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

Phase 3

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

• Registration Number: NCT02518763
• Lead Sponsor: University Hospital, Caen

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Status Verified: 2015-08
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-06
• Last Update Submitted: 2015-08-06
• Study First Posted: 2015-08-10
• Last Update Posted: 2015-08-10
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D3, 100 000 IU weekly, 4 times	Vitamin D3, 100 000 IU weekly, 4 times	-
Vitamin D3, 100 000 IU weekly, 4 times	25 OH vitamin D serum concentration measurements	-

Primary Outcome Measures

Name	Time	Method
Serum 25 OH vitamin D concentration	4 weeks

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Caen, France