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

Primary Purpose

Metabolic Bone Disease

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Denosumab
Sponsored by
Stanley Dudrick's Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Bone Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • intestinal failure requiring home parental nutrition
  • bone disease measurement

Exclusion Criteria:

  • intestinal failure not requiring HPN
  • diagnostic modalities impossible

Sites / Locations

  • Stanley Dudrick's Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Denosumab

No Denosumab

Arm Description

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

No intervention, just observation of HPN patients

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2016
Last Updated
July 29, 2016
Sponsor
Stanley Dudrick's Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02853539
Brief Title
Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients
Acronym
Denoz
Official Title
Denosumab Counteracts Metabolic Bone Disease in Chronic Intestinal Failure Patients: A Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanley Dudrick's Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Bone Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Denosumab
Arm Type
Experimental
Arm Description
One per 6 months subcutaneous injection of Denosumab (2 doses in total)
Arm Title
No Denosumab
Arm Type
No Intervention
Arm Description
No intervention, just observation of HPN patients
Intervention Type
Drug
Intervention Name(s)
Denosumab
Other Intervention Name(s)
Prolia
Intervention Description
Subcutaneous injection of Denosumab
Primary Outcome Measure Information:
Title
Improvement of bone structure: Spine
Description
The increase of spine bone density measured by the change of Standard Deviation (SD) measured by DEXA at the level L1-L4
Time Frame
36 months
Title
Improvement of bone structure: Femur
Description
The increase of femur bone density measured by the change of Standard Deviation (SD) measured by DEXA at femur trochanter and shaft
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Treatment tolerance: gastrointestinal
Description
The presence of adverse events from gastrointestinal tract: nausea, vomiting, diarhhoea
Time Frame
36 months
Title
Treatment tolerance: bone pain
Description
The presence of bone pain assessed with VAS score
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: intestinal failure requiring home parental nutrition bone disease measurement Exclusion Criteria: intestinal failure not requiring HPN diagnostic modalities impossible
Facility Information:
Facility Name
Stanley Dudrick's Memorial Hospital
City
Skawina
ZIP/Postal Code
32-050
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients

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