OsteopeniaPhase 1NCT07473713
Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
A Phase 1 study testing veverimer daily and veverimer every other day in people with Osteopenia, run by Tufts Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteopenia
- What is being tested?
- veverimer daily and veverimer every other day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 1 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Elise Danico, 617-636-3273, elise.danico@tuftsmedicine.org
Lisa Ceglia, MD MS
About this study
Official title: Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia: a Dose-finding Randomized Controlled 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.
Read more
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
- Conditions
- Osteopenia
- Being tested
- veverimer daily, veverimer every other day, Placebo
- Keywords
- Osteopenia, veverimer
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
veverimer dailyDrug
8 weeks of taking 9 grams of veverimer (a powder mixed into water) daily
veverimer every other dayDrug
8 weeks of taking 9 grams of veverimer (a powder mixed into water) every other day
PlaceboOther
8 weeks taking 9 grams microcrystalline cellulose (powdered mixed into water) daily or every other day
| Study group | Role | What they receive |
|---|---|---|
| Veverimer 9 g/day | Experimental | Not described Receives: Drug: veverimer daily |
| Veverimer 9 g/every other day | Experimental | Not described Receives: Drug: veverimer every other day |
| Placebo (microcrystalline cellulose with 0.075% yellow ferric oxide) | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hr urinary net acid excretion
Measured: measured at screening, week 2, week 8 and week 8 +1day
Secondary outcomes (4)
Serum bicarbonate level
Measured: measured at screening, week 0, week 1, week 2, week 4, week 8
Serum potassium level
Measured: measured at screening, week 0, week 1, week 2, week 4, week 8
Serum C-telopeptide level
Measured: measured at week 0, week 2, week 8
Serum procollagen type 1 N-propeptide level
Measured: measured at week 0 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Apr 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473713
- Sponsor's protocol ID
- STUDY00006557
- Other IDs
- 1R61AR085647-01
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dawson-Hughes B, Castaneda-Sceppa C, Harris SS, Palermo NJ, Cloutier G, Ceglia L, Dallal GE. Impact of supplementation with bicarbonate on lower-extremity muscle performance in older men and women. Osteoporos Int. 2010 Jul;21(7):1171-9. doi: 10.1007/s00198-009-1049-0. Epub 2009 Sep 1.
PubMed 19727904Bauer DC, Garnero P, Bilezikian JP, Greenspan SL, Ensrud KE, Rosen CJ, Palermo L, Black DM. Short-term changes in bone turnover markers and bone mineral density response to parathyroid hormone in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2006 Apr;91(4):1370-5. doi: 10.1210/jc.2005-1712. Epub 2006 Jan 31.
PubMed 16449339Chen P, Satterwhite JH, Licata AA, Lewiecki EM, Sipos AA, Misurski DM, Wagman RB. Early changes in biochemical markers of bone formation predict BMD response to teriparatide in postmenopausal women with osteoporosis. J Bone Miner Res. 2005 Jun;20(6):962-70. doi: 10.1359/JBMR.050105. Epub 2005 Jan 18.
PubMed 15883636Niimi R, Kono T, Nishihara A, Hasegawa M, Matsumine A, Nakamura T, Kono T, Sudo A. An algorithm using the early changes in PINP to predict the future BMD response for patients treated with daily teriparatide. Osteoporos Int. 2014 Jan;25(1):377-84. doi: 10.1007/s00198-013-2426-2. Epub 2013 Jun 29.
PubMed 23812597Kotlarczyk MP, Perera S, Resnick NM, Nace DA, Greenspan SL. Early changes in bone turnover predict longer-term changes in bone mineral density but not trabecular bone score in frail older women. Arch Osteoporos. 2020 May 26;15(1):79. doi: 10.1007/s11657-020-00749-w.
PubMed 32458096Vasikaran S, Eastell R, Bruyere O, Foldes AJ, Garnero P, Griesmacher A, McClung M, Morris HA, Silverman S, Trenti T, Wahl DA, Cooper C, Kanis JA; IOF-IFCC Bone Marker Standards Working Group. Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards. Osteoporos Int. 2011 Feb;22(2):391-420. doi: 10.1007/s00198-010-1501-1. Epub 2010 Dec 24.
