60 Participants NeededMy employer runs this trial

Veverimer for Osteopenia

ED
Overseen ByElise Danico, MS
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Tufts Medical Center

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called veverimer, a potential new drug, to determine if it can reduce bone loss in individuals with osteopenia, a condition where bones are weaker than normal. Researchers aim to discover if veverimer lowers acid levels in urine, potentially slowing bone resorption (the breakdown of bone tissue). The trial will also assess veverimer's safety and its effects on bone health and physical performance. Participants should have osteopenia and follow a diet high in acid but should not have conditions like asthma or diabetes requiring insulin. As a Phase 1 trial, this research focuses on understanding how veverimer works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

You won't have to stop taking your current medications, but you must agree not to change your medication use during the study.

Is there any evidence suggesting that veverimer is likely to be safe for humans?

Research has shown that veverimer is generally well-tolerated. In earlier studies, only a small number of patients experienced serious side effects. Specifically, about 2% of those taking veverimer had serious issues, compared to 5% in the placebo group. Common side effects included headaches, diarrhea, and gas, similar to those in people not taking the drug. Studies found no interactions with other medications, suggesting veverimer is quite safe to use. However, as with any treatment, individual experiences may vary.12345

Why do researchers think this study treatment might be promising for osteopenia?

Most treatments for osteopenia focus on increasing bone density through medications like bisphosphonates or hormone therapies. Veverimer is unique because it operates differently, targeting the body's acid-base balance. Researchers are excited about Veverimer because it has a novel mechanism of action that might improve bone health by reducing metabolic acidosis, which is a less explored pathway in osteopenia treatment. This approach could offer a new avenue for people who don't respond well to existing medications or who experience side effects.

What evidence suggests that veverimer might be an effective treatment for osteopenia?

Research has shown that veverimer may help treat issues related to metabolic acidosis. In earlier studies, veverimer successfully raised bicarbonate levels in the blood, indicating a better acid balance in the body. This is important because a healthier acid balance might help reduce bone loss. Patients with chronic kidney disease who used veverimer reported better physical function, suggesting it could improve overall health. Although direct evidence on veverimer for osteopenia is limited, its ability to lower acid levels makes it a possible option for reducing bone loss in this condition. Participants in this trial will receive either veverimer 9 g/day, veverimer 9 g/every other day, or a placebo to evaluate its effects on osteopenia.12678

Are You a Good Fit for This Trial?

This trial is for men and postmenopausal women aged 50 or older with osteopenia (mildly low bone density), normal kidney function, and a diet high in acid. Participants must not change their exercise, medication, supplement use, eating habits, or weight during the study.

Inclusion Criteria

5. On a prescreening interview, candidates must report a usual diet associated with an acid load by our validated short questionnaire.
My kidney function is normal or only mildly reduced.
I agree to keep my exercise and medication routines the same during the study.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants take veverimer or placebo every day or every other day for 8 weeks

8 weeks
7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Veverimer

Trial Overview

The study tests veverimer taken daily or every other day versus placebo over 8 weeks to see if it reduces acid in urine and slows bone loss. Participants are randomly assigned to groups and attend regular clinic visits for monitoring.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Veverimer 9 g/every other dayExperimental Treatment1 Intervention
Group II: Veverimer 9 g/dayExperimental Treatment1 Intervention
Group III: Placebo (microcrystalline cellulose with 0.075% yellow ferric oxide)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials
264
Recruited
264,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31248662/

Long-term safety and efficacy of veverimer in patients with ...

Veverimer safely and effectively corrected metabolic acidosis and improved subjective and objective measures of physical function.

Veverimer to Decrease Net Acid Excretion and Bone ...

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 ...

Long-term safety and efficacy of veverimer in patients with ...

Serious adverse events occurred in 2% of veverimer-treated patients and in 5% of placebo patients (two of whom died). Renal system adverse events were reported ...

Veverimer for Osteopenia

The goal of this clinical trial is to learn if veverimer will reduce urinary net acid excretion leading to reduced bone resorption in ...

Efficacy and Safety of Veverimer in the Treatment ...

The analysis demonstrated that veverimer use was effective against acidosis in patients with CKD, with a mean increase in serum bicarbonate ...

Efficacy and Safety of Veverimer in the Treatment of Metabolic ...

For safety outcomes, both groups exhibited similar risks for developing headache, diarrhea, flatulence, and hyperkalemia. In conclusion, current ...

Long-term safety and efficacy of veverimer in patients with ...

The primary endpoint was safety; the four secondary endpoints assessed the long-term effects of veverimer on serum bicarbonate concentration and ...

Effects of Veverimer in Older Adults With CKD and ...

No veverimer-drug interactions have been observed in human and in vitro studies. Here, we report the results of a post hoc analysis of the ...