Metabolic Bone DiseasePhase 4DenozNCT02853539
Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients
A Phase 4 study testing Denosumab in people with Metabolic Bone Disease, run by Stanley Dudrick's Memorial Hospital at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Bone Disease
- What is being tested?
- Denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2011to Jul 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- intestinal failure requiring home parental nutrition
- bone disease measurement
Who cannot join
- intestinal failure not requiring HPN
- diagnostic modalities impossible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Denosumab Counteracts Metabolic Bone Disease in Chronic Intestinal Failure Patients: A Randomized, Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Metabolic Bone Disease
- Being tested
- Denosumab
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Also called Prolia
Subcutaneous injection of Denosumab
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Experimental | One per 6 months subcutaneous injection of Denosumab (2 doses in total) Receives: Drug: Denosumab |
| No Denosumab | No intervention | No intervention, just observation of HPN patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 36 months
Secondary outcomes (2)
Treatment tolerance: gastrointestinal
The presence of adverse events from gastrointestinal tract: nausea, vomiting, diarhhoea
Measured: 36 months
Treatment tolerance: bone pain
The presence of bone pain assessed with VAS score
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJan 2011
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Bone DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanley Dudrick's Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanislaw Klek, Stanley Dudrick's Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853539
- Sponsor's protocol ID
- Denozumab
- Acronym
- Denoz
- Status last verified
- Jul 2016
- First submitted
- 19 Jul 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denosumab Counteracts Metabolic Bone Disease in Chronic Intestinal Failure Patients: A Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02853539
- Acronym / sponsor ID
- Denoz / Denozumab
- Conditions
- Metabolic Bone Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Stanley Dudrick's Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Experimental | Drug: DenosumabOne per 6 months subcutaneous injection of Denosumab (2 doses in total) |
| No Denosumab | No intervention | –No intervention, just observation of HPN patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- intestinal failure requiring home parental nutrition
- bone disease measurement
Key exclusion criteria (2 listed)
- intestinal failure not requiring HPN
- diagnostic modalities impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DenosumabAlso: ProliaSubcutaneous injection of Denosumab | Drug | Denosumab |
Primary outcome
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
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
2 secondary outcomes
Treatment tolerance: gastrointestinal
Time frame: 36 months
Treatment tolerance: bone pain
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosumab in people with Metabolic Bone Disease, run by Stanley Dudrick's Memorial Hospital at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of bone structure: Spine (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.