The main objective is to compare the effect of immediate (or pre-existent) administration of daily calcium supplementation (1 Cacit bruisgranulaat *1000*: 1000 mg calcium) or two daily dosages of calcium + vitamin D (CaD® sachet 1000/880: 1000 mg…
ID
Source
Brief title
Condition
- Bone, calcium, magnesium and phosphorus metabolism disorders
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
In contrast to conventional X-ray, the cortical and trabecular changes in the
healing bone can be studied in vivo at the micro scale using a recently
developed low-dose HR-pQCT technique. Using this HR-pQCT technique we can gain
new insights regarding the influence of different types of medication on
(delayed or enhanced) fracture healing.
Study objective
The main objective is to compare the effect of immediate (or pre-existent)
administration of daily calcium supplementation (1 Cacit bruisgranulaat *1000*:
1000 mg calcium) or two daily dosages of calcium + vitamin D (CaD® sachet
1000/880: 1000 mg calcium + 880 IU vitamin D; and 2 CaD® sachets 500/880: 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 (XtremeCT by Scanco,
Switzerland).
The secondary objective is to compare the effect of immediate (or pre-existent)
administration of daily calcium supplementation (1 Cacit bruisgranulaat *1000*:
1000 mg calcium) or two daily dosages of calcium + vitamin D (CaD® sachet
1000/880: 1000 mg calcium + 880 IU vitamin D; and 2 CaD® sachets 500/880: 1000
mg calcium + 1760 IU vitamin D) to standard care (administration of vitamin D3
12 weeks after fracture) on fracture healing and functional outcome.
Study design
A single-blind randomized controlled trial in 100 postmenopausal women
allocated to five groups of equal group size. In a follow-up period of 1 year 6
visits are planned; visit 1 at 1-2 weeks after fracture; visit 2 at 3-4 weeks
after fracture; visit 3 at 6-8 weeks after fracture; visit 4 at 12 weeks after
fracture, visit 5 at 24 weeks post-fracture and visit 6 1 year after fracture.
Intervention
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 bruisgranulaat *1000*: 1000 mg calcium).
Group III receives immediate administration of daily calcium + low dose vitamin
D supplementation (1 CaD® sachet 1000/880: 1000 mg calcium + 880 IU vitamin D).
Group IV receives immediate administration of daily calcium + high dose vitamin
D supplementation (2 CaD® sachets 500/880: 1000 mg calcium + 1760 IU vitamin
D). Group V already uses calcium and/or vitamin D supplementation. Their dose
will be adjusted to the standard dose in accordance with the Dutch guidelines
(1 CaD® sachet 5000/880: 500 mg calcium + 880 IU vitamin D).
Study burden and risks
Patients will be assessed during six visits spanning a total period of 1 year.
Each visit takes approximately 55 minutes, so the total study time per subject
will be 330 minutes. All visits, except the fifth and sixth visit, will be
combined with the regular care visits.
During the study there will be 3 general physical examinations, 6 blood
collections, each 20ml (total amount 120 ml, for bone markers and chemistry)
and 10 HR-pQCT measurements with a total radiation dose of 100 µSv (10 times
10 µSv).
Tegelseweg 210
Venlo 5912 BL
NL
Tegelseweg 210
Venlo 5912 BL
NL
Listed location countries
Age
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
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.
11. Patients who are already selected for another trial concerning distal radius fractures.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46035.072.13 |