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

Primary Purpose

Osteoporosis

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Vitamin D3, 100 000 IU weekly, 4 times
25 OH vitamin D serum concentration measurements
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin D3, 100 000 IU weekly, 4 times

Arm Description

Outcomes

Primary Outcome Measures

Serum 25 OH vitamin D concentration

Secondary Outcome Measures

Full Information

First Posted
August 6, 2015
Last Updated
August 6, 2015
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02518763
Brief Title
Vitamin D Supplementation in Postmenopausal Women With Osteoporosis: Proposal of a Therapeutic Regimen in Practice
Acronym
VITAD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3, 100 000 IU weekly, 4 times
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vitamin D3, 100 000 IU weekly, 4 times
Intervention Type
Biological
Intervention Name(s)
25 OH vitamin D serum concentration measurements
Primary Outcome Measure Information:
Title
Serum 25 OH vitamin D concentration
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospital
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

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

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