Idiopathic Parkinson's DiseaseDOPPANCT03095690
Volumetric Bone Mineral Density and it's Relationship With Osteoporotic Fractures in Parkinson's Disease
A study testing High resolution peripheral scanner (HRpQCT). in people with Idiopathic Parkinson's Disease, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Idiopathic Parkinson's disease (IPD) is the second most frequent neurodegenerative disease. Its association with osteroporosis and fragility fracture is now clearly demonstrated, but the determinants of this osteoporosis are yet to be explained. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- High resolution peripheral scanner (HRpQCT).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2016to 21 Jun 2017
- Phase
- Interventional
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with idiopathic Parkinson's disease according to the criteria of the UKPDBB.
- Parkinson's disease of moderate severity (Index HOEHN and Yahr <5)
- Patient can respond to questionnaires, with or without help
Who cannot join
- Patients with active psychiatric illness preventing the realization of examinations
- Severe Parkinson's disease (Index HOEHN and Yahr ≥5 )
- Heavy-morbidity including heart failure NYHA> 3 or chronic respiratory failure, terminal or severe renal impairment known dialyzed
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Volumetric Bone Mineral Density at the Tibia and Radius and it's Relationship With Osteoporotic Fractures in Idiopathic Parkinson's Disease
Idiopathic Parkinson's disease (IPD) is the second most frequent neurodegenerative disease. Its association with osteroporosis and fragility fracture is now clearly demonstrated, but the determinants of this osteoporosis are yet to be explained. Our aim was to study factors associated with volumetric bone mineral density (vBMD) and bone microstructure at the tibia and radius in IPD.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- High resolution peripheral scanner (HRpQCT).
- Keywords
- Osteoporosis, Parkinson, HR-pQCT, bone microstructure, fracture risk
- Medical subject headings
- Parkinson Disease, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution peripheral scanner (HRpQCT).Other
radius and tibia osteodensitometry measurement
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Parkinson's Disease patients | Other | High resolution peripheral scanner (HRpQCT). Receives: Other: High resolution peripheral scanner (HRpQCT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of volumetric bone mineral density at the tibia and radius
Measurement performed by High Resolution peripheral Quantitative Computed Tomography (HRpQCT)
Measured: 0 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start7 Jan 2016
- Primary completionJul 2016
- Study completion21 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric LESPESSAILLES, Ph, Principal investigator, CHR d'ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095690
- Sponsor's protocol ID
- CHRO-2015-05
- Acronym
- DOPPA
- Status last verified
- Mar 2018
- First submitted
- 8 Feb 2017
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Volumetric Bone Mineral Density at the Tibia and Radius and it's Relationship With Osteoporotic Fractures in Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03095690
- Acronym / sponsor ID
- DOPPA / CHRO-2015-05
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Osteoporosis, Parkinson, HR-pQCT, bone microstructure, fracture risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 7 Jan 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 30 Mar 2017 (actual)
- 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.
Idiopathic Parkinson's disease (IPD) is the second most frequent neurodegenerative disease. Its association with osteroporosis and fragility fracture is now clearly demonstrated, but the determinants of this osteoporosis are yet to be explained. Our aim was to study factors associated with volumetric bone mineral density (vBMD) and bone microstructure at the tibia and radius in IPD.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Parkinson's Disease patients | Other | Other: High resolution peripheral scanner (HRpQCT).High resolution peripheral scanner (HRpQCT). |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with idiopathic Parkinson's disease according to the criteria of the UKPDBB.
- Parkinson's disease of moderate severity (Index HOEHN and Yahr <5)
- Patient can respond to questionnaires, with or without help
Key exclusion criteria (4 listed)
- Patients with active psychiatric illness preventing the realization of examinations
- Severe Parkinson's disease (Index HOEHN and Yahr ≥5 )
- Heavy-morbidity including heart failure NYHA> 3 or chronic respiratory failure, terminal or severe renal impairment known dialyzed
- Pregnancy
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 |
|---|---|---|
| High resolution peripheral scanner (HRpQCT).radius and tibia osteodensitometry measurement | Other | Idiopathic Parkinson's Disease patients |
Primary outcome
Measurement of volumetric bone mineral density at the tibia and radius
Time frame: 0 hour
Measurement performed by High Resolution peripheral Quantitative Computed Tomography (HRpQCT)
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 13 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Eric LESPESSAILLES, Ph principal investigator
CHR d'ORLEANS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High resolution peripheral scanner (HRpQCT). in people with Idiopathic Parkinson's Disease, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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 3 inclusion and 4 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 13 Mar 2018. 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 France. 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.
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?
Measurement of volumetric bone mineral density at the tibia and radius (time frame: 0 hour). 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 13 Mar 2018.