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Impact of Denosumab in the Prevention of Bone Loss in Non-menopausal Women With Anorexia Nervosa

NCT02567279 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-01-07

No results posted yet for this study

Summary

The drastic reduction of nutritional intake in anorexia nervosa(AN) alters many hormonal factors that regulate the activity of bone cells. This alteration of bone remodeling is characterized by increased bone resorption and decreased bone formation, leading to a marked reduction of bone mineral density, osteoporosis and an increased risk of fracture.

To date, there is a paucity of studies and no consensus on the management of bone loss in patients with AN. The few previous studies were performed with small samples and using short follow-up periods.

Denosumab is a fully human monoclonal antibody that binds with high specificity to human RANKL (6, 7), thereby reducing the number and activity of osteoclasts and therefore decreasing bone resorption that was found increased in patients AN.

Denosumab may transiently protect bone whilst psychonutritional management will induce a weight restoration

Conditions

  • Anorexia Nervosa

Interventions

DRUG

Denosumab subcutaneous injections

Subcutaneous injection of Denosumab 60 mg, one injection at baseline and another injection at 6 months

DRUG

Placebo subcutaneous injections

Subcutaneous injection of Placebo, one injection at baseline and another injection at 6 months

Sponsors & Collaborators

  • University Hospital, Lille

    collaborator OTHER

  • Nantes University Hospital

    collaborator OTHER

  • University Hospital, Paris

    collaborator OTHER

  • University Hospital, Rouen

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Sébastien Guillaume, MD PhD · Hôpital Lapeyronie - CHU de Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2019-01-03
Completion
2019-01-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02567279 on ClinicalTrials.gov