Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients

Phase 4

Completed

• Conditions: Metabolic Bone Disease
• Interventions: Drug: Denosumab

• Registration Number: NCT02853539
• Lead Sponsor: Stanley Dudrick's Memorial Hospital

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 Timeline

• Study Start: 2011-01
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-29
• Last Update Submitted: 2016-07-29
• Study First Posted: 2016-08-03
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• intestinal failure requiring home parental nutrition
• bone disease measurement

Exclusion Criteria

• intestinal failure not requiring HPN
• diagnostic modalities impossible

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab	Denosumab	One per 6 months subcutaneous injection of Denosumab (2 doses in total)

Primary Outcome Measures

Name	Time	Method
Improvement of bone structure: Spine	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	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 Outcome Measures

Name	Time	Method
Treatment tolerance: bone pain	36 months	The presence of bone pain assessed with VAS score
Treatment tolerance: gastrointestinal	36 months	The presence of adverse events from gastrointestinal tract: nausea, vomiting, diarhhoea

Trial Locations

Locations (1)

Stanley Dudrick's Memorial Hospital; 🇵🇱 Skawina, Poland