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

February 15, 2021 updated by: University Hospital, Clermont-Ferrand

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand
        • Principal Investigator:
          • Sandrine MALOCHET

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with idiopathic Parkinson's disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with idiopathic Parkinson's disease
Procedure: DXA scan
Procedure: pQCT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total bone mineral density of the tibia and radius quantified by peripheral quantitative computed tomography (pQCT)
Time Frame: at day 1
at day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Sandrine MALOCHET, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 21, 2016

Primary Completion (ANTICIPATED)

July 1, 2022

Study Completion (ANTICIPATED)

July 1, 2022

Study Registration Dates

First Submitted

October 7, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (ESTIMATE)

October 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0281
  • 2016-A00458-43 (OTHER: 2016-A00458-43)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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