Parkinson's DiseasePAFOSNCT02930512
Study of Factors Associated With the Volumetric and Areal Bone Mineral Density and Bone Strength in Parkinson's Disease
An observational study of Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Studies show that patients with idiopathic Parkinson's disease (IPD) have an increased risk of fracture, particularly hip fracture whose complications and postoperative mortality appear to be higher than in the general population. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- DXA scan and pQCT scan
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2016to Jul 2022
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with idiopathic Parkinson's disease
Who may be able to join
- Idiopathic parkinson's disease (UKPDSBB criteria)
- Hoen and Yahr score < 4 (ON periods)
- Age between 35 and 70 years old
- Independent person at home
Who cannot join
- Dementia patient and progressive mental illness
- Patient with severe tremor
- Incapacity to walk over ten minutes
- Treatment influencing bone metabolism
- Disease influencing phosphocalcic metabolism
- Severe comorbidities
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Sandrine MALOCHET
About this study
Studies show that patients with idiopathic Parkinson's disease (IPD) have an increased risk of fracture, particularly hip fracture whose complications and postoperative mortality appear to be higher than in the general population.
This increased risk of fracture is due partly to an increased risk of falling, and secondly to an impairment of bone tissue with lower bone mineral density (BMD). A meta-analysis concluded that patients with IPD have lower BMD than healthy controls. Prospective studies also showed rapid bone loss in these patients compared with controls. The association between low BMD and IPD seems dependent on the severity and duration of the disease even if some data are contradictory. Various mechanisms may explain this bone loss including weight loss, malnutrition and a low level of physical activity. However, enrollments in these studies are often weak and it is difficult to conclude on the real impact of these factors on bone loss in the IPD. The main objective of our study is to assess and prioritize from these various bone loss mechanisms. Bone assessment by "peripheral quantitative computed tomography" (pQCT) will also assess the impact of various risk factors on bone strength parameters. The prevalence of vertebral compression fractures in the IPD, at this day unknown can be evaluated. This study will also estimate the prevalence of vertebral compression fractures in the IPD.
Read the detailed description
Studies show that patients with idiopathic Parkinson's disease (IPD) have an increased risk of fracture, particularly hip fracture whose complications and postoperative mortality appear to be higher than in the general population.
This increased risk of fracture is due partly to an increased risk of falling, and secondly to an impairment of bone tissue with lower bone mineral density (BMD). A meta-analysis concluded that patients with IPD have lower BMD than healthy controls. Prospective studies also showed rapid bone loss in these patients compared with controls. The association between low BMD and IPD seems dependent on the severity and duration of the disease even if some data are contradictory. Various mechanisms may explain this bone loss including weight loss, malnutrition and a low level of physical activity. However, enrollments in these studies are often weak and it is difficult to conclude on the real impact of these factors on bone loss in the IPD. The main objective of our study is to assess and prioritize from these various bone loss mechanisms. Bone assessment by "peripheral quantitative computed tomography" (pQCT) will also assess the impact of various risk factors on bone strength parameters. The prevalence of vertebral compression fractures in the IPD, at this day unknown can be evaluated. This study will also estimate the prevalence of vertebral compression fractures in the IPD.
- Conditions
- Parkinson's Disease
- Being tested
- DXA scan, pQCT scan
- Keywords
- Bone mineral density, Osteoporosis, Parkinson's disease, Bone turnover markers
- 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.
DXA scanProcedure or surgery
pQCT scanProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| patients with idiopathic Parkinson's disease | Not described Receives: Procedure: DXA scan; Procedure: pQCT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total bone mineral density of the tibia and radius quantified by peripheral quantitative computed tomography (pQCT)
Measured: at day 1
Secondary outcomes (9)
Trabecular and cortical bone mineral density of the tibia and the radius
Measured: at day 1
Architectural parameters and bone resistance of the tibia and radius measured by pQCT
Measured: at day 1
Axial muscular area of the tibia and radius measured by pQCT
Measured: at day 1
Bone mineral density of the lumbar spine and hip measured by DXA
Measured: at day 1
body composition by DXA
Measured: at day 1
Parkinson's disease score
Measured: at day 1
Bone turnovers markers (CTX), 25 OH vitamin D
Measured: at day 1
Vertebral fracture assessment (VFA)
Measured: at day 1
Trabecular bone score of the lumbar spine
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study start21 Jun 2016
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine MALOCHET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930512
- Sponsor's protocol ID
- CHU-0281
- Other IDs
- 2016-A00458-43
- Acronym
- PAFOS
- Status last verified
- Feb 2021
- First submitted
- 7 Oct 2016
- Last updated
- 16 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Factors Associated With the Volumetric and Areal Bone Mineral Density and Bone Strength in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02930512
- Acronym / sponsor ID
- PAFOS / CHU-0281
- Conditions
- Parkinson's Disease
- Keywords
- Bone mineral density, Osteoporosis, Parkinson's disease, Bone turnover markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 12 Oct 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.
