Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients

Metabolic Bone Disease Clinical Trial

— Denoz  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853539
• Other study ID #: Denozumab
• Status: Completed
• Phase: Phase 4
• First received: July 19, 2016
• Last updated: July 29, 2016
• Start date: January 2011
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Stanley Dudrick's Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• intestinal failure requiring home parental nutrition

• bone disease measurement

Exclusion Criteria:

• intestinal failure not requiring HPN

• diagnostic modalities impossible

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Metabolic Bone Disease

Intervention

Drug:
• Denosumab
Subcutaneous injection of Denosumab

Locations

Country	Name	City	State
Poland	Stanley Dudrick's Memorial Hospital	Skawina

Sponsors (1)

Lead Sponsor	Collaborator
Stanley Dudrick's Memorial Hospital

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Treatment tolerance: gastrointestinal	The presence of adverse events from gastrointestinal tract: nausea, vomiting, diarhhoea	36 months	No
Secondary	Treatment tolerance: bone pain	The presence of bone pain assessed with VAS score	36 months	No