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Veverimer to decrease net acid excretion and bone resorption in adults with osteopenia

Veverimer to decrease net acid excretion and bone resorption in adults with osteopenia

Veverimer to decrease net acid excretion and bone resorption in adults with osteopenia: a dose-finding randomized controlled trial

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Osteopenia
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All genders
person-wave 50+
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Recruiting now

Overview

Principal Investigator: Lisa Ceglia

As people get older, their bones start to break down faster than they rebuild. People with osteopenia (low bone density) who eat acid-producing diets may have a greater risk of developing osteoporosis (a more advanced reduction in bone mass and strength that leads to fractures). Research suggests that lowering acid levels in the body can help protect bone health with age. Some treatments use alkali (like potassium or sodium bicarbonate) to reduce acid, but they can be hard to take and may cause side effects. An investigational drug called veverimer may offer a safer and easier way to lower acid levels. Veverimer is not absorbed into the bloodstream. It works inside the intestines by binding to acid and removing it through the stool. It’s been tested in people with kidney disease, but not for bone health.

We plan to test veverimer in adults 50 years and older who have osteopenia. We will include participants who have a certain level of acid in their urine, measured by a 24-hour urine test. Participants will be randomly assigned to one of three groups: veverimer 9 grams per day, veverimer 9 grams every other day, or matching placebo (no active study drug) and take the study drug for 8 weeks.

The goals of this study are to: 1) evaluate how much veverimer lowers acid levels in the body (measured in urine); 2) check the safety of veverimer by looking at changes in blood bicarbonate levels; 3) measure how veverimer affects markers of bone breakdown (called serum C-telopeptide); 4) measure how veverimer affects markers of new bone formation (called serum procollagen type I N-terminal propeptide); and 5) measure how veverimer affects changes in physical function. 

The information we learn in this study will help researchers decide what dose of veverimer to use in a larger study. Future studies will look at whether veverimer can help slow bone loss and reduce the risk of fractures in people at risk for osteoporosis.

Contact Us

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Elise Danico / Endocrinology Research

Study details

Inclusion Criteria
  • Osteopenia, women need to be at least 5 years postmenopause
Exclusion Criteria
  • Estrogen or testosterone therapy, chronic diarrheal illness, active cancer
Study Requirements

2 screening visits, 6 study visits, 8-week trial, 6 blood draws, total volume of blood 54 ml over 8 weeks, 4 24-hr urine collections, 1 DXA scan of hip/spine, 2 sets of physical performance battery.

 

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