Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
ConditionOsteopenia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50+
SponsorTufts Medical Center
About 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Community dwelling adults age 50 years and older (approximately equal numbers of men and women).
Men should be sterile or agree to use contraception throughout the study.
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).
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.
Disqualifiers
Normal BMD T-scores at all spine and hip sites, osteoporosis based on BMD T-score of -2.5 or less
Respiratory illness in last month
Chronic obstructive pulmonary disease (COPD)
Asthma
Trial design
Design model
Parallel
Treatments tested in this trial
veverimer daily
Drug8 weeks of taking 9 grams of veverimer (a powder mixed into water) daily
veverimer every other day
Drug8 weeks of taking 9 grams of veverimer (a powder mixed into water) every other day
Placebo
Other intervention8 weeks taking 9 grams microcrystalline cellulose (powdered mixed into water) daily or every other day
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Veverimer 9 g/dayExperimental treatment 1 intervention
Group B: Veverimer 9 g/every other dayExperimental treatment 1 intervention
Group C: Placebo (microcrystalline cellulose with 0.075% yellow ferric oxide)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
24-hr urinary net acid excretion
Time frame
measured at screening, week 2, week 8 and week 8 +1daySecondary outcomes
1
Serum bicarbonate level
Time frame
measured at screening, week 0, week 1, week 2, week 4, week 82
Serum potassium level
Time frame
measured at screening, week 0, week 1, week 2, week 4, week 83
Serum C-telopeptide level
Time frame
measured at week 0, week 2, week 84
Serum procollagen type 1 N-propeptide level
Time frame
measured at week 0 and week 8Other outcomes
1
Sit-to-stand time
Sit-to-stand time with higher times indicating lower strength and function
Time frame
measured at week 0 and week 82
Gait speed
6-meter walking speed with higher time indicating lower function
Time frame
measured at week 0 and week 83
Time-up-and-go time
time-up-and-go with 3 meter walk with higher time indicating lower function
Time frame
measured at week 0 and week 84
24-hr urinary pH
Time frame
measured at screening, week 2, week 8, and week 8 +1daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Tufts Medical Center
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov