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CompletedNCT01192893Updated Aug 14, 2015

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

An observational study in Osteoporosis, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to female participants aged 55 Years to 79 Years. Per ClinicalTrials.gov, last updated 2015-08-14.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
55 Years to 79 Years
Sex
Female
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Study 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.

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Conditions studied

  • Osteoporosis

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03

In context

Osteoporosis

1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.

This study's enrollment of 1,000 is above the median of 180 across 461 observational studies indexed under Osteoporosis.

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Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 722 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years to 79 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (actual)
Biospecimen retention
Samples without dna

Groups and 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.

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What researchers measure

Primary outcomes

  1. oxytocin serum levels

    oxytocin serum levels, measured by radio-immuno assay, at the spine and the hip in post-menopausal women

    Time frame: at time = 0

  2. bone mineral density

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

    Time frame: at time = 0

Secondary outcomes

  1. 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)

    Time frame: at time = 0

  2. 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)

    Time frame: at time = 0

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Study locations

1 site
  • Hôpital Archet 1
    Nice, 06200, France
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References and documents

Publications

  • Breuil V, Fontas E, Chapurlat R, Panaia-Ferrari P, Yahia HB, Faure S, Euller-Ziegler L, Amri EZ, Szulc P. Oxytocin and bone status in men: analysis of the MINOS cohort. Osteoporos Int. 2015 Dec;26(12):2877-82. doi: 10.1007/s00198-015-3201-3. Epub 2015 Jun 25. PubMed 26109496 ↗
  • Breuil V, Panaia-Ferrari P, Fontas E, Roux C, Kolta S, Eastell R, Ben Yahia H, Faure S, Gossiel F, Benhamou CL, Euller-Ziegler L, Amri EZ. Oxytocin, a new determinant of bone mineral density in post-menopausal women: analysis of the OPUS cohort. J Clin Endocrinol Metab. 2014 Apr;99(4):E634-41. doi: 10.1210/jc.2013-4126. Epub 2014 Jan 21. PubMed 24446658 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01192893
Responsible party
Sponsor
First posted
Sep 1, 2010
Start date
Jul 2011
Primary completion
Oct 2011
Completion
Oct 2013
Last update
Aug 14, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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