Parkinson DiseaseNCT03806517
Bone Mineral Density Changes Among Clinical Subtypes of Parkinson's Disease
An observational study of Parkinson Disease and Bone Loss, run by Ordu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Bone Loss
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2019to 28 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The PD group will be selcted from Neurology Department, Movement Disorders Clinic. The control group will be selected from community population.
Who may be able to join
- Clinical diagnosis of idiopathic Parkinson's disease Age of 40-85 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Bone Loss
- Keywords
- bone mineral density, Parkinson's disease, tremor, postural instability and gait difficulty, akinetic-rigid
- Medical subject headings
- Parkinson Disease, Bone Diseases, Metabolic, Tremor, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10-15 minutes
Secondary outcomes (5)
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.
Measured: 2 minutes
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.
Measured: 10 minutes
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.
Measured: 10 minutes
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.
Measured: 5 minutes
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start10 Feb 2019 (estimated)
- Primary completion25 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim ACARÖZ CANDAN, Ordu University
- Investigators
- Sevim ACARÖZ CANDAN, Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806517
- Sponsor's protocol ID
- Ordu University 1
- Status last verified
- Feb 2019
- First submitted
- 14 Jan 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Density in Tremor Dominant Type Compared to Postural Instability Gait Difficulty Type Parkinson's Disease: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03806517
- Acronym / sponsor ID
- Ordu University 1
- Conditions
- Parkinson Disease, Bone Loss
- Keywords
- bone mineral density, Parkinson's disease, tremor, postural instability and gait difficulty, akinetic-rigid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 10 Feb 2019 (estimated)
- Primary completion
- 25 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The PD group will be selcted from Neurology Department, Movement Disorders Clinic. The control group will be selected from community population.
Key inclusion criteria (1 listed)
- Clinical diagnosis of idiopathic Parkinson's disease Age of 40-85 years
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Hoehn and Yahr Scale
Time frame: 2 minutes
Unified Parkinson's Disease Rating Scale (UPDRS) - Section of Activities of Daily Living (ADL)
Time frame: 10 minutes
Unified Parkinson's Disease Rating Scale (UPDRS) - Motor Section
Time frame: 10 minutes
Unified Parkinson's Disease Rating Scale (UPDRS) - non-motor Section
Time frame: 5 minutes
Unified Parkinson's Disease Rating Scale (UPDRS) - complications Section
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevim ACARÖZ CANDAN principal investigator
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Bone Loss, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sevim ACARÖZ CANDAN, PhD (00905071027447, fzt_acaroz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-energy X-ray absorptiometry (DEXA) (time frame: 10-15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.