Role of Oxytocin in Post-menopausal Osteoporosis: Evaluation on the Population of the OPUS Cohort
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Purpose
Oxytocin is a neurohypophysial hormone involved in several central and peripheral functions including parturition, milk let-down reflex and social behaviour. In vitro and animals studies have shown growing evidence that oxytocin plays a role in bone remodeling and osteoporosis. The investigators have previously show in a small sample of post-menopausal women with severe osteoporosis (n=20) compare to healthy control (n=16) that oxytocin serum level is significantly decreased, independently of leptin and estradiol, that are known to modulate oxytocin secretion. Thus, oxytocin appears as a new interesting factor in the osteoporosis pathophysiology. The aim of the present study is to confirm the relationships between bone status, evaluated by bone mineral density and prevalent fragility fractures, body composition and oxytocin serum levels on a large population. The investigators will also determine if the relationship between bone mineral density and oxytocin is independent of estradiol and leptin in this population and evaluate the relationships between oxytocin serum level and co-morbidities such as cardiovascular diseases, depression and dementia. Theses analysis will be done on the serum already available of 1000 women of the international OPUS cohort. Bone mineral density, body composition analysis by Dual energy X-ray Absorptiometry (DXA), estradiol and clinical data are already available. The investigators will select women, aged from 55 to 79 y at the time of inclusion.
| Condition |
|---|
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Osteoporosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
- oxytocin serum levels [ Time Frame: at time = 0 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
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 (Hôpital 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.
| Estimated Enrollment: | 1000 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | October 2013 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 55 Years to 79 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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 (Hôpital 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.
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
Contacts and Locations| Contact: Véronique BREUIL, PU-PH | 0033 4 92 03 55 12 | breuil.v@chu-nice.fr |
| Contact: Vanina OLIVERI, ARC | 0033 4 92 03 42 54 | oliveri.v@chu-nice.fr |
| France | |
| Hôpital Archet 1 | Recruiting |
| Nice, France, 06200 | |
| Contact: Véronique BREUIL, PU-PH | |
| Principal Investigator: Véronique Breuil, PU-PH | |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT01192893 History of Changes |
| Other Study ID Numbers: | 10-PP-07 |
| Study First Received: | August 31, 2010 |
| Last Updated: | December 17, 2012 |
| Health Authority: | France: French Data Protection Authority |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013