OsteoporosisPhase 3VITADNCT02518763
Vitamin D Supplementation in Postmenopausal Women With Osteoporosis: Proposal of a Therapeutic Regimen in Practice
A Phase 3 study testing Vitamin D3, 100 000 IU weekly, 4 times and 25 OH vitamin D serum concentration measurements in people with Osteoporosis, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Vitamin D3, 100 000 IU weekly, 4 times and 25 OH vitamin D serum concentration measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- known sarcoidosis
- Persons under guardianship or trusteeship
- Hypercalcemia and hypercalciuria
- 25OH vitamin D levels> 50ng / ml
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Vitamin D3, 100 000 IU weekly, 4 times, 25 OH vitamin D serum concentration measurements
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3, 100 000 IU weekly, 4 timesDrug
25 OH vitamin D serum concentration measurementsBiological
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3, 100 000 IU weekly, 4 times | Experimental | Not described Receives: Drug: Vitamin D3, 100 000 IU weekly, 4 times; Biological: 25 OH vitamin D serum concentration measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25 OH vitamin D concentration
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startJun 2011
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518763
- Sponsor's protocol ID
- 08-090
- Acronym
- VITAD
- Status last verified
- Aug 2015
- First submitted
- 6 Aug 2015
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation in Postmenopausal Women With Osteoporosis: Proposal of a Therapeutic Regimen in Practice
- ClinicalTrials.gov ID
- NCT02518763
- Acronym / sponsor ID
- VITAD / 08-090
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2015 (estimated)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3, 100 000 IU weekly, 4 times | Experimental | Drug: Vitamin D3, 100 000 IU weekly, 4 times, Biological: 25 OH vitamin D serum concentration measurements |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3, 100 000 IU weekly, 4 times | Drug | Vitamin D3, 100 000 IU weekly, 4 times |
| 25 OH vitamin D serum concentration measurements | Biological | Vitamin D3, 100 000 IU weekly, 4 times |
Primary outcome
Serum 25 OH vitamin D concentration
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D3, 100 000 IU weekly, 4 times and 25 OH vitamin D serum concentration measurements in people with Osteoporosis, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25 OH vitamin D concentration (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2015.