Status:
COMPLETED
The Effects of Vitamin D and Bone Loss in Parkinson's Disease
Lead Sponsor:
Memorial Medical Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Health care burdens from neurodegenerative diseases are expected to increase disproportionately. Increasing age also predisposes this same population to other chronic diseases including osteoporosis, ...
Detailed Description
Parkinson's disease is the second most common neurodegenerative disorder after Alzheimer's disease affecting approximately 1% of the population older than 50 years. There is a worldwide increase in di...
Eligibility Criteria
Inclusion
- Subject must be \>18 yrs of age
- Subject must have a diagnosis of Parkinson's disease (Hoehn and Yahr stages I-III), confirmed by the study physician designated to complete patient staging
- Subject must sign the informed consent documentation according to MMC's IRB guidelines
- Subject must be willing and able to complete all study requirements at the designated time intervals
- Subject must agree to be randomized
- If subject has been taking a separate Vitamin D supplement other than a multivitamin within the last 6 months, the subject must be willing to discontinue Vitamin D supplement for 3 months before entering the study
- Subject must have a vitamin D level greater than 10 ng/mL
- Subjects must have a serum calcium level within the range of 8.4-10 mg/dl.
- Females subjects of child bearing potential must have a negative urine pregnancy test or have undergone a sterilization procedure
Exclusion
- Subjects \< 18 years old
- Parkinson's disease patients with Hoehn and Yahr stages IV-V.
- Subjects not willing and able to complete all study requirements at the designated time intervals
- Subjects who do not agree to be randomized
- Subjects receiving treatment with bisphosphonates (more that 3 months), parathyroid hormones (PTH) or PTH derivatives, e.g. Teriparatide or Fluoride, in the last 6 months.
- Subjects with an allergy to the investigational product.
- Subjects who have a vitamin D level less than 10 ng/mL
- Subjects who do not have a serum calcium level within the range of 8.4-10 mg/dl.
- Subjects who are pregnant, verified by a urine pregnancy test\*
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00907972
Start Date
September 1 2009
End Date
January 1 2013
Last Update
July 12 2013
Active Locations (1)
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1
Conemaugh Health System - John P Murtha Neuroscience and Pain Institute
Johnstown, Pennsylvania, United States, 15904