PubMed 21184054Jajoo R, Song L, Rasmussen H, Harris SS, Dawson-Hughes B. Dietary acid-base balance, bone resorption, and calcium excretion. J Am Coll Nutr. 2006 Jun;25(3):224-30. doi: 10.1080/07315724.2006.10719536.
PubMed 16766781JORGENSEN K. Titrimetric determination of the net excretion of acid/base in urine. Scand J Clin Lab Invest. 1957;9(3):287-91. doi: 10.3109/00365515709079972. No abstract available.
PubMed 13495348Shea MK, Gilhooly CH, Dawson-Hughes B. Food groups associated with measured net acid excretion in community-dwelling older adults. Eur J Clin Nutr. 2017 Mar;71(3):420-424. doi: 10.1038/ejcn.2016.195. Epub 2016 Oct 19.
PubMed 27759073Parsell D, Shao J, Guttendorf R, Mathur V, Li E, Wu YS, Tsao L, Tabakman S, Stasiv Y, Lee A, Biyani K, Klaerner G. Assessment of the Potential for Veverimer Drug-Drug Interactions. Drug Metab Dispos. 2021 Jul;49(7):490-500. doi: 10.1124/dmd.121.000366. Epub 2021 May 24.
PubMed 34031138Frick KK, Krieger NS, Nehrke K, Bushinsky DA. Metabolic acidosis increases intracellular calcium in bone cells through activation of the proton receptor OGR1. J Bone Miner Res. 2009 Feb;24(2):305-13. doi: 10.1359/jbmr.081015.
PubMed 18847331Tomura H, Mogi C, Sato K, Okajima F. Proton-sensing and lysolipid-sensitive G-protein-coupled receptors: a novel type of multi-functional receptors. Cell Signal. 2005 Dec;17(12):1466-76. doi: 10.1016/j.cellsig.2005.06.002.
PubMed 16014326Ludwig MG, Vanek M, Guerini D, Gasser JA, Jones CE, Junker U, Hofstetter H, Wolf RM, Seuwen K. Proton-sensing G-protein-coupled receptors. Nature. 2003 Sep 4;425(6953):93-8. doi: 10.1038/nature01905.
PubMed 12955148Arnett TR, Dempster DW. Effect of pH on bone resorption by rat osteoclasts in vitro. Endocrinology. 1986 Jul;119(1):119-24. doi: 10.1210/endo-119-1-119.
PubMed 3720660Komarova SV, Pereverzev A, Shum JW, Sims SM, Dixon SJ. Convergent signaling by acidosis and receptor activator of NF-kappaB ligand (RANKL) on the calcium/calcineurin/NFAT pathway in osteoclasts. Proc Natl Acad Sci U S A. 2005 Feb 15;102(7):2643-8. doi: 10.1073/pnas.0406874102. Epub 2005 Feb 4.
PubMed 15695591
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia: a Dose-finding Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07473713
- Acronym / sponsor ID
- STUDY00006557
- Conditions
- Osteopenia
- Keywords
- Osteopenia, veverimer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Veverimer 9 g/day | Experimental | Drug: veverimer daily |
| Veverimer 9 g/every other day | Experimental | Drug: veverimer every other day |
| Placebo (microcrystalline cellulose with 0.075% yellow ferric oxide) | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| veverimer daily8 weeks of taking 9 grams of veverimer (a powder mixed into water) daily | Drug | Veverimer 9 g/day |
| veverimer every other day8 weeks of taking 9 grams of veverimer (a powder mixed into water) every other day | Drug | Veverimer 9 g/every other day |
| Placebo8 weeks taking 9 grams microcrystalline cellulose (powdered mixed into water) daily or every other day | Other | Placebo (microcrystalline cellulose with 0.075% yellow ferric oxide) |
Primary outcome
24-hr urinary net acid excretion
Time frame: measured at screening, week 2, week 8 and week 8 +1day
4 secondary outcomes
Serum bicarbonate level
Time frame: measured at screening, week 0, week 1, week 2, week 4, week 8
Serum potassium level
Time frame: measured at screening, week 0, week 1, week 2, week 4, week 8
Serum C-telopeptide level
Time frame: measured at week 0, week 2, week 8
Serum procollagen type 1 N-propeptide level
Time frame: measured at week 0 and week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 19727904Dawson-Hughes B, Castaneda-Sceppa C, Harris SS, Palermo NJ, Cloutier G, Ceglia L, Dallal GE. Impact of supplementation with bicarbonate on lower-extremity muscle performance in older men and women. Osteoporos Int. 2010 Jul;21(7):1171-9. doi: 10.1007/s00198-009-1049-0. Epub 2009 Sep 1.
