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

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Parkinson's Disease

Treatments: Procedure: DXA scan; Procedure: pQCT scan

Study type: Observational

Funder types: Other

Identifiers

NCT02930512

CHU-0281

2016-A00458-43 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

patients with idiopathic Parkinson's disease

Treatment:

Procedure: pQCT scan

Procedure: DXA scan