Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02853539

Acronym

Denoz

Enrollment

Registered

2016-08-03

Start date

2011-01-31

Completion date

2016-07-31

Last updated

2016-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Bone Disease

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.

Interventions

DRUGDenosumab

Subcutaneous injection of Denosumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* intestinal failure requiring home parental nutrition * bone disease measurement

Exclusion criteria

* intestinal failure not requiring HPN * diagnostic modalities impossible

Design outcomes

Primary

Measure	Time frame	Description
Improvement of bone structure: Spine	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	36 months	The increase of femur bone density measured by the change of Standard Deviation (SD) measured by DEXA at femur trochanter and shaft

Secondary

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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026