Bone Mineral Density Changes Among Clinical Subtypes of Parkinson's Disease

February 9, 2019 updated by: Sevim ACARÖZ CANDAN, T.C. ORDU ÜNİVERSİTESİ

Bone Mineral Density in Tremor Dominant Type Compared to Postural Instability Gait Difficulty Type Parkinson's Disease: a Cross-sectional Study

The bone loss in Parkinson's disease (PD) emerges as a non-motor symptom with motor and non-motor outcomes, such as fracture and musculoskeletal pain. Bone mineral density (BMD) is decreasing in patients with PD when compared to sex and age-matched healthy controls. The changes in BMD according to clinical subtypes of PD is unknown. The investigators are planning to compare the BMD status between the tremor dominant and postural instability and gait difficulty type of PD.

Study Overview

Status

Unknown

Conditions

Detailed Description

The investigators are planning to complete this study between January and February 2019. This study will be performed at Ordu University Education and Research Hospital, Neurology Department.

All patients admitted to the outpatient clinic will be evaluated in terms of inclusion criteria. The control group consisted of people who do not have any orthopedic, neurological or metabolic disorders which may affect the BMD.

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey
    • Altinordu
      • Ordu, Altinordu, Turkey, 52100
        • Sevim ACARÖZ CANDAN

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

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The PD group will be selcted from Neurology Department, Movement Disorders Clinic.

The control group will be selected from community population.

Description

For TDT and PIGDT PD group

Inclusion Criteria:

Clinical diagnosis of idiopathic Parkinson's disease Age of 40-85 years

Exclusion Criteria:

Having additional orthopedic and neurological disorders Having metabolic disease, Having steroid drug use

For Control group

The similar age and sex-matched healthy individuals who have no orthopedic, metabolic and neurological disorders, and steroid use will be included in the study.

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

  • Observational Models: Case-Crossover
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Tremor dominant type group
Tremor dominant type (TDT) group will consist of the patients with tremor premotor symptoms.
PIGD dominant type group
Postural instability and gait difficulty dominant type (PIGDT) group will consist of the patients with axial premotor symptoms.
Healthy control group
Healthy control group will consist of the subjects with same age and sex matched individuals in PD group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dual-energy X-ray absorptiometry (DEXA)
Time Frame: 10-15 minutes

Bone mineral density will be dertermined using DEXA results. The results will be interpreted by WHO (World Health Organization) criteria.

: T-score (T-score) is determined by DEXA method. A T-score value of more than minus means that there is excess bone loss.

  • Obsolete osteoporosis: A T-score of less than -2.5 SD and a history of fracture in a patient.
  • Osteoporosis: T-score below -2.5 SD. (Like -3, -4 ...)
  • Osteopenia: T-score between -1 and -2.5 SD
  • Normal: T-score value better than -1
10-15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hoehn and Yahr Scale
Time Frame: 2 minutes

Disease progression will be assessed with Hoehn and Yahr Scale. The original scale included stages 1 through 5.

Stage 0: No signs of disease.

Stage 1: Unilateral symptoms only.

Stage 2: Bilateral symptoms. No impairment of balance.

Stage 3: Balance impairment. Mild to moderate disease. Physically independent.

Stage 4: Severe disability, but still able to walk or stand unassisted.

Stage 5: Needing a wheelchair or bedridden unless assisted.
2 minutes
Unified Parkinson's Disease Rating Scale (UPDRS) - Section of Activities of Daily Living (ADL)
Time Frame: 10 minutes
The UPDRS- ADL section evaluates the impact of Parkinson disease on ADL according to patient's perspective. The ADL section consists of 13 items for gathering information on the patient's own perception of functional impairment due to PD. Each item scores between 0-4. 0 means normal and 4 means severe impairment. The total score change between 0-52. High scores indicate severe impairment.
10 minutes
Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Section
Time Frame: 10 minutes
Motor section of UPDRS determines the impairment due to the Parkinson's disease. Rigidity, bradykinesia and tremor items which are relating with upper extremity function will be assessed. Each item scores between 0-4. 0 means normal and 4 means severe impairment. The total score change between 0-56.
10 minutes
Unified Parkinson's Disease Rating Scale (UPDRS) - non-motor Section
Time Frame: 5 minutes
Non-motor section of UPDRS evaluates the impact of the non motor symptoms in PD. Each item scores between 0-4. 0 means normal and 4 means severe impairment. Total score changes between 0-52.
5 minutes
Unified Parkinson's Disease Rating Scale (UPDRS) - complications Section
Time Frame: 5 minutes
Complications section of UPDRS evaluates the complications after the levodopa treatment in PD. Each item scores between 0-4. 0 means normal and 4 means severe impairment. Total score changes between 0-24.
5 minutes

Collaborators and Investigators

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

Sponsor

T.C. ORDU ÜNİVERSİTESİ

Investigators

  • Principal Investigator: Sevim ACARÖZ CANDAN, T.C. ORDU ÜNİVERSİTESİ

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 (Anticipated)

February 10, 2019

Primary Completion (Anticipated)

February 25, 2019

Study Completion (Anticipated)

February 28, 2019

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 9, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ordu University 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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