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

• Conditions: Parkinson's Disease
• Interventions: Procedure: DXA scan; Procedure: pQCT scan

• Registration Number: NCT02930512
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2016-06-21
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-16
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with idiopathic Parkinson's disease	pQCT scan	-
patients with idiopathic Parkinson's disease	DXA scan	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Trabecular and cortical bone mineral density of the tibia and the radius	at day 1
body composition by DXA	at day 1
Bone turnovers markers (CTX), 25 OH vitamin D	at day 1
Parkinson's disease score	at day 1
Vertebral fracture assessment (VFA)	at day 1
Bone mineral density of the lumbar spine and hip measured by DXA	at day 1
Trabecular bone score of the lumbar spine	at day 1
Architectural parameters and bone resistance of the tibia and radius measured by pQCT	at day 1
Axial muscular area of the tibia and radius measured by pQCT	at day 1

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France