- Background: PubMed 16449339Bauer DC, Garnero P, Bilezikian JP, Greenspan SL, Ensrud KE, Rosen CJ, Palermo L, Black DM. Short-term changes in bone turnover markers and bone mineral density response to parathyroid hormone in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2006 Apr;91(4):1370-5. doi: 10.1210/jc.2005-1712. Epub 2006 Jan 31.
- Background: PubMed 15883636Chen P, Satterwhite JH, Licata AA, Lewiecki EM, Sipos AA, Misurski DM, Wagman RB. Early changes in biochemical markers of bone formation predict BMD response to teriparatide in postmenopausal women with osteoporosis. J Bone Miner Res. 2005 Jun;20(6):962-70. doi: 10.1359/JBMR.050105. Epub 2005 Jan 18.
- Background: PubMed 23812597Niimi R, Kono T, Nishihara A, Hasegawa M, Matsumine A, Nakamura T, Kono T, Sudo A. An algorithm using the early changes in PINP to predict the future BMD response for patients treated with daily teriparatide. Osteoporos Int. 2014 Jan;25(1):377-84. doi: 10.1007/s00198-013-2426-2. Epub 2013 Jun 29.
- Background: PubMed 32458096Kotlarczyk MP, Perera S, Resnick NM, Nace DA, Greenspan SL. Early changes in bone turnover predict longer-term changes in bone mineral density but not trabecular bone score in frail older women. Arch Osteoporos. 2020 May 26;15(1):79. doi: 10.1007/s11657-020-00749-w.
- Background: PubMed 21184054Vasikaran S, Eastell R, Bruyere O, Foldes AJ, Garnero P, Griesmacher A, McClung M, Morris HA, Silverman S, Trenti T, Wahl DA, Cooper C, Kanis JA; IOF-IFCC Bone Marker Standards Working Group. Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards. Osteoporos Int. 2011 Feb;22(2):391-420. doi: 10.1007/s00198-010-1501-1. Epub 2010 Dec 24.
- Background: PubMed 16766781Jajoo R, Song L, Rasmussen H, Harris SS, Dawson-Hughes B. Dietary acid-base balance, bone resorption, and calcium excretion. J Am Coll Nutr. 2006 Jun;25(3):224-30. doi: 10.1080/07315724.2006.10719536.
- Background: PubMed 13495348JORGENSEN K. Titrimetric determination of the net excretion of acid/base in urine. Scand J Clin Lab Invest. 1957;9(3):287-91. doi: 10.3109/00365515709079972. No abstract available.
- Background: PubMed 27759073Shea MK, Gilhooly CH, Dawson-Hughes B. Food groups associated with measured net acid excretion in community-dwelling older adults. Eur J Clin Nutr. 2017 Mar;71(3):420-424. doi: 10.1038/ejcn.2016.195. Epub 2016 Oct 19.
- Background: PubMed 34031138Parsell D, Shao J, Guttendorf R, Mathur V, Li E, Wu YS, Tsao L, Tabakman S, Stasiv Y, Lee A, Biyani K, Klaerner G. Assessment of the Potential for Veverimer Drug-Drug Interactions. Drug Metab Dispos. 2021 Jul;49(7):490-500. doi: 10.1124/dmd.121.000366. Epub 2021 May 24.
- Background: PubMed 18847331Frick KK, Krieger NS, Nehrke K, Bushinsky DA. Metabolic acidosis increases intracellular calcium in bone cells through activation of the proton receptor OGR1. J Bone Miner Res. 2009 Feb;24(2):305-13. doi: 10.1359/jbmr.081015.
- Background: PubMed 16014326Tomura H, Mogi C, Sato K, Okajima F. Proton-sensing and lysolipid-sensitive G-protein-coupled receptors: a novel type of multi-functional receptors. Cell Signal. 2005 Dec;17(12):1466-76. doi: 10.1016/j.cellsig.2005.06.002.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing veverimer daily and veverimer every other day in people with Osteopenia, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise Danico, MS (617-636-3232, elise.danico@tuftsmedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hr urinary net acid excretion (time frame: measured at screening, week 2, week 8 and week 8 +1day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07473713, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.