Studies show that patients with idiopathic Parkinson's disease (IPD) have an increased risk of fracture, particularly hip fracture whose complications and postoperative mortality appear to be higher than in the general population.
This increased risk of fracture is due partly to an increased risk of falling, and secondly to an impairment of bone tissue with lower bone mineral density (BMD). A meta-analysis concluded that patients with IPD have lower BMD than healthy controls. Prospective studies also showed rapid bone loss in these patients compared with controls. The association between low BMD and IPD seems dependent on the severity and duration of the disease even if some data are contradictory. Various mechanisms may explain this bone loss including weight loss, malnutrition and a low level of physical activity. However, enrollments in these studies are often weak and it is difficult to conclude on the real impact of these factors on bone loss in the IPD. The main objective of our study is to assess and prioritize from these various bone loss mechanisms. Bone assessment by "peripheral quantitative computed tomography" (pQCT) will also assess the impact of various risk factors on bone strength parameters. The prevalence of vertebral compression fractures in the IPD, at this day unknown can be evaluated. This study will also estimate the prevalence of vertebral compression fractures in the IPD.
Detailed description
Studies show that patients with idiopathic Parkinson's disease (IPD) have an increased risk of fracture, particularly hip fracture whose complications and postoperative mortality appear to be higher than in the general population.
This increased risk of fracture is due partly to an increased risk of falling, and secondly to an impairment of bone tissue with lower bone mineral density (BMD). A meta-analysis concluded that patients with IPD have lower BMD than healthy controls. Prospective studies also showed rapid bone loss in these patients compared with controls. The association between low BMD and IPD seems dependent on the severity and duration of the disease even if some data are contradictory. Various mechanisms may explain this bone loss including weight loss, malnutrition and a low level of physical activity. However, enrollments in these studies are often weak and it is difficult to conclude on the real impact of these factors on bone loss in the IPD. The main objective of our study is to assess and prioritize from these various bone loss mechanisms. Bone assessment by "peripheral quantitative computed tomography" (pQCT) will also assess the impact of various risk factors on bone strength parameters. The prevalence of vertebral compression fractures in the IPD, at this day unknown can be evaluated. This study will also estimate the prevalence of vertebral compression fractures in the IPD.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with idiopathic Parkinson's disease | – | Procedure: DXA scan, Procedure: pQCT scan |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with idiopathic Parkinson's disease
Key inclusion criteria (4 listed)
- Idiopathic parkinson's disease (UKPDSBB criteria)
- Hoen and Yahr score < 4 (ON periods)
- Age between 35 and 70 years old
- Independent person at home
Key exclusion criteria (7 listed)
- Dementia patient and progressive mental illness
- Patient with severe tremor
- Incapacity to walk over ten minutes
- Treatment influencing bone metabolism
- Disease influencing phosphocalcic metabolism
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 |
|---|---|---|
| DXA scan | Procedure or surgery | patients with idiopathic Parkinson's disease |
| pQCT scan | Procedure or surgery | patients with idiopathic Parkinson's disease |
Primary outcome
Total bone mineral density of the tibia and radius quantified by peripheral quantitative computed tomography (pQCT)
Time frame: at day 1
9 secondary outcomes
Trabecular and cortical bone mineral density of the tibia and the radius
Time frame: at day 1
Architectural parameters and bone resistance of the tibia and radius measured by pQCT
Time frame: at day 1
Axial muscular area of the tibia and radius measured by pQCT
Time frame: at day 1
Bone mineral density of the lumbar spine and hip measured by DXA
Time frame: at day 1
body composition by DXA
Time frame: at day 1
Parkinson's disease score
Time frame: at day 1
Bone turnovers markers (CTX), 25 OH vitamin D
Time frame: at day 1
Vertebral fracture assessment (VFA)
Time frame: at day 1
Trabecular bone score of the lumbar spine
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
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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.
Sandrine MALOCHET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total bone mineral density of the tibia and radius quantified by peripheral quantitative computed tomography (pQCT) (time frame: at day 1). 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 16 Feb 2021.