters are the changes in cortical and trabecular bone parameters that will be assessed by HR-pQCT and the changes in estimated bone strength and stiffness as calculated in the µFEA.

Secondary

MeasureTime frame
The secondary study parameters are the standard clinical and functional outcomes that are obtained using the PRWE and QuickDASH questionnaires, the pain score using VAS and the range of motion assessment. Furthermore, blood serum markers for bone formation and resorption will be measured.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)