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

Conditions
Parkinson Disease
Bone Loss
Registration Number
NCT03806517
Lead Sponsor
T.C. ORDU ÜNİVERSİTESİ
Brief Summary

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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
75
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Dual-energy X-ray absorptiometry (DEXA)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

Secondary Outcome Measures
NameTimeMethod
Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Section10 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.

Unified Parkinson's Disease Rating Scale (UPDRS) - non-motor Section5 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.

Hoehn and Yahr Scale2 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.

Unified Parkinson's Disease Rating Scale (UPDRS) - Section of Activities of Daily Living (ADL)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.

Unified Parkinson's Disease Rating Scale (UPDRS) - complications Section5 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.

Trial Locations

Locations (1)

Sevim ACARÖZ CANDAN

🇹🇷

Ordu, Altinordu, Turkey

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