Osteoporosis
Conditions
Brief summary
The vitamin D deficiency (25OHD) is very common and affects about 80% of the population of French osteoporotic women over 50 years \[5\]. It contributes significantly to bone fragility and consequently the risk of fracture. To remedy this deficit, it is necessary to provide a suitable and sustainable supplementation. Changes in vitamin D deficiency ranging from undetectable to a 25OHD value very close to 30ng / ml lead to differences in therapeutic regimens, specific to each clinician in the absence of precise data in the literature. No consensus on supplementation dosages and methods have been proposed so far. Also, given the frequency of vitamin D deficiency including osteoporosis observed in the population, it became necessary to establish a single, uniform regimen for all patients with osteoporosis
Interventions
DRUGVitamin D3, 100 000 IU weekly, 4 times
BIOLOGICAL25 OH vitamin D serum concentration measurements
Sponsors
University Hospital, Caen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women ≥ 50 years * Osteoporosis with BMD T-score ≤ -2.7DS -2.5DS to at least one of the two main sites analyzed, with or without fracture * having signed an informed consent
Exclusion criteria
* Taking a loading dose of vitamin D in the last six months (a daily intake in combination with calcium will not be a cause of exclusion but should be discontinued during the study). * Taking an osteoporosis treatment combined with vitamin D in the same tablet (or Adrovance Fosavance \* \*) * Treatment with thiazide diuretic * Known malabsorption (celiac disease) * Scalable Endocrine disorders: hyperthyroidism, hyperparathyroidism, hypoparathyroidism. * Persistent or nephrolithiasis occurred in the previous 5 years * known sarcoidosis * Persons under guardianship or trusteeship * Hypercalcemia and hypercalciuria * 25OH vitamin D levels\> 50ng / ml
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum 25 OH vitamin D concentration | 4 weeks |
Countries
France
Outcome results
None listed