Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients

NCT ID: NCT02853539

Last Updated: 2016-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Metabolic Bone Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Denosumab

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

Group Type EXPERIMENTAL

Denosumab

Intervention Type DRUG

Subcutaneous injection of Denosumab

No Denosumab

No intervention, just observation of HPN patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Denosumab

Subcutaneous injection of Denosumab

Intervention Type DRUG

Other Intervention Names

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Prolia

Eligibility Criteria

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Inclusion Criteria

* intestinal failure requiring home parental nutrition
* bone disease measurement

Exclusion Criteria

* intestinal failure not requiring HPN
* diagnostic modalities impossible
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanley Dudrick's Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stanislaw Klek

Head of the Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanley Dudrick's Memorial Hospital

Skawina, , Poland

Site Status

Countries

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Poland

Other Identifiers

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Denozumab

Identifier Type: -

Identifier Source: org_study_id

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