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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 19, 2016
First Posted Date  ICMJE August 3, 2016
Last Update Posted Date August 3, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
  • Treatment tolerance: gastrointestinal [ Time Frame: 36 months ]
    The presence of adverse events from gastrointestinal tract: nausea, vomiting, diarhhoea
  • Treatment tolerance: bone pain [ Time Frame: 36 months ]
    The presence of bone pain assessed with VAS score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients
Official Title  ICMJE Denosumab Counteracts Metabolic Bone Disease in Chronic Intestinal Failure Patients: A Randomized, Controlled Clinical Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Bone Disease
Intervention  ICMJE Drug: Denosumab
Subcutaneous injection of Denosumab
Other Name: Prolia
Study Arms  ICMJE
  • Experimental: Denosumab
    One per 6 months subcutaneous injection of Denosumab (2 doses in total)
    Intervention: Drug: Denosumab
  • No Intervention: No Denosumab
    No intervention, just observation of HPN patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2016)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • intestinal failure requiring home parental nutrition
  • bone disease measurement

Exclusion Criteria:

  • intestinal failure not requiring HPN
  • diagnostic modalities impossible
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02853539
Other Study ID Numbers  ICMJE Denozumab
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Stanislaw Klek, Stanley Dudrick's Memorial Hospital
Study Sponsor  ICMJE Stanley Dudrick's Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stanley Dudrick's Memorial Hospital
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP