Status:
COMPLETED
Investigating the Effect of Standardized Olive Extract on Bone Turnover Markers in Postmenopausal Women
Lead Sponsor:
BioActor
Conditions:
Osteoporosis
Osteopenia
Eligibility:
FEMALE
50-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the intake of a daily dosage of standardized olive extract provides any protection against bone loss.
Detailed Description
Apart from estrogen deficiency, the early postmenopausal period is also characterised by an increasing inflammatory and oxidant status, which further contributes to the development of osteoporosis/ost...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Gender female
- Between 50-70 years of age
- At least 2 years post menopause
- Bone mineral density (BMD) \< or equal to -1.5 and \> or equal to -2.5 SD% Young Adult
- Patients with stabilised food habits
- Patients able to understand the nature of the study and able to give signed written informed consent.
Exclusion
- Patients with any diseases affecting bone tissue e.g. primary hyperparathyroidism.
- Patients during any therapy affecting bone tissue e.g. HRT, corticosteroids.
- Patients with any associated illness of sufficient severity, or clinically relevant abnormalities in the pre-study screening, which in the opinion of the investigator would make them unsuitable for inclusion in the study, e.g. severe heart failure, severe ischaemic heart disease etc.
- Planned hospitalisation (major surgery) during the study.
- Patients who have any known allergy or intolerance to any compound in the test product.
- Patients who are unwilling or unable to comply with the study protocol for any other reason.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00789425
Start Date
September 1 2008
End Date
March 1 2010
Last Update
July 13 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Osteoporosis Outpatient of the Institute of Agricultural Medicine
Lublin, Poland, 20-950