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

Bone Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889237
• Other study ID #: NL46035.072.13
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: June 18, 2020

Study information

• Verified date: November 2021
• Source: VieCuri Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Fracture
• Fractures, Bone

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Netherlands	VieCuri Medical Centre	Venlo	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
VieCuri Medical Centre

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone strength	Bone strength parameters will be assessed by HRpQCT	1 year
Secondary	Fracture healing		1 year
Secondary	Functional outcome assessed by PRWE	Functional outcome is assessed using Patient-Related Wrist Examination (PRWE) questionnaire	1 year
Secondary	Functional outcome assessed by QuickDASH	Functional outcome is assessed using QuickDASH questionnaires	1 year
Secondary	Functional outcome assessed using VAS for pain score	Functional outcome is assessed using VAS for pain score on Visual Analogue Scale (VAS)	1 year
Secondary	Functional outcome assessed using range of motion	Functional outcome is assessed by measuremt of range of motion of the fractured wrist	1 year