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Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients (Denoz)

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ClinicalTrials.gov Identifier: NCT02853539
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Stanislaw Klek, 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.

Condition or disease Intervention/treatment Phase
Metabolic Bone Disease Drug: Denosumab 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.


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Study Type : Interventional  (Clinical Trial)
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 : January 2011
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Diseases
Drug Information available for: Denosumab

Arm Intervention/treatment
Experimental: Denosumab
One per 6 months subcutaneous injection of Denosumab (2 doses in total)
Drug: Denosumab
Subcutaneous injection of Denosumab
Other Name: Prolia

No Intervention: No Denosumab
No intervention, just observation of HPN patients



Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Treatment tolerance: gastrointestinal [ Time Frame: 36 months ]
    The presence of adverse events from gastrointestinal tract: nausea, vomiting, diarhhoea

  2. Treatment tolerance: bone pain [ Time Frame: 36 months ]
    The presence of bone pain assessed with VAS score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • intestinal failure requiring home parental nutrition
  • bone disease measurement

Exclusion Criteria:

  • intestinal failure not requiring HPN
  • diagnostic modalities impossible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853539


Locations
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Poland
Stanley Dudrick's Memorial Hospital
Skawina, Poland, 32-050
Sponsors and Collaborators
Stanley Dudrick's Memorial Hospital

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Responsible Party: Stanislaw Klek, Head of the Department, Stanley Dudrick's Memorial Hospital
ClinicalTrials.gov Identifier: NCT02853539     History of Changes
Other Study ID Numbers: Denozumab
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs