The Effects of Vitamin D and Bone Loss in Parkinson's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

Health care burdens from neurodegenerative diseases are expected to increase disproportionately. Increasing age also predisposes this same population to other chronic diseases including osteoporosis, a progressive systemic skeletal disease characterized by low bone mass, which leads to an increase susceptibility to fractures. In the United States, 44 million people are estimated to be at risk for osteoporosis and low bone mass emphasizing the enormity of this public health problem. Parkinson's disease is a progressive neurodegenerative disorder affecting about 1 million people. Evidence indicates that Parkinson's disease patients are at a higher risk for low bone mineral density, which can contribute to increased fractures compared to healthy subjects. In fact, several risk factors of osteoporosis in patients with PD have been identified, including advanced stages of PD, low body mass index, inadequate sunlight exposure and decreased vitamin D levels. Some or all of these factors in conjunction with decreased immobilization that may occur with PD, put patients at increased risks for fractures. Few studies however have examined bone markers in PD patients. Even fewer studies have examined the impact of Vitamin D supplementation on bone metabolism and mineralization in PD patients. Vitamin D is an essential component in bone health, promoting calcium absorption in the gut and maintaining adequate serum calcium and phosphate concentrations, which enable normal mineralization of bone.

Key facts

Study ID

NCT00907972

Run by

Memorial Medical Center

People needed

23

Starts

2009-09-01

Expected to finish

2013-01-01

Last updated by the study team

2013-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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*

Where it is running

• Conemaugh Health System - John P Murtha Neuroscience and Pain Institute — Johnstown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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