OsteoporosisPhase 1NCT01478724
Effects of Proteins Fraction Derived From Milk on Osteoporosis Prevention
A Phase 1 study testing Milk proteins fraction in people with Osteoporosis, run by Soredab at 1 site in France.
Trial summary
Osteoporosis is defined as a systemic skeletal disease characterised by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Milk proteins fraction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 291 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to May 2015
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian Female
- Natural or surgical menopause between 1 and 5 years
- Aged between 50 to 65 years
- BMI between 19 and 30 kg/m²
Who cannot join
- Medications: oral steroidal anti-inflammatory, anti-osteoporotic treatment, hormone replacement therapy
- Low bone mineral density (T-score<-3
- Diseases affecting bone metabolism(Paget's disease, Cushing's disease, thyroid disease...)
- Intolerance or allergy to milk proteins and allergy to soy or soy lecithin
- Heavy smoking
- Excessive alcohol drinking
- Intensive sports practice according to the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Proteins Fraction Derived From Milk on Bone Mineral Density and Bone Metabolism in Healthy Postmenopausal Women
Osteoporosis is defined as a systemic skeletal disease characterised by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Osteoporosis is a serious public health problem that is responsible for approximately 3 million women with osteoporosis in France, with approximately 150,000 cases per year occurring in vertebral fractures, of which only one third would be diagnosed and 50,000 hip fractures (causing death in 20% of cases). The frequency of the disease increases with age, particularly among women: 10% among women aged 60 years and 20% among women aged 65 and 40% among women aged 75. At menopause, oestrogen deficiency causes alterations of the immune system, decreased bone formation, microarchitectural deterioration and a decrease in bone mass. Various factors may contribute to this decrease in bone density such as diet, lifestyle, or the genetic background.
According to prospective studies, an overexpression of 135% of hip fractures is expected at European level in 50 years. Therefore, it is interesting to develop new prevention approaches aimed at maintaining the healthy aging population. Nutritional researches can consider setting up a real prevention.
Read more
Studies suggest that specific milk protein fraction contain factors able to promote bone formation, inhibit bone resorption in vitro. In animal model, they showed that the specific fraction prevents bone loss in aged ovariectomised rats by reducing bone resorption. Furthermore, in human volunteers, a supplementation with the specific milk protein fraction maintains balanced bone remodelling and increase bone mineral density. For example, in healthy postmenopausal women, it has been reported that a mean rate of gain of lumbar BMD in the MPF group (1.21%) was significantly higher than in placebo group (-0.66%; p<0.05).
The objective of this study is to assess the efficacy of daily consumption of the milk proteins fraction on bone mineral density improvement in healthy postmenopausal women.
- Conditions
- Osteoporosis
- Being tested
- Milk proteins fraction
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk proteins fractionDietary supplement
capsules, one per day, 24 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Animal proteins Receives: Dietary Supplement: Milk proteins fraction |
| Milk protein fraction dose 1 | Experimental | Not described Receives: Dietary Supplement: Milk proteins fraction |
| Milk protein fraction dose 2 | Experimental | Not described Receives: Dietary Supplement: Milk proteins fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
lumbar spine bone mineral density
Measured: 24 months
Secondary outcomes (3)
femoral bone mineral density
Measured: 12 and 24 months
lumbar spine bone mineral density
Measured: 12 months
bone remodelling biomarkers
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2015
- Study completionMay 2015
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soredab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Roux, PUPH, Principal investigator, Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478724
- Sponsor's protocol ID
- SORBONE
- Status last verified
- May 2015
- First submitted
- 21 Nov 2011
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proteins Fraction Derived From Milk on Bone Mineral Density and Bone Metabolism in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01478724
- Acronym / sponsor ID
- SORBONE
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- SoredabIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Nov 2011 (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.
Osteoporosis is defined as a systemic skeletal disease characterised by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Osteoporosis is a serious public health problem that is responsible for approximately 3 million women with osteoporosis in France, with approximately 150,000 cases per year occurring in vertebral fractures, of which only one third would be diagnosed and 50,000 hip fractures (causing death in 20% of cases). The frequency of the disease increases with age, particularly among women: 10% among women aged 60 years and 20% among women aged 65 and 40% among women aged 75. At menopause, oestrogen deficiency causes alterations of the immune system, decreased bone formation, microarchitectural deterioration and a decrease in bone mass. Various factors may contribute to this decrease in bone density such as diet, lifestyle, or the genetic background.
According to prospective studies, an overexpression of 135% of hip fractures is expected at European level in 50 years. Therefore, it is interesting to develop new prevention approaches aimed at maintaining the healthy aging population. Nutritional researches can consider setting up a real prevention.
Studies suggest that specific milk protein fraction contain factors able to promote bone formation, inhibit bone resorption in vitro. In animal model, they showed that the specific fraction prevents bone loss in aged ovariectomised rats by reducing bone resorption. Furthermore, in human volunteers, a supplementation with the specific milk protein fraction maintains balanced bone remodelling and increase bone mineral density. For example, in healthy postmenopausal women, it has been reported that a mean rate of gain of lumbar BMD in the MPF group (1.21%) was significantly higher than in placebo group (-0.66%; p<0.05).
The objective of this study is to assess the efficacy of daily consumption of the milk proteins fraction on bone mineral density improvement in healthy postmenopausal women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Milk proteins fractionAnimal proteins |
| Milk protein fraction dose 1 | Experimental | Dietary Supplement: Milk proteins fraction |
| Milk protein fraction dose 2 | Experimental | Dietary Supplement: Milk proteins fraction |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Caucasian Female
- Natural or surgical menopause between 1 and 5 years
- Aged between 50 to 65 years
- BMI between 19 and 30 kg/m²
Key exclusion criteria (7 listed)
- Medications: oral steroidal anti-inflammatory, anti-osteoporotic treatment, hormone replacement therapy
- Low bone mineral density (T-score<-3
- Diseases affecting bone metabolism(Paget's disease, Cushing's disease, thyroid disease...)
- Intolerance or allergy to milk proteins and allergy to soy or soy lecithin
- Heavy smoking
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 |
|---|---|---|
| Milk proteins fractioncapsules, one per day, 24 months | Dietary supplement | Milk protein fraction dose 1, Milk protein fraction dose 2, Placebo |
Primary outcome
lumbar spine bone mineral density
Time frame: 24 months
3 secondary outcomes
femoral bone mineral density
Time frame: 12 and 24 months
lumbar spine bone mineral density
Time frame: 12 months
bone remodelling biomarkers
Time frame: 6 and 12 months
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 25 May 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.
Christian Roux, PUPH principal investigator
Cochin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Milk proteins fraction in people with Osteoporosis, run by Soredab 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 7 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 25 May 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
lumbar spine bone mineral density (time frame: 24 months). 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 25 May 2015.