Role of Oxytocin in Post-menopausal Osteoporosis: Evaluation on the Population of the OPUS Cohort

Completed

• Conditions: Osteoporosis

• Registration Number: NCT01192893
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2010-08-31
• Study First Posted: 2010-09-01
• Study Start: 2011-07
• Primary Completion: 2011-10
• Study Completion: 2013-10
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-13
• Last Update Posted: 2015-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oxytocin serum levels	at time = 0	oxytocin serum levels, measured by radio-immuno assay, at the spine and the hip in post-menopausal women
bone mineral density	at time = 0	bone mineral density, measured by dual X ray absorptiometry at the spine and the hip in post-menopausal women

Secondary Outcome Measures

Name	Time	Method
Estradiol serum level	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	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)

Trial Locations

Locations (1)

Hôpital Archet 1; 🇫🇷 Nice, France