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New treatment option for Osteopenia
Official title Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
ClinicalTrials.gov ID: NCT07473713
What this study is testing
What is veverimer daily?
veverimer daily is an investigational medicine, given as an once-daily, being studied as a potential treatment for osteopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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...
- 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.
- On a prescreening interview, candidates must report a usual diet associated with an acid load by our validated short questionnaire.
You likely can't join if
- 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
- Nausea/vomiting in last month
- Dysphagia
See the full eligibility criteria
- 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.
- On a prescreening interview, candidates must report a usual diet associated with an acid load by our validated short questionnaire.
- Estimated glomerular filtration rate (eGFR) must be 45 ml/min or greater.
- Participants must agree not to change their exercise pattern or medication use during the study.
- 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.
- Participants must agree to not change their eating habits or intentionally change their weight.
- 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
- Nausea/vomiting in last month
- Dysphagia
- Malabsorption
- Inflammatory bowel disease
- Chronic diarrhea (defined as loose bowel movements daily) or constipation (≤ 2 stools per week)
- Insulin-requiring diabetes or fasting plasma glucose \>125 mg/dl
- Untreated thyroid disease
- Cirrhosis
- Current unstable heart disease
- Malignancy (except non-melanoma skin cancer) or cancer therapy in last year
- Alcohol use \>2 drinks/day.
- Individuals who are unable to provide informed consent due to cognitive impairment.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.