Overview

This trial is active, not recruiting.

Condition osteoporosis
Treatments vitamin d3, 100 000 iu weekly, 4 times, 25 oh vitamin d serum concentration measurements
Phase phase 3
Sponsor University Hospital, Caen
Start date June 2011
End date December 2015
Trial size 120 participants
Trial identifier NCT02518763, 08-090

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
vitamin d3, 100 000 iu weekly, 4 times
25 oh vitamin d serum concentration measurements

Primary Outcomes

Measure
Serum 25 OH vitamin D concentration
time frame: 4 weeks

Eligibility Criteria

Female participants at least 50 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University Hospital, Caen.