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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01192893
First received: August 31, 2010
Last updated: December 17, 2012
Last verified: August 2010
  Purpose

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.


Condition
Osteoporosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • oxytocin serum levels [ Time Frame: at time = 0 ] [ Designated as safety issue: No ]
    oxytocin serum levels, measured by radio-immuno assay, at the spine and the hip in post-menopausal women

  • bone mineral density [ Time Frame: at time = 0 ] [ Designated as safety issue: No ]
    bone mineral density, measured by dual X ray absorptiometry at the spine and the hip in post-menopausal women


Secondary Outcome Measures:
  • Estradiol serum level [ Time Frame: at time = 0 ] [ Designated as safety issue: No ]
    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 [ Time Frame: at time = 0 ] [ Designated as safety issue: No ]
    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)


Biospecimen Retention:   Samples Without DNA

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.


Estimated Enrollment: 1000
Study Start Date: July 2011
Estimated Study Completion Date: October 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/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.

  Eligibility

Ages Eligible for Study:   55 Years to 79 Years
Genders Eligible for Study:   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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192893

Contacts
Contact: Véronique BREUIL, PU-PH 0033 4 92 03 55 12 breuil.v@chu-nice.fr
Contact: Vanina OLIVERI, ARC 0033 4 92 03 42 54 oliveri.v@chu-nice.fr

Locations
France
Hôpital Archet 1 Recruiting
Nice, France, 06200
Contact: Véronique BREUIL, PU-PH         
Principal Investigator: Véronique Breuil, PU-PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
  More Information

No publications provided by Centre Hospitalier Universitaire de Nice

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01192893     History of Changes
Other Study ID Numbers: 10-PP-07
Study First Received: August 31, 2010
Last Updated: December 17, 2012
Health Authority: France: French Data Protection Authority

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 20, 2014