Primary HyperparathyroidismNCT03931109
Circulating miRNA in Primary Hyperparathyroidism
An observational study of Primary Hyperparathyroidism and Osteoporosis, Postmenopausal, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this study is to: 1. Analyze the expression levels of circulating (serum) miRNAs in primary hyperparathyroidism patients with and without osteoporosis, and patients with osteoporosis undergoing thyroidectomy, and to correlate with clinical markers of bone remodeling including biochemical and radiologic… Read more about this study
- Who is it for?
- Ages 50 to 100 years, women only
- Conditions the study is for
- Primary Hyperparathyroidism, Osteoporosis, Postmenopausal
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2018to 1 Jul 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: post-menopausal women diagnosed with primary hyperparathyroidism.
Who may be able to join
- post menopausal
- has had DXA scan
- has 24 hr Urine Calcium
- Elevated serum calcium
- Vitamin D above 20 ng/ml
- capable of giving informed consent
- female
- indication for biochemical primary hyperparathyroidism or an indication for partial or total thyroidectomy
Who cannot join
- history of ESRD on dialysis or renal osteodystrophy
- prior parathyroidectomy
- hyper or hypothyroid by TSH
- currently taking steroids or has been on steroids for more than 7 days in the last two years
- estrogen therapy within the last two years
- bisphosphonate therapy within the last two years
- diagnosis of Cushing's disease or Cushing's syndrome
- taking biotin within 24 hours of blood draw
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman Center for Advanced Medicine/ Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Circulating microRNA Signatures in Primary Hyperparathyroidism
The goal of this study is to: 1. Analyze the expression levels of circulating (serum) miRNAs in primary hyperparathyroidism patients with and without osteoporosis, and patients with osteoporosis undergoing thyroidectomy, and to correlate with clinical markers of bone remodeling including biochemical and radiologic studies. 2. To evaluate serum miRNA levels after treatment with parathyroidectomy.
Read the detailed description
Osteoporosis and osteopenia are chronic diseases disproportionately affecting the elderly. In the United States, the prevalence of osteoporosis is projected to increase from 10 million in 2005 to 14 million in 2025, due to population aging. Similarly, the economic cost of osteoporotic fractures is projected to increase to $25 billion by 2025. Primary hyperparathyroidism (PHPT) is one of the few reversible causes of osteoporosis and fragility fractures. PHPT is the third most common endocrine disorder, with an incidence of 27-30 per 100,000 person-years, and increasing with age; half of all patients with PHPT are post-menopausal women, a population at high risk for osteoporosis at baseline. All forms of PHPT are characterized by loss of the normal negative feedback relationship between serum calcium and parathyroid hormone (PTH) secretion, leading to hypercalcemia and hyperparathyroidism. Classic PHPT is characterized by skeletal, renal, gastrointestinal and neuropsychiatric manifestations. Skeletal manifestations of classic PHPT are mediated by osteoblast inhibition and osteoclast stimulation, leading to increased bone remodeling. The catabolic effects of chronic PTH excess may present as osteitis fibrosa cystica, brown tumors, pathologic fractures, bone pain, osteoporosis or osteopenia. Although frank osteitis fibrosa cystica is an increasingly rare presentation of PHPT in the United States, affecting 2% of patients, osteoporosis is reported in 39-63% of patients, with preferential loss of bone density in cortical sites. Fragility fractures are significantly associated with PHPT, particularly in postmenopausal women. Both decreases in bone mineral density (BMD) and fragility fractures are considered indications for parathyroidectomy in patients with asymptomatic PHPT. Parathyroidectomy has been demonstrated to improve BMD in prospective studies of PHPT patients with osteoporosis; some studies suggest that more benefit may be seen in pre-menopausal women. Current research in bone remodeling has identified microRNAs (miRNAs), novel biomarkers with both diagnostic and therapeutic potential. miRNAs are short, single stranded, non-coding RNAs which regulate posttranscriptional expression of mRNA. miRNAs have been extensively implicated in bone remodeling and homeostasis. Circulating miRNAs have been shown to correlate with fragility fractures, and are conserved across subpopulations of osteoporotic patients. miRNA panels have been suggested to have the potential to assist in diagnosis, prognosis, and are promising targets for directed therapy. Although miRNAs have been investigated in conjunction with pre-menopausal, postmenopausal, idiopathic and diabetic osteoporosis, no research to date has explored the miRNA profile of PHPT patients with osteoporosis. Similarly, although in vitro experiments have demonstrated miRNA response to bisphosphonates, no clear correlation has been established between therapeutic interventions and miRNA levels in vivo. The goal of this study is therefore two-fold; first, to analyze the expression levels of circulating miRNAs in PHPT patients with and without osteoporosis; and second, to evaluate miRNA levels after treatment with parathyroidectomy.
This is a prospective, non-randomized pilot study. Post-menopausal female subjects with and without osteoporosis, undergoing neck surgery or non-operative management will be recruited. Informed consent will be obtained. Venipuncture will be performed and serum and plasma isolated from study subjects. Analysis of serum miRNA and biochemical and clinical markers of bone remodeling will be performed. Clinical care will proceed as planned. Subjects undergoing surgery will be reassessed one year after operative intervention for miRNA and clinical and biochemical markers.
- Keywords
- Osteoporosis, primary hyperparathyroidism, miRNA, Bone remodeling, parathyroidectomy, Osteopenia, postmenopausal
- Medical subject headings
- Hyperparathyroidism, Primary, Osteoporosis, Postmenopausal, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PHPT w/ Osteoporosis | Primary hyperparathyroidism patients with osteoporosis undergoing parathyroidectomy | |
| PHPT w/o Osteoporosis | Primary hyperparathyroidism patients without osteoporosis undergoing parathyroidectomy | |
| Thyroid w/ Osteoporosis | Thyroid disease patients with osteoporosis undergoing thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
circulating microRNAs in primary hyperparathyroidism patients
Serum miRNA levels
Measured: 2019-2021
serum miRNA after parathyroidectomy
clinical markers of bone remodeling, including serum levels of bone-specific alkaline phosphatase, osteocalcin, P1NP, CTX, calcium, phosphate, Vitamin D metabolites, and PTH; urine calcium; and DXA scan
Measured: 2019-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start7 Sep 2018
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Wachtel, MD, Principal investigator, University of Pennsylvania Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931109
- Sponsor's protocol ID
- 829615
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2019
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007 Mar;22(3):465-75. doi: 10.1359/jbmr.061113.
PubMed 17144789Fraser WD. Hyperparathyroidism. Lancet. 2009 Jul 11;374(9684):145-58. doi: 10.1016/S0140-6736(09)60507-9.
PubMed 19595349Lewiecki EM, Miller PD. Skeletal effects of primary hyperparathyroidism: bone mineral density and fracture risk. J Clin Densitom. 2013 Jan-Mar;16(1):28-32. doi: 10.1016/j.jocd.2012.11.013.
PubMed 23374738Walker MD, Silverberg SJ. Primary hyperparathyroidism. Nat Rev Endocrinol. 2018 Feb;14(2):115-125. doi: 10.1038/nrendo.2017.104. Epub 2017 Sep 8.
PubMed 28885621De Geronimo S, Romagnoli E, Diacinti D, D'Erasmo E, Minisola S. The risk of fractures in postmenopausal women with primary hyperparathyroidism. Eur J Endocrinol. 2006 Sep;155(3):415-20. doi: 10.1530/eje.1.02225.
PubMed 16914595Vignali E, Viccica G, Diacinti D, Cetani F, Cianferotti L, Ambrogini E, Banti C, Del Fiacco R, Bilezikian JP, Pinchera A, Marcocci C. Morphometric vertebral fractures in postmenopausal women with primary hyperparathyroidism. J Clin Endocrinol Metab. 2009 Jul;94(7):2306-12. doi: 10.1210/jc.2008-2006. Epub 2009 Apr 28.
PubMed 19401378Bilezikian JP, Brandi ML, Eastell R, Silverberg SJ, Udelsman R, Marcocci C, Potts JT Jr. Guidelines for the management of asymptomatic primary hyperparathyroidism: summary statement from the Fourth International Workshop. J Clin Endocrinol Metab. 2014 Oct;99(10):3561-9. doi: 10.1210/jc.2014-1413. Epub 2014 Aug 27.
PubMed 25162665Lundstam K, Heck A, Godang K, Mollerup C, Baranowski M, Pernow Y, Aas T, Hessman O, Rosen T, Nordenstrom J, Jansson S, Hellstrom M, Bollerslev J; SIPH Study Group. Effect of Surgery Versus Observation: Skeletal 5-Year Outcomes in a Randomized Trial of Patients With Primary HPT (the SIPH Study). J Bone Miner Res. 2017 Sep;32(9):1907-1914. doi: 10.1002/jbmr.3177. Epub 2017 Jul 7.
PubMed 28543873Lumachi F, Camozzi V, Ermani M, DE Lotto F, Luisetto G. Bone mineral density improvement after successful parathyroidectomy in pre- and postmenopausal women with primary hyperparathyroidism: a prospective study. Ann N Y Acad Sci. 2007 Nov;1117:357-61. doi: 10.1196/annals.1402.012. Epub 2007 Jul 23.
PubMed 17646261Kim KM, Lim SK. Role of miRNAs in bone and their potential as therapeutic targets. Curr Opin Pharmacol. 2014 Jun;16:133-41. doi: 10.1016/j.coph.2014.05.001. Epub 2014 Jun 5.
PubMed 24907412Garnero P. New developments in biological markers of bone metabolism in osteoporosis. Bone. 2014 Sep;66:46-55. doi: 10.1016/j.bone.2014.05.016. Epub 2014 Jun 5.
PubMed 24909537Jing D, Hao J, Shen Y, Tang G, Li ML, Huang SH, Zhao ZH. The role of microRNAs in bone remodeling. Int J Oral Sci. 2015 Sep 14;7(3):131-43. doi: 10.1038/ijos.2015.22.
PubMed 26208037Heilmeier U, Hackl M, Skalicky S, Weilner S, Schroeder F, Vierlinger K, Patsch JM, Baum T, Oberbauer E, Lobach I, Burghardt AJ, Schwartz AV, Grillari J, Link TM. Serum miRNA Signatures Are Indicative of Skeletal Fractures in Postmenopausal Women With and Without Type 2 Diabetes and Influence Osteogenic and Adipogenic Differentiation of Adipose Tissue-Derived Mesenchymal Stem Cells In Vitro. J Bone Miner Res. 2016 Dec;31(12):2173-2192. doi: 10.1002/jbmr.2897. Epub 2016 Sep 26.
PubMed 27345526Kocijan R, Muschitz C, Geiger E, Skalicky S, Baierl A, Dormann R, Plachel F, Feichtinger X, Heimel P, Fahrleitner-Pammer A, Grillari J, Redl H, Resch H, Hackl M. Circulating microRNA Signatures in Patients With Idiopathic and Postmenopausal Osteoporosis and Fragility Fractures. J Clin Endocrinol Metab. 2016 Nov;101(11):4125-4134. doi: 10.1210/jc.2016-2365. Epub 2016 Aug 23.
PubMed 27552543Weilner S, Skalicky S, Salzer B, Keider V, Wagner M, Hildner F, Gabriel C, Dovjak P, Pietschmann P, Grillari-Voglauer R, Grillari J, Hackl M. Differentially circulating miRNAs after recent osteoporotic fractures can influence osteogenic differentiation. Bone. 2015 Oct;79:43-51. doi: 10.1016/j.bone.2015.05.027. Epub 2015 May 28.
PubMed 26026730
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating microRNA Signatures in Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT03931109
- Acronym / sponsor ID
- 829615
- Keywords
- Osteoporosis, primary hyperparathyroidism, miRNA, Bone remodeling, parathyroidectomy, Osteopenia, postmenopausal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 30 Apr 2019 (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 study is to: 1. Analyze the expression levels of circulating (serum) miRNAs in primary hyperparathyroidism patients with and without osteoporosis, and patients with osteoporosis undergoing thyroidectomy, and to correlate with clinical markers of bone remodeling including biochemical and radiologic studies. 2. To evaluate serum miRNA levels after treatment with parathyroidectomy.
Detailed description
Osteoporosis and osteopenia are chronic diseases disproportionately affecting the elderly. In the United States, the prevalence of osteoporosis is projected to increase from 10 million in 2005 to 14 million in 2025, due to population aging. Similarly, the economic cost of osteoporotic fractures is projected to increase to $25 billion by 2025. Primary hyperparathyroidism (PHPT) is one of the few reversible causes of osteoporosis and fragility fractures. PHPT is the third most common endocrine disorder, with an incidence of 27-30 per 100,000 person-years, and increasing with age; half of all patients with PHPT are post-menopausal women, a population at high risk for osteoporosis at baseline. All forms of PHPT are characterized by loss of the normal negative feedback relationship between serum calcium and parathyroid hormone (PTH) secretion, leading to hypercalcemia and hyperparathyroidism. Classic PHPT is characterized by skeletal, renal, gastrointestinal and neuropsychiatric manifestations. Skeletal manifestations of classic PHPT are mediated by osteoblast inhibition and osteoclast stimulation, leading to increased bone remodeling. The catabolic effects of chronic PTH excess may present as osteitis fibrosa cystica, brown tumors, pathologic fractures, bone pain, osteoporosis or osteopenia. Although frank osteitis fibrosa cystica is an increasingly rare presentation of PHPT in the United States, affecting 2% of patients, osteoporosis is reported in 39-63% of patients, with preferential loss of bone density in cortical sites. Fragility fractures are significantly associated with PHPT, particularly in postmenopausal women. Both decreases in bone mineral density (BMD) and fragility fractures are considered indications for parathyroidectomy in patients with asymptomatic PHPT. Parathyroidectomy has been demonstrated to improve BMD in prospective studies of PHPT patients with osteoporosis; some studies suggest that more benefit may be seen in pre-menopausal women. Current research in bone remodeling has identified microRNAs (miRNAs), novel biomarkers with both diagnostic and therapeutic potential. miRNAs are short, single stranded, non-coding RNAs which regulate posttranscriptional expression of mRNA. miRNAs have been extensively implicated in bone remodeling and homeostasis. Circulating miRNAs have been shown to correlate with fragility fractures, and are conserved across subpopulations of osteoporotic patients. miRNA panels have been suggested to have the potential to assist in diagnosis, prognosis, and are promising targets for directed therapy. Although miRNAs have been investigated in conjunction with pre-menopausal, postmenopausal, idiopathic and diabetic osteoporosis, no research to date has explored the miRNA profile of PHPT patients with osteoporosis. Similarly, although in vitro experiments have demonstrated miRNA response to bisphosphonates, no clear correlation has been established between therapeutic interventions and miRNA levels in vivo. The goal of this study is therefore two-fold; first, to analyze the expression levels of circulating miRNAs in PHPT patients with and without osteoporosis; and second, to evaluate miRNA levels after treatment with parathyroidectomy.
This is a prospective, non-randomized pilot study. Post-menopausal female subjects with and without osteoporosis, undergoing neck surgery or non-operative management will be recruited. Informed consent will be obtained. Venipuncture will be performed and serum and plasma isolated from study subjects. Analysis of serum miRNA and biochemical and clinical markers of bone remodeling will be performed. Clinical care will proceed as planned. Subjects undergoing surgery will be reassessed one year after operative intervention for miRNA and clinical and biochemical markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PHPT w/ Osteoporosis | – | –Primary hyperparathyroidism patients with osteoporosis undergoing parathyroidectomy |
| PHPT w/o Osteoporosis | – | –Primary hyperparathyroidism patients without osteoporosis undergoing parathyroidectomy |
| Thyroid w/ Osteoporosis | – | –Thyroid disease patients with osteoporosis undergoing thyroidectomy |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- post-menopausal women diagnosed with primary hyperparathyroidism.
Key inclusion criteria (8 listed)
- post menopausal
- has had DXA scan
- has 24 hr Urine Calcium
- Elevated serum calcium
- Vitamin D above 20 ng/ml
Key exclusion criteria (8 listed)
- history of ESRD on dialysis or renal osteodystrophy
- prior parathyroidectomy
- hyper or hypothyroid by TSH
- currently taking steroids or has been on steroids for more than 7 days in the last two years
- estrogen therapy within the last two years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
circulating microRNAs in primary hyperparathyroidism patients
Time frame: 2019-2021
Serum miRNA levels
serum miRNA after parathyroidectomy
Time frame: 2019-2021
clinical markers of bone remodeling, including serum levels of bone-specific alkaline phosphatase, osteocalcin, P1NP, CTX, calcium, phosphate, Vitamin D metabolites, and PTH; urine calcium; and DXA scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 17144789Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007 Mar;22(3):465-75. doi: 10.1359/jbmr.061113.
