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Trial · Observational

CompletedPhase not statedRegistry data

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

This trial does not test a peptide that PepBank tracks.

  • Measures Oxytocin, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase not stated
Enrollment
1,000 participants (actual)
Sponsor
Centre Hospitalier Universitaire de Nice · Other
Design
Not stated
Countries
1 country

France

Start
Jul 2011
Primary completion
Oct 2011
Completion
Oct 2013
First posted
1 Sept 2010 (estimated)
Last update posted
14 Aug 2015 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014
  1. Ph –

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

    NCT01192893

    Jul 2011 to Oct 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Arms1

  • Other

    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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. oxytocin serum levels

    Time frame · at time = 0

    Registry description

    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

    Registry description

    bone mineral density, measured by dual X ray absorptiometry at the spine and the hip in post-menopausal women

Secondary outcomes(2)
  1. Estradiol serum level

    Time frame · at time = 0

    Registry description

    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

    Registry description

    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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2014

8 results

Oxytocin, a new determinant of bone mineral density in post-menopausal women: analysis of the OPUS cohort.

Breuil et al. 2014The Journal of clinical endocrinology and metabolismcited by 37

PMID 24446658DOI 10.1210/jc.2013-4126PUB-24446658

Rights unknown8 results

More studies

1 study on this page

PubMed tag: none · 2015

Oxytocin and bone status in men: analysis of the MINOS cohort.

Breuil et al. 2015Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USAcited by 17

PMID 26109496DOI 10.1007/s00198-015-3201-3PUB-26109496

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 55 Years up to 79 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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