Status:
COMPLETED
Effects of Proteins Fraction Derived From Milk on Osteoporosis Prevention
Lead Sponsor:
Soredab
Conditions:
Osteoporosis
Eligibility:
FEMALE
50-65 years
Phase:
PHASE1
Brief 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 susceptibili...
Eligibility Criteria
Inclusion
- Caucasian Female
- Natural or surgical menopause between 1 and 5 years
- Aged between 50 to 65 years
- BMI between 19 and 30 kg/m²
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT01478724
Start Date
November 1 2011
End Date
May 1 2015
Last Update
May 25 2015
Active Locations (1)
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1
Cochin hospital
Paris, France, 75014