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

July 29, 2016 updated by: Stanislaw Klek, Stanley Dudrick's Memorial Hospital

Denosumab Counteracts Metabolic Bone Disease in Chronic Intestinal Failure Patients: A Randomized, Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Skawina, Poland, 32-050
        • Stanley Dudrick's Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • intestinal failure requiring home parental nutrition
  • bone disease measurement

Exclusion Criteria:

  • intestinal failure not requiring HPN
  • diagnostic modalities impossible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 months
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
36 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanley Dudrick's Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Denozumab

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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