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

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192893
• Other study ID #: 10-PP-07
• Status: Completed
• Phase: N/A
• First received: August 31, 2010
• Last updated: August 13, 2015
• Start date: July 2011
• Est. completion date: October 2013

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: October 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 79 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Locations

Country	Name	City	State
France	Hôpital Archet 1	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxytocin serum levels	oxytocin serum levels, measured by radio-immuno assay, at the spine and the hip in post-menopausal women	at time = 0	No
Primary	bone mineral density	bone mineral density, measured by dual X ray absorptiometry at the spine and the hip in post-menopausal women	at time = 0	No
Secondary	Estradiol serum level	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)	at time = 0	No
Secondary	leptin serum level	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)	at time = 0	No