NCT02853539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
Last Updated

August 3, 2016

Status Verified

July 1, 2016

Enrollment Period

5.5 years

First QC Date

July 19, 2016

Last Update Submit

July 29, 2016

Conditions

Metabolic Bone Disease

Outcome Measures

Primary Outcomes (2)

  • 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

    36 months

  • 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

    36 months

Secondary Outcomes (2)

  • Treatment tolerance: gastrointestinal

    36 months

  • Treatment tolerance: bone pain

    36 months

Study Arms (2)

Denosumab

EXPERIMENTAL

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

Drug: Denosumab

No Denosumab

NO INTERVENTION

No intervention, just observation of HPN patients

Interventions

DenosumabDRUG

Subcutaneous injection of Denosumab

Also known as: Prolia
Denosumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • intestinal failure requiring home parental nutrition
  • bone disease measurement

You may not qualify if:

  • intestinal failure not requiring HPN
  • diagnostic modalities impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department

Study Record Dates

First Submitted

July 19, 2016

First Posted

August 3, 2016

Study Start

January 1, 2011

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 3, 2016

Record last verified: 2016-07

Locations

PL(1)