Primary Hyperparathyroidism: Neurocognitive Features

Lead Investigator: Marcella Walker, MD

Coordinator: Diane Cozadd

Contact: 212-342-5231

Email: dkc2121@cumc.columbia.edu

Section: Metabolic Bone Disease Unit (Endocrinology)

Funding: NIH/NIDDK; Columbia Aging Center Grant; Irving Institute Imaging Pilot Award

Description:

Primary hyperparathyroidism (PHPT) is a common condition caused by over-activity of the parathyroid gland(s), which leads to elevated parathyroid hormone and blood calcium levels. Many PHPT patients report nonspecific problems with thinking and memory. However, the mechanism of cognitive changes in PHPT is not clear. Additionally, there are insufficient data to determine if surgical correction of PHPT with parathyroidectomy (PTX) reverses the changes in cognition present in PHPT. Therefore, further studies are needed to guide the management of PHPT patients with cognitive symptoms. Our preliminary data shows that functional magnetic resonance imaging (fMRI) can detect changes in brain activation in patients with PHPT, which are reversible with PTX. Other studies have also shown that ultrasound of the blood vessels of the brain using transcranial Doppler (TCD) can detect abnormalities in blood flow in other disorders of thinking and memory. We hypothesize that parathyroid hormone increases stiffness of the blood vessels that supply the brain and that is reduction in blood flow affects cognition. This study will investigate changes in cognitive function, brain blood flow by TCD, and fMRI brain activity in PHPT patients before and after PTX in comparison with three other groups: patients with PHPT who are not having surgery, patients with normo-calcemic PHPT (normal calcium, high PTH), and patients having thyroid surgery. We aim to demonstrate that PHPT patients have abnormal fMRI brain activity and brain blood flow compared to control subjects and that the abnormalities are reversed after PTX. Results from this study will contribute towards development of surgical guidelines for the management of PHPT patients with cognitive symptoms. If you would like to participate or are interested in learning more about the study, please contact our study coordinator.

Link: https://projectreporter.nih.gov/project_info_description.cfm?aid=8967918&icde=26536370&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC

Occult Nephrolithiasis in Primary Hyperparathyroidism

Lead Investigator: Marcella Walker, MD

Coordinator: Diane Cozadd

Contact: 212-342-5231

Email: dkc2121@cumc.columbia.edu

Section: Metabolic Bone Disease Unit (Endocrinology)

Funding: NIH/NIDDK; Columbia Aging Center Grant; Irving Institute Imaging Pilot Award

Description:

Primary hyperparathyroidism (PHPT) is a relatively common endocrine disorder in which the parathyroid glands become overactive leading to high blood calcium and parathyroid hormone levels. Today, most patients with PHPT are asymptomatic and are diagnosed based on mild hypercalcemia noted on routine lab work. Symptomatic kidney stones (nephrolithiasis) affect about 15-20% of patients with PHPT and such patients are advised to have parathyroidectomy (PTX). The most recent set of guidelines regarding the management of asymptomatic PHPT (2013) recommend renal imaging for all patients with asymptomatic PHPT to screen for occult kidney stones. PTX is advised for patients found to have occult nephrolithiasis. There is limited data on the prevalence of asymptomatic nephrolithiasis in patients with PHPT. This study will determine the prevalence of occult nephrolithiasis through a prospective chart review and will also clarify what disease features are associated with this finding. The study will enroll patients who are being sent for renal imaging (ultrasound, xray, CT or MRI etc.) as part of their clinical evaluation or follow up for PHPT by their doctor as well as those who have had recent renal imaging. After obtaining informed consent (permission) from the patient, data from the patient’s chart/medical record will be collected, if available, including historical items such as age, gender, fracture history, whether or not any surgical criteria for PTX have been met; laboratory data including urinary calcium testing, 25-hydroxyvitamin D levels, 1,25-dihydroxyvitamin D levels, phosphorus, creatinine, serum and ionized calcium, albumin, and parathyroid hormone levels; radiology results from renal imaging; spine imaging (for presence of occult vertebral fractures); and DXA results. All of these tests are typically ordered by primary physicians as part of the routine care for primary hyperparathyroidism. No additional testing will be done for missing data and no additional visits are required by participants. If you are interested in participating or finding out more about this study, please contact the study coordinator.

Genetics of Plate- or Rod-like Bone Phenotype

Lead Investigator: Marcella Walker, MD

Coordinator: Wendy Fan

Contact: 212-305-7364

Email: wf2159@cumc.columbia.edu

Section: Metabolic Bone Disease Unit (Endocrinology)

Compensation: $80

Description:

Asian men and women have lower bone mineral density and yet have fewer hip and forearm fractures versus Caucasians. Recent advances in technology now allow us to see the bone’s internal microscopic structure, including the thick outer shell of the bone called cortex, and inner bone network composed of interconnecting bone plates and rods called trabecular bone. In a prior study, we found that the inner bone of Chinese women was composed of many more plates than rods compared to white women. This characteristic led to stronger bones compared to white women. The most striking difference between the races was the number of plates versus rods or a parameter called the tibial trabecular plate-rod ratio (TPR). We used this ratio to characterize each woman’s inner bone as more “plate-like” or “rod-like”. Women in the top 25% of the TPR trait have plate-like bone whereas women in the lowest 25% have rod-like bone. In our prior study, we found that women who had values in the top 25% of this TPR trait were much more likely to be Chinese- American than women with rod-like bone in the lowest quartile. The purpose of this study is to identify the genetic factors (genes) that cause a person’s trabecular bone to be more plate- versus rod-like. Results of this study can help increase understanding of the genetic basis for the observed differences in bone structure and strength between different races.

