Clinical trial NCT02930512: Study of Factors Associated With the Volumetric and Areal Bone Mineral Density and Bone Strength in Parkinson's Disease
Official title: Study of Factors Associated With the Volumetric and Areal Bone Mineral Density and Bone Strength in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Keywords: Bone mineral density
Osteoporosis
Parkinson's disease
Bone turnover markers
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic Parkinson's disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total bone mineral density of the tibia and radius quantified by peripheral quantitative computed tomography (pQCT)
timeFrame: at day 1
Secondary outcomes:
measure: Trabecular and cortical bone mineral density of the tibia and the radius
timeFrame: at day 1
measure: Architectural parameters and bone resistance of the tibia and radius measured by pQCT
timeFrame: at day 1
measure: Axial muscular area of the tibia and radius measured by pQCT
timeFrame: at day 1
measure: Bone mineral density of the lumbar spine and hip measured by DXA
timeFrame: at day 1
measure: body composition by DXA
timeFrame: at day 1
measure: Parkinson's disease score
timeFrame: at day 1
measure: Bone turnovers markers (CTX), 25 OH vitamin D
timeFrame: at day 1
measure: Vertebral fracture assessment (VFA)
timeFrame: at day 1
measure: Trabecular bone score of the lumbar spine
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sandrine MALOCHET
role: PRINCIPAL_INVESTIGATOR
References: