Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia: a Dose-finding Randomized Controlled Trial
Tufts Medical Center
Summary
The goal of this clinical trial is to learn if veverimer will reduce urinary net acid excretion leading to reduced bone resorption in healthy adults with osteopenia. The main questions it aims to answer are: * How much does each dose of veverimer (vs. placebo) reduce 24-hr urinary net acid excretion. * Describe the safety of veverimer based on changes in serum bicarbonate and potassium. * Assess the changes in bone resorption. * Assess the changes in bone formation. * Explore the effect of veverimer on physical performance. Participants will: * Take veverimer or placebo every day or every other day for 8 weeks * Visit the clinic a total of 8 times (including screening) for checkups and testing * Keep a medication diary tracking each day they take the study drug
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Community dwelling adults age 50 years and older (approximately equal numbers of men and women). 2. Men should be sterile or agree to use contraception throughout the study. 3. Women must be postmenopausal, defined as no menses in the last 5 years (to reduce variability in change in bone resorption since menopause prompts a rapid increase in bone resorption). 4. Osteopenia will be defined as a bone mineral density (BMD) T-score at the lumbar spine, femoral neck, or total hip lower than -1 or higher than -2.5. 5. On a prescreening interview, candidates must report a usua…
Interventions
- Drugveverimer daily
8 weeks of taking 9 grams of veverimer (a powder mixed into water) daily
- Drugveverimer every other day
8 weeks of taking 9 grams of veverimer (a powder mixed into water) every other day
- OtherPlacebo
8 weeks taking 9 grams microcrystalline cellulose (powdered mixed into water) daily or every other day
Location
- Tufts Medical CenterBoston, Massachusetts