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?

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

Are You a Good Fit for This Trial?

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

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+