NCT02930512

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

6 years

First QC Date

October 7, 2016

Last Update Submit

February 15, 2021

Conditions

Parkinson's Disease

Keywords

Bone mineral densityOsteoporosisParkinson's diseaseBone turnover markers

Outcome Measures

Primary Outcomes (1)

  • Total bone mineral density of the tibia and radius quantified by peripheral quantitative computed tomography (pQCT)

    at day 1

Secondary Outcomes (9)

  • Trabecular and cortical bone mineral density of the tibia and the radius

    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

  • Bone mineral density of the lumbar spine and hip measured by DXA

    at day 1

  • body composition by DXA

    at day 1

  • +4 more secondary outcomes

Study Arms (1)

patients with idiopathic Parkinson's disease

Procedure: DXA scanProcedure: pQCT scan

Interventions

DXA scanPROCEDURE
patients with idiopathic Parkinson's disease
pQCT scanPROCEDURE
patients with idiopathic Parkinson's disease

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with idiopathic Parkinson's disease

You may qualify if:

  • Idiopathic parkinson's disease (UKPDSBB criteria)
  • Hoen and Yahr score \< 4 (ON periods)
  • Age between 35 and 70 years old
  • Independent person at home

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseOsteoporosis

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Sandrine MALOCHET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 12, 2016

Study Start

June 21, 2016

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

FR(1)