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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03806517
• Other study ID #: Ordu University 1
• Status: Not yet recruiting
• Start date: February 10, 2019
• Est. completion date: February 28, 2019

Study information

• Verified date: February 2019
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: Sevim ACARÖZ CANDAN, PhD
• Phone: 00905071027447
• Email: fzt_acaroz[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: February 28, 2019
• Est. primary completion date: February 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Loss
• Parkinson Disease

Locations

Country	Name	City	State
Turkey	Sevim ACARÖZ CANDAN	Ordu	Altinordu

Sponsors (1)

Lead Sponsor	Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dual-energy X-ray absorptiometry (DEXA)	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	Hoehn and Yahr Scale	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
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS) - Section of Activities of Daily Living (ADL)	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
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Section	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
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS) - non-motor Section	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
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS) - complications Section	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