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COMPLETEDPhase 1NCT01293045

Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women

* Preliminary scientific studies, in both animals and humans suggest that oral consumption of hydrolyzed collagen acts on the bone remodeling process by stimulating the activity of osteoblasts respons...

Lead sponsor: Nealth Sarl•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Nealth Sarl

Collaborators

ROUSSELOT SAS

Age

55 - 65 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy women
•Aged between 55 and 65 years
•Primary or secondary amenorrhea for at least 5 years
•BMI ≥ 20 kg/m2 and \< 27 kg/m2
•DXA \> 2.5 SD
•No history of fragility fracture bone
•Not under guardianship
•Not on hormone replacement or any osteoporotic therapy
•Covered by Social Security
•Negative serology for hepatitis B/C and HIV
•Written informed consent form signed.

Exclusion Criteria

•Bone density \< 2.5 SD (standard deviation)
•Endocrine disease
•No history of fragility fracture bone
•Dietary disorder (anorexia, bulimia)
•Hormone replacement therapy
•Inclusion in another clinical study
•Subjects receiving over 4,500 Euros in the last 12 months (including the present study)
•Subjects presenting risk of non-compliance in the opinion of the recruiting doctor.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 9, 2014Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment44

Start dateJun 2010

Last updatedApr 9, 2014

Condition

Locations shown

CRNH - Centre de Recherche sur Volontaires - Hôpital AVICENNE

Bobigny, Seine-saint-denis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2014Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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