Postmenopausal OsteoporosisNCT05347082
Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment
A study testing Cholecalciferol in people with Postmenopausal Osteoporosis and Postmenopause, run by Hospital Regional 1o de Octubre at 1 site in Mexico.
Trial summary
Recently, an increase in the prevalence of hyperparathyroidism and hypovitaminosis D in postmenopause women has been occurring in Mexico and the world. Chronic exposure to the parathyroid hormone (PTH) is catabolic for the bone, worsening the state of osteoporosis. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postmenopausal Osteoporosis, Postmenopause, Hyperparathyroidism, Secondary
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteMexico
- Study dates
- 29 Apr 2021to 20 Feb 2022
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acceptance to participate in the study with informed consent.
- Postmenopausal osteoporosis or osteopenia.
- Primary or secondary hyperparathyroidism.
- Insufficiency or deficiency of vitamin D.
- Multi-treated postmenopausal osteoporosis.
- Postmenopausal osteoporosis without treatment.
Who cannot join
- Different osteoporosis aetiology not related to oestrogenic deficiency.
- Thyroid pathology.
- Previous treatment with vitamin D, thiazide diuretics, lithium, Teriparatide or glucocorticoids.
- Known allergies to vitamin D.
- Addison's disease, pheochromocytoma, and depressive disorders.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
Mexico City, 07300
About this study
Official title: Resolution of Hyperparathyroidism With High-dose Vitamin D Improves Osteoporosis in Multi-treated Postmenopausal Women
Recently, an increase in the prevalence of hyperparathyroidism and hypovitaminosis D in postmenopause women has been occurring in Mexico and the world. Chronic exposure to the parathyroid hormone (PTH) is catabolic for the bone, worsening the state of osteoporosis. However, it is unclear whether these conditions could significantly improve bone mineral density (BMD). In the present work, it was shown that the resolution of hyperparathyroidism in postmenopausal women improves osteoporosis.
Read the detailed description
This study was an open clinical trial conducted in Mexican women diagnosed with postmenopausal osteoporosis and hyperparathyroidism associated or not with hypovitaminosis D from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE).
An integral clinical evaluation with PTH and vitamin D measurement was first done to determine the frequency of primary hyperparathyroidism and hypovitaminosis D. Likewise, a thyroid ultrasound was done. Then, 8000 IU of vitamin D were orally administrated for four weeks. Statical analysis was performed using PAST 3.0 and GraphPad Prism 8.4.3. software. The arithmetic median (µ) and standard deviation (S.D.) were calculated using Excel-Word. Graphics were constructed with GraphPad Prism 8.4.3 and tables with Excel-Word. Categorical variables were analysed with chi-squared or Fisher exact test depending on the number of participants in each cell. Normality was determined using the Shapiro-Wilk test. To compare two paired samples, the Wilcoxon signed-rank test was utilized. To perform correlations, the Spearman correlation coefficient was used. The assigned α value for this study was <0.05. In all cases, if a Montecarlo permutation was available, the exact p-value was taken instead of the raw p-value.
- Conditions
- Postmenopausal Osteoporosis, Postmenopause, Hyperparathyroidism, Secondary, Hypovitaminosis D, Hyperparathyroidism, Primary
- Being tested
- Cholecalciferol
- Keywords
- Vitamin D, Postmenopause, Osteopenia, Osteoporosis, Bone Mineral Density, Hyperparathyroidism
- Medical subject headings
- Osteoporosis, Postmenopausal, Hyperparathyroidism, Secondary, Vitamin D Deficiency, Hyperparathyroidism, Primary, Bone Diseases, Metabolic, Osteoporosis, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Histofil®
Tablets of 4000 IU
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | 8000 IU of vitamin D orally, once a day, for four weeks. Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Remission of Hyperparathyroidism
Clinical remission of hyperparathyroidism was evaluated after treatment.
Measured: 4 weeks
Number of Participants with Remission of Hypovitaminosis D
Clinical remission of vitamin D deficiency or insufficiency were evaluated after treatment.
Measured: 4 weeks.
Change from baseline hip T score at 4 weeks
Osteoporosis in the hip was determined by a T score greater than -2.5 and osteopenia was determined by a T score between -1 to -2.4.
Measured: 4 weeks
Change from baseline lumbar spine T score at 4 weeks
Osteoporosis in the lumbar spine was determined by a T-score greater than -2.5 and osteopenia was determined by a T-score between -1 and -2.4.
Measured: 4 weeks
Secondary outcomes (1)
Change from baseline general T score at 4 weeks
Osteoporosis was determined by a T-score greater than -2.5 either in the hip or in the lumbar spine and osteopenia was determined by a T-score between -1 and -2.4 either in the hip or in the lumbar spine.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start29 Apr 2021
- Primary completion29 Dec 2021
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 47 participants who met the inclusion criteria were included and all received 8000 IU of vitamin D orally for four weeks.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Regional 1o de Octubre
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, National Polytechnic Institute, Mexico
- Responsible party
- Sponsor
- Investigators
- Juan M Ocampo Godínez, M.D., Ph.D., Study director, Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]Patricia Loranca-Moreno, M.D., M.Sc., Study director, Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.Paula M Sánchez-Tinoco, M.D., Principal investigator, Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347082
- Sponsor's protocol ID
- 120.2021
- Status last verified
- Apr 2022
- First submitted
- 17 Apr 2022
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cosman F, de Beur SJ, LeBoff MS, Lewiecki EM, Tanner B, Randall S, Lindsay R; National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014 Oct;25(10):2359-81. doi: 10.1007/s00198-014-2794-2. Epub 2014 Aug 15.
PubMed 25182228Lundgren E, Hagstrom EG, Lundin J, Winnerback K, Roos J, Ljunghall S, Rastad J. Primary hyperparathyroidism revisited in menopausal women with serum calcium in the upper normal range at population-based screening 8 years ago. World J Surg. 2002 Aug;26(8):931-6. doi: 10.1007/s00268-002-6621-0. Epub 2002 Jun 6.
PubMed 12045863Grey A, Lucas J, Horne A, Gamble G, Davidson JS, Reid IR. Vitamin D repletion in patients with primary hyperparathyroidism and coexistent vitamin D insufficiency. J Clin Endocrinol Metab. 2005 Apr;90(4):2122-6. doi: 10.1210/jc.2004-1772. Epub 2005 Jan 11.
PubMed 15644400Tucci JR. Vitamin D therapy in patients with primary hyperparathyroidism and hypovitaminosis D. Eur J Endocrinol. 2009 Jul;161(1):189-93. doi: 10.1530/EJE-08-0901. Epub 2009 Apr 21.
PubMed 19383807Contreras-Manzano A, Villalpando S, Robledo-Perez R. Vitamin D status by sociodemographic factors and body mass index in Mexican women at reproductive age. Salud Publica Mex. 2017 Sep-Oct;59(5):518-525. doi: 10.21149/8080.
PubMed 29267648Goltzman D. Functions of vitamin D in bone. Histochem Cell Biol. 2018 Apr;149(4):305-312. doi: 10.1007/s00418-018-1648-y. Epub 2018 Feb 12.
PubMed 29435763Lips P, van Schoor NM. The effect of vitamin D on bone and osteoporosis. Best Pract Res Clin Endocrinol Metab. 2011 Aug;25(4):585-91. doi: 10.1016/j.beem.2011.05.002.
PubMed 21872800Lips P. Vitamin D deficiency and secondary hyperparathyroidism in the elderly: consequences for bone loss and fractures and therapeutic implications. Endocr Rev. 2001 Aug;22(4):477-501. doi: 10.1210/edrv.22.4.0437.
PubMed 11493580Recker RR, Kendler D, Recknor CP, Rooney TW, Lewiecki EM, Utian WH, Cauley JA, Lorraine J, Qu Y, Kulkarni PM, Gaich CL, Wong M, Plouffe L Jr, Stock JL. Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass. Bone. 2007 Apr;40(4):843-51. doi: 10.1016/j.bone.2006.11.001. Epub 2006 Dec 19.
PubMed 17182297Manson JE, Hsia J, Johnson KC, Rossouw JE, Assaf AR, Lasser NL, Trevisan M, Black HR, Heckbert SR, Detrano R, Strickland OL, Wong ND, Crouse JR, Stein E, Cushman M; Women's Health Initiative Investigators. Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med. 2003 Aug 7;349(6):523-34. doi: 10.1056/NEJMoa030808.
PubMed 12904517Watson J, Wise L, Green J. Prescribing of hormone therapy for menopause, tibolone, and bisphosphonates in women in the UK between 1991 and 2005. Eur J Clin Pharmacol. 2007 Sep;63(9):843-9. doi: 10.1007/s00228-007-0320-6. Epub 2007 Jun 28.
PubMed 17598097Davis S, Martyn-St James M, Sanderson J, Stevens J, Goka E, Rawdin A, Sadler S, Wong R, Campbell F, Stevenson M, Strong M, Selby P, Gittoes N. A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures. Health Technol Assess. 2016 Oct;20(78):1-406. doi: 10.3310/hta20780.
PubMed 27801641Paggiosi MA, Peel N, McCloskey E, Walsh JS, Eastell R. Comparison of the effects of three oral bisphosphonate therapies on the peripheral skeleton in postmenopausal osteoporosis: the TRIO study. Osteoporos Int. 2014 Dec;25(12):2729-41. doi: 10.1007/s00198-014-2817-z. Epub 2014 Jul 30.
PubMed 25074351Chen LX, Zhou ZR, Li YL, Ning GZ, Zhang TS, Zhang D, Feng SQ. Comparison of Bone Mineral Density in Lumbar Spine and Fracture Rate among Eight Drugs in Treatments of Osteoporosis in Men: A Network Meta-Analysis. PLoS One. 2015 May 26;10(5):e0128032. doi: 10.1371/journal.pone.0128032. eCollection 2015.
PubMed 26010450Yuan F, Peng W, Yang C, Zheng J. Teriparatide versus bisphosphonates for treatment of postmenopausal osteoporosis: A meta-analysis. Int J Surg. 2019 Jun;66:1-11. doi: 10.1016/j.ijsu.2019.03.004. Epub 2019 Mar 16.
PubMed 30890377
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resolution of Hyperparathyroidism With High-dose Vitamin D Improves Osteoporosis in Multi-treated Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05347082
- Acronym / sponsor ID
- 120.2021
- Conditions
- Postmenopausal Osteoporosis, Postmenopause, Hyperparathyroidism, Secondary, Hypovitaminosis D, Hyperparathyroidism, Primary
- Keywords
- Vitamin D, Postmenopause, Osteopenia, Osteoporosis, Bone Mineral Density, Hyperparathyroidism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hospital Regional 1o de OctubreUniversity, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, National Polytechnic Institute, Mexico
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 26 Apr 2022 (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.
Recently, an increase in the prevalence of hyperparathyroidism and hypovitaminosis D in postmenopause women has been occurring in Mexico and the world. Chronic exposure to the parathyroid hormone (PTH) is catabolic for the bone, worsening the state of osteoporosis. However, it is unclear whether these conditions could significantly improve bone mineral density (BMD). In the present work, it was shown that the resolution of hyperparathyroidism in postmenopausal women improves osteoporosis.
Detailed description
This study was an open clinical trial conducted in Mexican women diagnosed with postmenopausal osteoporosis and hyperparathyroidism associated or not with hypovitaminosis D from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE).
An integral clinical evaluation with PTH and vitamin D measurement was first done to determine the frequency of primary hyperparathyroidism and hypovitaminosis D. Likewise, a thyroid ultrasound was done. Then, 8000 IU of vitamin D were orally administrated for four weeks. Statical analysis was performed using PAST 3.0 and GraphPad Prism 8.4.3. software. The arithmetic median (µ) and standard deviation (S.D.) were calculated using Excel-Word. Graphics were constructed with GraphPad Prism 8.4.3 and tables with Excel-Word. Categorical variables were analysed with chi-squared or Fisher exact test depending on the number of participants in each cell. Normality was determined using the Shapiro-Wilk test. To compare two paired samples, the Wilcoxon signed-rank test was utilized. To perform correlations, the Spearman correlation coefficient was used. The assigned α value for this study was <0.05. In all cases, if a Montecarlo permutation was available, the exact p-value was taken instead of the raw p-value.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 47 participants who met the inclusion criteria were included and all received 8000 IU of vitamin D orally for four weeks.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Cholecalciferol8000 IU of vitamin D orally, once a day, for four weeks. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Acceptance to participate in the study with informed consent.
- Postmenopausal osteoporosis or osteopenia.
- Primary or secondary hyperparathyroidism.
- Insufficiency or deficiency of vitamin D.
- Multi-treated postmenopausal osteoporosis.
Key exclusion criteria (5 listed)
- Different osteoporosis aetiology not related to oestrogenic deficiency.
- Thyroid pathology.
- Previous treatment with vitamin D, thiazide diuretics, lithium, Teriparatide or glucocorticoids.
- Known allergies to vitamin D.
- Addison's disease, pheochromocytoma, and depressive disorders.
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 |
|---|---|---|
| CholecalciferolAlso: Histofil®Tablets of 4000 IU | Drug | Vitamin D |
Primary outcome
Number of Participants with Remission of Hyperparathyroidism
Time frame: 4 weeks
Clinical remission of hyperparathyroidism was evaluated after treatment.
Number of Participants with Remission of Hypovitaminosis D
Time frame: 4 weeks.
Clinical remission of vitamin D deficiency or insufficiency were evaluated after treatment.
Change from baseline hip T score at 4 weeks
Time frame: 4 weeks
Osteoporosis in the hip was determined by a T score greater than -2.5 and osteopenia was determined by a T score between -1 to -2.4.
Change from baseline lumbar spine T score at 4 weeks
Time frame: 4 weeks
Osteoporosis in the lumbar spine was determined by a T-score greater than -2.5 and osteopenia was determined by a T-score between -1 and -2.4.
1 secondary outcome
Change from baseline general T score at 4 weeks
Time frame: 4 weeks
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 6 May 2022.
- Background: PubMed 25182228Cosman F, de Beur SJ, LeBoff MS, Lewiecki EM, Tanner B, Randall S, Lindsay R; National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014 Oct;25(10):2359-81. doi: 10.1007/s00198-014-2794-2. Epub 2014 Aug 15.
- Background: PubMed 12045863Lundgren E, Hagstrom EG, Lundin J, Winnerback K, Roos J, Ljunghall S, Rastad J. Primary hyperparathyroidism revisited in menopausal women with serum calcium in the upper normal range at population-based screening 8 years ago. World J Surg. 2002 Aug;26(8):931-6. doi: 10.1007/s00268-002-6621-0. Epub 2002 Jun 6.
- Background: PubMed 15644400Grey A, Lucas J, Horne A, Gamble G, Davidson JS, Reid IR. Vitamin D repletion in patients with primary hyperparathyroidism and coexistent vitamin D insufficiency. J Clin Endocrinol Metab. 2005 Apr;90(4):2122-6. doi: 10.1210/jc.2004-1772. Epub 2005 Jan 11.
- Background: PubMed 19383807Tucci JR. Vitamin D therapy in patients with primary hyperparathyroidism and hypovitaminosis D. Eur J Endocrinol. 2009 Jul;161(1):189-93. doi: 10.1530/EJE-08-0901. Epub 2009 Apr 21.
- Background: PubMed 29267648Contreras-Manzano A, Villalpando S, Robledo-Perez R. Vitamin D status by sociodemographic factors and body mass index in Mexican women at reproductive age. Salud Publica Mex. 2017 Sep-Oct;59(5):518-525. doi: 10.21149/8080.
- Background: PubMed 29435763Goltzman D. Functions of vitamin D in bone. Histochem Cell Biol. 2018 Apr;149(4):305-312. doi: 10.1007/s00418-018-1648-y. Epub 2018 Feb 12.
- Background: PubMed 21872800Lips P, van Schoor NM. The effect of vitamin D on bone and osteoporosis. Best Pract Res Clin Endocrinol Metab. 2011 Aug;25(4):585-91. doi: 10.1016/j.beem.2011.05.002.
- Background: PubMed 11493580Lips P. Vitamin D deficiency and secondary hyperparathyroidism in the elderly: consequences for bone loss and fractures and therapeutic implications. Endocr Rev. 2001 Aug;22(4):477-501. doi: 10.1210/edrv.22.4.0437.
- Background: PubMed 17182297Recker RR, Kendler D, Recknor CP, Rooney TW, Lewiecki EM, Utian WH, Cauley JA, Lorraine J, Qu Y, Kulkarni PM, Gaich CL, Wong M, Plouffe L Jr, Stock JL. Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass. Bone. 2007 Apr;40(4):843-51. doi: 10.1016/j.bone.2006.11.001. Epub 2006 Dec 19.
- Background: PubMed 12904517Manson JE, Hsia J, Johnson KC, Rossouw JE, Assaf AR, Lasser NL, Trevisan M, Black HR, Heckbert SR, Detrano R, Strickland OL, Wong ND, Crouse JR, Stein E, Cushman M; Women's Health Initiative Investigators. Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med. 2003 Aug 7;349(6):523-34. doi: 10.1056/NEJMoa030808.
- Background: PubMed 17598097Watson J, Wise L, Green J. Prescribing of hormone therapy for menopause, tibolone, and bisphosphonates in women in the UK between 1991 and 2005. Eur J Clin Pharmacol. 2007 Sep;63(9):843-9. doi: 10.1007/s00228-007-0320-6. Epub 2007 Jun 28.
- Background: PubMed 27801641Davis S, Martyn-St James M, Sanderson J, Stevens J, Goka E, Rawdin A, Sadler S, Wong R, Campbell F, Stevenson M, Strong M, Selby P, Gittoes N. A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures. Health Technol Assess. 2016 Oct;20(78):1-406. doi: 10.3310/hta20780.
- Individual participant dataSharing planned: No
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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.
Juan M Ocampo Godínez, M.D., Ph.D. study director
Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]
Patricia Loranca-Moreno, M.D., M.Sc. study director
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
Paula M Sánchez-Tinoco, M.D. principal investigator
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Postmenopausal Osteoporosis and Postmenopause, run by Hospital Regional 1o de Octubre at 1 site in Mexico.
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 6 inclusion and 5 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 6 May 2022. 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 Mexico. 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?
Number of Participants with Remission of Hyperparathyroidism (time frame: 4 weeks). The study lists 4 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 NCT05347082, which also lists 23 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 6 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.