Veverimer to reduce acid load and slow bone loss in adults with osteopenia

Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia: a Dose-finding Randomized Controlled Trial

This trial will test whether taking veverimer, compared with placebo, lowers urinary acid levels and reduces bone breakdown in adults aged 50 and older with osteopenia.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Tufts Medical Center (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07473713 on ClinicalTrials.gov

What this trial studies

Adults with osteopenia will take either veverimer (daily or every other day) or a matching placebo for 8 weeks while attending eight clinic visits including screening. The study measures 24-hour urinary net acid excretion as the primary physiologic outcome and monitors safety through serum bicarbonate and potassium. Secondary outcomes include markers of bone resorption and formation, and exploratory measures of physical performance. Participants will keep a medication diary and agree not to change exercise, medication, or supplement patterns during the trial.

Who should consider this trial

Good fit: Community-dwelling adults aged 50 years or older with osteopenia (BMD T-score between -1 and -2.5), an eGFR ≥45 ml/min, postmenopausal women or men who are sterile or agree to contraception, and who report a usual diet with an acid load are ideal candidates.

Not a fit: People with osteoporosis (T-score ≤ -2.5), significant kidney impairment (eGFR <45 ml/min), those who cannot avoid antacids or change supplements/medications as required, or premenopausal women are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, veverimer may lower acid load and slow bone resorption, which could help preserve bone health and potentially reduce long-term fracture risk.

How similar studies have performed: Previous veverimer trials in patients with metabolic acidosis and chronic kidney disease have shown it can raise serum bicarbonate, but its specific effects on bone in otherwise healthy adults with osteopenia are less well studied.

Eligibility criteria

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 usual diet associated with an acid load by our validated short questionnaire.
6. Estimated glomerular filtration rate (eGFR) must be 45 ml/min or greater.
7. Participants must agree not to change their exercise pattern or medication use during the study.
8. Participants must agree not to change their pattern of supplement use and not to use antacids during the study because most calcium supplements and other antacids add alkali.
9. Participants must agree to not change their eating habits or intentionally change their weight.

Exclusion Criteria:

1. Normal BMD T-scores at all spine and hip sites, osteoporosis based on BMD T-score of -2.5 or less
2. Respiratory illness in last month
3. Chronic obstructive pulmonary disease (COPD)
4. Asthma
5. Nausea/vomiting in last month
6. Dysphagia
7. Malabsorption
8. Inflammatory bowel disease
9. Chronic diarrhea (defined as loose bowel movements daily) or constipation (≤ 2 stools per week)
10. Insulin-requiring diabetes or fasting plasma glucose \>125 mg/dl
11. Untreated thyroid disease
12. Cirrhosis
13. Current unstable heart disease
14. Malignancy (except non-melanoma skin cancer) or cancer therapy in last year
15. Alcohol use \>2 drinks/day.
16. Individuals who are unable to provide informed consent due to cognitive impairment.

Where this trial is running

Boston, Massachusetts

• Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Elise Danico, MS

Conditions Osteopenia; veverimer