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

Parkinson's Disease Clinical Trial

— PAFOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02930512
• Other study ID #: CHU-0281
• Secondary ID: 2016-A00458-43
• Status: Recruiting
• Start date: June 21, 2016
• Est. completion date: July 2022

Study information

• Verified date: February 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Procedure:
• DXA scan

• pQCT scan

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total bone mineral density of the tibia and radius quantified by peripheral quantitative computed tomography (pQCT)		at day 1
Secondary	Trabecular and cortical bone mineral density of the tibia and the radius		at day 1
Secondary	Architectural parameters and bone resistance of the tibia and radius measured by pQCT		at day 1
Secondary	Axial muscular area of the tibia and radius measured by pQCT		at day 1
Secondary	Bone mineral density of the lumbar spine and hip measured by DXA		at day 1
Secondary	body composition by DXA		at day 1
Secondary	Parkinson's disease score		at day 1
Secondary	Bone turnovers markers (CTX), 25 OH vitamin D		at day 1
Secondary	Vertebral fracture assessment (VFA)		at day 1
Secondary	Trabecular bone score of the lumbar spine		at day 1