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Completed

NCT Number: NCT01192893

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

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.

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Key information

Age range

55 year–79 year

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Archet 1

Nice, 06200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2013
First posted
Sep 1, 2010
Registry last updated
Aug 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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