Cystic fibrosis related bone disease

Recent advances have improved the management of cystic fibrosis and increased the life expectancy for patients. However, there has been an increase in other medical complications such as bone disease. There are a higher number of fractures in people with cystic fibrosis compared to those without the disease; however, it is not clear how bone density and structure is changed by the disease.

We are recruiting women and men with and without cystic fibrosis.

You may be eligible if you are:

• Between the ages of 18 and 50 years old
• Interested in learning about your bone health
• With or without cystic fibrosis

You are not eligible if you:

• Have cancer
• Are pregnant
• Have a parathyroid disorder

A study visit involves:

• A visit to Columbia University Medical Center for about 2 hrs
• A bone health evaluation including imaging and blood tests

You will receive $25 to compensate for travel costs.

For more information please call 212-342-5725 or email Anna at: alk2186@cumc.columbia.edu

Download the full study brochure here.

Treatment of Vitamin D Deficiency in patients with PHPT

Many patients with mild Primary Hyperparathyroidism (PHPT) have Vitamin D deficiency. Both PHPT and Vitamin D deficiency can weaken bones and cause osteoporosis. Recent medical guidelines recommend treating patients with PHPT and low vitamin D levels with Vitamin D. Treatment with Vitamin D is particularly important in PHPT patients undergoing surgery to prevent postsurgical complications such as a low blood calcium. This study is designed to investigate the impact of two different Vitamin D repletion regimens over a 6 month period in patients with PHPT and low vitamin D.

We are recruiting women and men with PHPT.

You may be eligible if you have:

• Primary Hyperparathyroidism
• Low Vitamin D levels

You may not eligible if you have a history of:

• Kidney or Liver disease
• Long-term use of steroid medications, some anti-seizure medications or current use of Cinacalcet
• Organ transplantation
• GI diseases such as Crohn’s or Celiac Disease
• Malignancy (other than cured basal or squamous cell skin carcinoma) within the last 5 years
• Sarcoidosis
• HIV/AIDS

This is a randomized controlled trial which means that you will either:

1. Receive active Vitamin D treatment at baseline (80% of participants) + a daily multivitamin with Vitamin D or:
2. Receive a placebo at baseline (20% of participants) + a daily multivitamin with Vitamin D

Group 1 or 2 assignment is by chance (randomized). Neither you nor your physician will know which group you are in until the 6 month time point.

This study involves:

• Four visits to Columbia University Medical Center over 6 months
• A bone health evaluation at no cost to you including bone density imaging, blood and urine tests at the baseline and 6 month study visits

You will receive $75 for completing each study visit—a total of $300 for completing all four study visits. After the 6 month study visit you will receive a copy of all study results.

For more information please call 212-342-5725 or email Anna at: alk2186@cumc.columbia.edu

Download the full study brochure here.

Time-Restricted Eating to Improve Cardiometabolic Health (NY-TREAT Study)

The New York-TREAT study is a randomized trial that will examine the effect of self-monitoring food intake via a smart phone application, and of a novel lifestyle intervention called time restricted eating, on improvement of metabolic health in persons with overweight or obesity and with prediabetes or type 2 diabetes. The intervention lasts 12 months and will be administered via a smartphone app. Participants will use the app to take pictures of all food and drinks, every day for 3 months, then 10 days a month for the following 9 months. Participation requires one screening visit (~1hr), and seven outpatient visits (~1-5hr) including an IV catheter in your arm for blood samples. In addition to potential health benefits, you will get your body fat and energy expenditure measured and you can receive up to $2000 total compensation.

We are recruiting 50-75 year old adults with overweight or obesity, type 2 Diabetes or Prediabetes.

You may be eligible if you have:

• BMI between 25 and 46 kg/m2
• A smartphone
• Can read and speak English

You may not be eligible if you:

• Are engaging in a current weight loss program or diet
• Take medication for weight loss or for diabetes, with the exception of metformin
• Have a history of heart failure/kidney failure/liver failure/ and/or lung disease
• Work night shifts

See if you may be eligible:

https://cumc.co1.qualtrics.com/jfe/form/SV_5ztwcztAVs4CT9Y

This is a randomized trial which means you will either:

• Continue to eat and drink in your habitual hours OR
• Reduce the number of hours you eat to a set window of time

Study involves:

• Participation over the course of 12 months
• Measurement of body fat and energy expenditure
• Eight visits to Columbia University Research Center
• You may receive up to $2000 for your participation in the study

For more information:

If you are interested to hear more and find out whether you qualify, please contact the study team via email at  nytreatstudy@gmail.com or call either 212-851-5581 or 212-851-5318. A team member will follow up with you by phone within two weeks. 1 or 2 assignment is by chance (randomized).

Download the full study brochure here.