Clinical trial NCT02889237: Fracture Healing Assessed by HR-pQCT After Administration of Calcium and Vitamin D
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Fracture
Keywords: Fracture healing
Calcium supplementation
Vitamin D supplementation
HR-pQCT
Lead sponsor: VieCuri Medical Centre
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 52
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


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.

Primary outcomes:
measure: Bone strength
timeFrame: 1 year
Secondary outcomes:
measure: Fracture healing
timeFrame: 1 year
measure: Functional outcome assessed by PRWE
timeFrame: 1 year
measure: Functional outcome assessed by QuickDASH
timeFrame: 1 year
measure: Functional outcome assessed using VAS for pain score
timeFrame: 1 year
measure: Functional outcome assessed using range of motion
timeFrame: 1 year
Other outcomes:
Locations:
city: Venlo
country: Netherlands
facility: VieCuri Medical Centre
state: Limburg
Study officials:
affiliation: VieCuri Medical Centre
name: J PW van den Bergh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: