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Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients (Denoz)

S

Stanley Dudrick's Memorial Hospital

Status and phase

Completed
Phase 4

Conditions

Metabolic Bone Disease

Treatments

Drug: Denosumab

Study type

Interventional

Funder types

Other

Identifiers

NCT02853539
Denozumab

Details and patient eligibility

About

Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral nutrition (HPN). Denosumab represent a new drug, which helped to prevent osteoclast. The aim of the study was to assess its value in chronic intestinal failure patients.

Full description

Low bone mineral density (BMD) is commonly reported in patients receiving home parenteral nutrition (HPN). Oral and intravenous calcium, vitamin D and bisphosphonates have been commonly used to treat BMD, but their efficiency is may be inadequate due to limited absorption and compliance. Denosumab represent a new drug, which helped to prevent osteoclast development and activation, hence decreased bone resorption in some studies. The aim of the study was to assess its value in chronic intestinal failure patients receiving HPN.

Between November 2011 and March 2013 denosumab was administered to 16 HPN patients (9 F, 7 M mean age 55.4) with intestinal failure. Regional dual-energy x-ray absorptiometry of spine and hip were performed before the therapy was initiated, and after 12 months. BMD, T-score and Z-score were measured.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • intestinal failure requiring home parental nutrition
  • bone disease measurement

Exclusion criteria

  • intestinal failure not requiring HPN
  • diagnostic modalities impossible

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Denosumab
Experimental group
Description:
One per 6 months subcutaneous injection of Denosumab (2 doses in total)
Treatment:
Drug: Denosumab
No Denosumab
No Intervention group
Description:
No intervention, just observation of HPN patients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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