Vitamin D Supplementation in Postmenopausal Women With Osteoporosis: Proposal of a Therapeutic Regimen in Practice

Osteoporosis Clinical Trial

— VITAD  

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02518763
• Other study ID #: 08-090
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 6, 2015
• Last updated: August 6, 2015
• Start date: June 2011

Study information

• Verified date: August 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Vitamin D3, 100 000 IU weekly, 4 times

Biological:
• 25 OH vitamin D serum concentration measurements

Locations

Country	Name	City	State
France	University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25 OH vitamin D concentration		4 weeks	No