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

Caen University Hospital

Status and phase: Unknown; Phase 3

Conditions: Osteoporosis

Treatments: Biological: 25 OH vitamin D serum concentration measurements; Drug: Vitamin D3, 100 000 IU weekly, 4 times

Study type: Interventional

Funder types: Other

Identifiers

NCT02518763

08-090

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Vitamin D3, 100 000 IU weekly, 4 times

Experimental group

Treatment:

Biological: 25 OH vitamin D serum concentration measurements

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