OsteoporosisPhase 2NCT00663221
Study of the Osteoprotector Effects of a Milk Product Based on Anthocyans and Enriched in Calcium and Vitamin D
A Phase 2 study testing Anthocyans, Calcium and Vitamin D in people with Osteoporosis, run by Elvir SAS at 1 site in France.
Trial summary
We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone reshaping in menopausal women. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Anthocyans, Calcium and Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to not given
- Phase
- Phase 2
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Aged between 50 and 65 years
- Between 1 and 5 years menopause
- IMC between 19 and 30 kg/m²
Who cannot join
- Medical Treatment for bone metabolism
- Vitamin D not including in the range of 20nmoles<25(OH)<100nmoles/l
- Vegan and vegetarian diet
- Regular consumption of food supplementary benefits
- Lactose intolerance
- While dieting
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone reshaping in menopausal women.
- Conditions
- Osteoporosis
- Being tested
- Anthocyans, Calcium and Vitamin D, placebo
- Keywords
- Osteoporosis prevention
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthocyans, Calcium and Vitamin DDietary supplement
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
| 2 | Experimental | Not described Receives: Dietary Supplement: Anthocyans, Calcium and Vitamin D |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startMar 2008
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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elvir SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663221
- Sponsor's protocol ID
- LC2 Atlas
- Status last verified
- Jul 2009
- First submitted
- 14 Apr 2008
- Last updated
- 7 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Osteoprotector Effects of a Milk Product Based on Anthocyans and Enriched in Calcium and Vitamin D
- ClinicalTrials.gov ID
- NCT00663221
- Acronym / sponsor ID
- LC2 Atlas
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Elvir SASIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Clermont-Ferrand
- Study start
- Mar 2008
- First posted
- 22 Apr 2008 (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.
We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone reshaping in menopausal women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: placebo |
| 2 | Experimental | Dietary Supplement: Anthocyans, Calcium and Vitamin D |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women
- Aged between 50 and 65 years
- Between 1 and 5 years menopause
- IMC between 19 and 30 kg/m²
Key exclusion criteria (6 listed)
- Medical Treatment for bone metabolism
- Vitamin D not including in the range of 20nmoles<25(OH)<100nmoles/l
- Vegan and vegetarian diet
- Regular consumption of food supplementary benefits
- Lactose intolerance
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 |
|---|---|---|
| Anthocyans, Calcium and Vitamin D | Dietary supplement | 2 |
| placebo | Dietary supplement | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
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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 2 study testing Anthocyans, Calcium and Vitamin D in people with Osteoporosis, run by Elvir SAS 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 7 Jul 2009. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 7 Jul 2009.