The Efficacy of Denosumab in Active Crohn's Disease
Status:
Completed
Trial end date:
2018-04-20
Target enrollment:
Participant gender:
Summary
Denosumab, a fully human monoclonal antibody to RANKL was approved for the treatment of
postmenopausal osteoporosis in June 2010. It is administered subcutaneously once every 6
months and is highly effective in reducing the risk of vertebral, non-vertebral, and hip
fracture risk. There are 3 main concepts underpinning the rationale for using Denosumab to
treat CD.
1. CD is associated with an increased risk for osteoporosis and the biology of osteoporosis
and T cell mediated inflammation, thought to be integral in CD, involve the RANKL
paradigm
2. Animal models of bone loss and colitis treated with RANKL inhibitors improve both bone
mass and colitis. A dinitrofluorobenzene sulfonic acid (DNBS) model of colitis in our
lab showed significant improvement with Denosumab treatment compared to vehicle (saline)
treatment.
3. CD is associated with an increase in mutations at the locus that encodes for RANKL The
investigators are conducting an open label pilot study of single dose Denosumab 120 mg
s.c. to patients with active Crohn's disease, with assessment of clinical response and
remission at 12 weeks.