Denosumab Counteracts Metabolic Bone Disease in Chronic Intestinal Failure Patients: A Randomized, Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Improvement of bone structure: Spine
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •intestinal failure requiring home parental nutrition
- •bone disease measurement
Exclusion Criteria
- •intestinal failure not requiring HPN
- •diagnostic modalities impossible
Arms & Interventions
Denosumab
One per 6 months subcutaneous injection of Denosumab (2 doses in total)
Intervention: Denosumab (Drug)
Outcomes
Primary Outcomes
Improvement of bone structure: Spine
Time Frame: 36 months
The increase of spine bone density measured by the change of Standard Deviation (SD) measured by DEXA at the level L1-L4
Improvement of bone structure: Femur
Time Frame: 36 months
The increase of femur bone density measured by the change of Standard Deviation (SD) measured by DEXA at femur trochanter and shaft
Secondary Outcomes
- Treatment tolerance: bone pain(36 months)
- Treatment tolerance: gastrointestinal(36 months)
Investigators
Stanislaw Klek
Head of the Department
Stanley Dudrick's Memorial Hospital