Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Denosumab Counteracts Metabolic Bone Disease in Chronic Intestinal Failure Patients: A Randomized, Controlled Clinical Trial

Conditions
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Metabolic Bone Disease

Intervention / Treatment
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* Drug: Denosumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: intestinal failure requiring home parental nutrition bone disease measurement Exclusion Criteria: intestinal failure not requiring HPN diagnostic modalities impossible

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Denosumab<br>One per 6 months subcutaneous injection of Denosumab (2 doses in total) | Drug: Denosumab<br>* Subcutaneous injection of Denosumab<br>* Other names: Prolia;|
| No Intervention: No Denosumab<br>No intervention, just observation of HPN patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment tolerance: gastrointestinal | The presence of adverse events from gastrointestinal tract: nausea, vomiting, diarhhoea | 36 months | 
| Treatment tolerance: bone pain | The presence of bone pain assessed with VAS score | 36 months |