Role of Oxytocin in Post-menopausal Osteoporosis: Evaluation on the Population of the OPUS Cohort
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ClinicalTrials.gov Identifier: NCT01192893 |
Recruitment Status :
Completed
First Posted : September 1, 2010
Last Update Posted : August 14, 2015
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Condition or disease |
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Osteoporosis |
Study Type : | Observational |
Actual Enrollment : | 1000 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | October 2013 |

Group/Cohort |
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OPUS
OPUS is a prospective study of postmenopausal women recruited in the general population between April 1999 and April 2001 from five European centers (Aberdeen (UK), Berlin (Germany), Kiel (Germany), Paris (Hospital Cochin, France), and Sheffield (UK)). Investigations were approved at each institution according to the Declaration of Helsinki. Written consent was obtained from all subjects. Each center recruited approximately 500 postmenopausal women comprising 100 individuals in each 5-yr age band between 55 and 79. Ninety-nine percent of subjects were of white ethnicity.
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- oxytocin serum levels [ Time Frame: at time = 0 ]oxytocin serum levels, measured by radio-immuno assay, at the spine and the hip in post-menopausal women
- bone mineral density [ Time Frame: at time = 0 ]bone mineral density, measured by dual X ray absorptiometry at the spine and the hip in post-menopausal women
- Estradiol serum level [ Time Frame: at time = 0 ]Estradiol serum level, body composition (lean mass and fat mass), measured by dual X ray absorptiometry, clinical data (age, age of menopause, previous family history of hip fracture, personal prevalent osteoporotic fractures, prevalent cardiovascular disease, depression and dementia)
- leptin serum level [ Time Frame: at time = 0 ]Leptinserum level, body composition (lean mass and fat mass), measured by dual X ray absorptiometry, clinical data (age, age of menopause, previous family history of hip fracture, personal prevalent osteoporotic fractures, prevalent cardiovascular disease, depression and dementia)
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 55 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- post-menopausal women,
- able to undergo bone density,
- without cognitive limitation,
- Age at the time of inclusion: 55 -79y,
- Written consent.
Exclusion Criteria:
- Individuals were excluded because of inability to undergo bone densitometry or perform specified investigations or because of cognitive limitations

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192893
France | |
Hôpital Archet 1 | |
Nice, France, 06200 |
Responsible Party: | Centre Hospitalier Universitaire de Nice |
ClinicalTrials.gov Identifier: | NCT01192893 |
Other Study ID Numbers: |
10-PP-07 |
First Posted: | September 1, 2010 Key Record Dates |
Last Update Posted: | August 14, 2015 |
Last Verified: | August 2015 |
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |