Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years

Osteoporosis Clinical Trial

— AMOS  

Official title:

Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years and Relationship Between Bone Loss and Adipokines.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02891356
• Other study ID #: 2011_38
• Secondary ID: 2012-A01009-34
• Status: Recruiting
• Start date: July 2013
• Est. completion date: July 2022

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: Isabelle LEGROUX, MD
• Email: isabelle.legroux[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and adipokines that either stimulate or inhibit adjacent osteoblasts. This study consist to explore the relationship in anorexia nervosa patients with change in bone mineral density and adipokines like leptin, adiponectin and Préf-1 Bone mineral densities will be measure in 180 anorexia nervosa patients at inclusion and every two years during 6 years.It is assessed blood and urinary calcium and phosphate levels, bone remodelling markers and adipokines (leptin, adiponectin and Préf-1)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• anorexia patient defined by DSM IV diagnostic criteria

Exclusion Criteria:

• patient with other psychiatric disease

• patient with other a metabolic bone disease

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Osteoporosis

Intervention

Device:
• DEXA
The Dual Energy X-ray Absorptiometry (DEXA) is a third generation multi-captor DEXA device that allow short duration measurements. It measures Bone Mineral Density (BMD) at the spine and the femoral neck

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHRU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density by Dual Energy X-ray Absorptiometry (DEXA)	measured the evolution of the bone mineral density in 180 anorexia nervosa patients and the relationship with this change and adipokine	4 years
Secondary	Incidence of osteoporotic fractures		at 2,4 and 6 years
Secondary	Adiponectin plasma concentration by ELISA	measurement of circulating biological factors predicative of changes in BMD	at 2,4 and 6 years
Secondary	Interleukin-7 plasma concentration by ELISA	measurement of circulating biological factors predicative of changes in BMD	at 2,4 and 6 years