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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tufts Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Elise Danico, MS
• Email: elise.danico@tuftsmedicine.org
• Phone: 617-636-3232

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.