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

NCT ID: NCT02518763

Last Updated: 2015-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30

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

Conditions

Osteoporosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D3, 100 000 IU weekly, 4 times

Group Type: EXPERIMENTAL

Vitamin D3, 100 000 IU weekly, 4 times

Intervention Type: DRUG

25 OH vitamin D serum concentration measurements

Intervention Type: BIOLOGICAL

Interventions

Vitamin D3, 100 000 IU weekly, 4 times

Intervention Type: DRUG

25 OH vitamin D serum concentration measurements

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital

Caen, , France

Countries

France

Other Identifiers

08-090

Identifier Type: -

Identifier Source: org_study_id