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Denoz: Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients

Sponsor
Stanley Dudrick's Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02853539
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
66
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Denosumab Counteracts Metabolic Bone Disease in Chronic Intestinal Failure Patients: A Randomized, Controlled Clinical Trial
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Jul 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Denosumab

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

Drug: Denosumab
Subcutaneous injection of Denosumab
Other Names:
  • Prolia

    		•
    No Intervention: No Denosumab

    No intervention, just observation of HPN patients

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. Treatment tolerance: gastrointestinal [36 months]

      The presence of adverse events from gastrointestinal tract: nausea, vomiting, diarhhoea

    2. Treatment tolerance: bone pain [36 months]

      The presence of bone pain assessed with VAS score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanley Dudrick's Memorial Hospital Skawina Poland 32-050

    Sponsors and Collaborators

    • Stanley Dudrick's Memorial Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanislaw Klek, Head of the Department, Stanley Dudrick's Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT02853539
    Other Study ID Numbers:
    • Denozumab
    First Posted:
    Aug 3, 2016
    Last Update Posted:
    Aug 3, 2016
    Last Verified:
    Jul 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Bone Diseases
    Bone Diseases, Metabolic
    Denosumab

    Study Results

    No Results Posted as of Aug 3, 2016