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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Subcutaneous injection of Denosumab
Stanley Dudrick's Memorial Hospital
Skawina, Poland
Improvement of bone structure: Spine
The increase of spine bone density measured by the change of Standard Deviation (SD) measured by DEXA at the level L1-L4
Time frame: 36 months
Improvement of bone structure: Femur
The increase of femur bone density measured by the change of Standard Deviation (SD) measured by DEXA at femur trochanter and shaft
Time frame: 36 months
Treatment tolerance: gastrointestinal
The presence of adverse events from gastrointestinal tract: nausea, vomiting, diarhhoea
Time frame: 36 months
Treatment tolerance: bone pain
The presence of bone pain assessed with VAS score
Time frame: 36 months
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