Osteoporosis Clinical Trial
— OSTRIAOfficial title:
Epidemiological, Observational, Multicenter Clinical Trial
Verified date | May 2013 |
Source | Elpen Pharmaceutical Co. Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: National Organization of Medicines |
Study type | Observational |
Osteoporosis is the most common disease of bone and characterized firstly by low bone mass and secondly, impaired bone microarchitecture structure resulting in reduced strength and increased risk of fracture. Osteoporosis is divided into: primary (Postmenopausal Osteoporosis Osteoporosis & elderly and senile osteoporosis) and secondary. The most common form is postmenopausal osteoporosis. It occurs in women after menopause and is associated with decreased estrogen production, which normally occurs at this age women Osteoporosis usually occurs after age 50, it is very common in women than in men, and its frequency increases with advancing age.
Status | Completed |
Enrollment | 5500 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Females - Postmenopausal women - Outpatients screened for osteoporosis - Women > 45 years - Women < 45 years under menopause - Women obtained their consent to be measured Exclusion Criteria: - Premenopausal females - Women without any symptom of menopause - Women not obtained their consent to be measured |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Greece | Iaso Hospital of Athens, Center of Endocrinology and Bone Metabolism | Athens | Kifisias Avenue, 37-39, Maroussi |
Lead Sponsor | Collaborator |
---|---|
Elpen Pharmaceutical Co. Inc. |
Greece,
Ikeda Y, Iki M, Morita A, Aihara H, Kagamimori S, Kagawa Y, Matsuzaki T, Yoneshima H, Marumo F; JPOS Study Group. Age-specific values and cutoff levels for the diagnosis of osteoporosis in quantitative ultrasound measurements at the calcaneus with SAHARA in healthy Japanese women: Japanese population-based osteoporosis (JPOS) study. Calcif Tissue Int. 2002 Jul;71(1):1-9. Epub 2002 Jun 20. — View Citation
Kanis JA. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: synopsis of a WHO report. WHO Study Group. Osteoporos Int. 1994 Nov;4(6):368-81. — View Citation
Magkos F, Manios Y, Babaroutsi E, Sidossis LS. Quantitative ultrasound calcaneus measurements: normative data for the Greek population. Osteoporos Int. 2005 Mar;16(3):280-8. Epub 2004 Jul 6. — View Citation
McClung M. Difference in Distribution of T-scores Among Bone Density Tests in Postmenopausal Women. Bone Vol. 23, (5S), pg. S193, 1998.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Osteoporosis Indicator | T-score per female as measured by Holofic Sahara Instrument | 1 year | No |
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