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Completed

NCT Number: NCT02853539

Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients

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.

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Key information

Conditions

Metabolic Bone Disease Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • intestinal failure requiring home parental nutrition
  • bone disease measurement

Exclusion criteria

  • intestinal failure not requiring HPN
  • diagnostic modalities impossible

Treatment and study plan

Denosumab

Drug

Subcutaneous injection of Denosumab

Other names: Prolia

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Treatment tolerance: gastrointestinal

    Time frame: 36 months

    The presence of adverse events from gastrointestinal tract: nausea, vomiting, diarhhoea

  2. Treatment tolerance: bone pain

    Time frame: 36 months

    The presence of bone pain assessed with VAS score

Sponsors and collaborators

Lead sponsor

Stanley Dudrick's Memorial Hospital

Other

Registry information

Official study title

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

Acronym: Denoz

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 3, 2016
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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