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Study of Factors Associated With the Volumetric and Areal Bone Mineral Density and Bone Strength in Parkinson's Disease

Study of Factors Associated With the Volumetric and Areal Bone Mineral Density and Bone Strength in Parkinson's Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02930512
Acronym
PAFOS
Enrollment
200
Registered
2016-10-12
Start date
2016-06-21
Completion date
2022-07-31
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Bone mineral density, Osteoporosis, Parkinson's disease, Bone turnover markers

Brief 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. 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.

Interventions

PROCEDUREDXA scan
PROCEDUREpQCT scan

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Idiopathic parkinson's disease (UKPDSBB criteria) * Hoen and Yahr score \< 4 (ON periods) * Age between 35 and 70 years old * Independent person at home

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Total bone mineral density of the tibia and radius quantified by peripheral quantitative computed tomography (pQCT)at day 1

Secondary

MeasureTime frame
Trabecular and cortical bone mineral density of the tibia and the radiusat day 1
Architectural parameters and bone resistance of the tibia and radius measured by pQCTat day 1
Axial muscular area of the tibia and radius measured by pQCTat day 1
Bone mineral density of the lumbar spine and hip measured by DXAat day 1
body composition by DXAat day 1
Parkinson's disease scoreat day 1
Bone turnovers markers (CTX), 25 OH vitamin Dat day 1
Vertebral fracture assessment (VFA)at day 1
Trabecular bone score of the lumbar spineat day 1

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026