- Background: PubMed 19595349Fraser WD. Hyperparathyroidism. Lancet. 2009 Jul 11;374(9684):145-58. doi: 10.1016/S0140-6736(09)60507-9.
- Background: PubMed 23374738Lewiecki EM, Miller PD. Skeletal effects of primary hyperparathyroidism: bone mineral density and fracture risk. J Clin Densitom. 2013 Jan-Mar;16(1):28-32. doi: 10.1016/j.jocd.2012.11.013.
- Background: PubMed 28885621Walker MD, Silverberg SJ. Primary hyperparathyroidism. Nat Rev Endocrinol. 2018 Feb;14(2):115-125. doi: 10.1038/nrendo.2017.104. Epub 2017 Sep 8.
- Background: PubMed 16914595De Geronimo S, Romagnoli E, Diacinti D, D'Erasmo E, Minisola S. The risk of fractures in postmenopausal women with primary hyperparathyroidism. Eur J Endocrinol. 2006 Sep;155(3):415-20. doi: 10.1530/eje.1.02225.
- Background: PubMed 19401378Vignali E, Viccica G, Diacinti D, Cetani F, Cianferotti L, Ambrogini E, Banti C, Del Fiacco R, Bilezikian JP, Pinchera A, Marcocci C. Morphometric vertebral fractures in postmenopausal women with primary hyperparathyroidism. J Clin Endocrinol Metab. 2009 Jul;94(7):2306-12. doi: 10.1210/jc.2008-2006. Epub 2009 Apr 28.
- Background: PubMed 25162665Bilezikian JP, Brandi ML, Eastell R, Silverberg SJ, Udelsman R, Marcocci C, Potts JT Jr. Guidelines for the management of asymptomatic primary hyperparathyroidism: summary statement from the Fourth International Workshop. J Clin Endocrinol Metab. 2014 Oct;99(10):3561-9. doi: 10.1210/jc.2014-1413. Epub 2014 Aug 27.
- Background: PubMed 28543873Lundstam K, Heck A, Godang K, Mollerup C, Baranowski M, Pernow Y, Aas T, Hessman O, Rosen T, Nordenstrom J, Jansson S, Hellstrom M, Bollerslev J; SIPH Study Group. Effect of Surgery Versus Observation: Skeletal 5-Year Outcomes in a Randomized Trial of Patients With Primary HPT (the SIPH Study). J Bone Miner Res. 2017 Sep;32(9):1907-1914. doi: 10.1002/jbmr.3177. Epub 2017 Jul 7.
- Background: PubMed 17646261Lumachi F, Camozzi V, Ermani M, DE Lotto F, Luisetto G. Bone mineral density improvement after successful parathyroidectomy in pre- and postmenopausal women with primary hyperparathyroidism: a prospective study. Ann N Y Acad Sci. 2007 Nov;1117:357-61. doi: 10.1196/annals.1402.012. Epub 2007 Jul 23.
- Background: PubMed 24907412Kim KM, Lim SK. Role of miRNAs in bone and their potential as therapeutic targets. Curr Opin Pharmacol. 2014 Jun;16:133-41. doi: 10.1016/j.coph.2014.05.001. Epub 2014 Jun 5.
- Background: PubMed 24909537Garnero P. New developments in biological markers of bone metabolism in osteoporosis. Bone. 2014 Sep;66:46-55. doi: 10.1016/j.bone.2014.05.016. Epub 2014 Jun 5.
- Background: PubMed 26208037Jing D, Hao J, Shen Y, Tang G, Li ML, Huang SH, Zhao ZH. The role of microRNAs in bone remodeling. Int J Oral Sci. 2015 Sep 14;7(3):131-43. doi: 10.1038/ijos.2015.22.
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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. This study is not recruiting at the moment.
Heather Wachtel, MD principal investigator
University of Pennsylvania Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperparathyroidism and Osteoporosis, Postmenopausal, run by University of Pennsylvania 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 1 Aug 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circulating microRNAs in primary hyperparathyroidism patients (time frame: 2019-2021). The study lists 2 primary outcomes in all. 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 NCT03931109, which also lists 17 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 1 Aug 2024; AzTrials last refreshed its copy on 27 Oct 2026.