OsteoporosisPhase 4NCT06938152
Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients
A Phase 4 study testing Romosozumab followed by Denosumab and Romosozumab and Denosumab Cycle Therapy in people with Osteoporosis and Osteoporosis Postmenopausal, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study is a prospective, randomized, controlled clinical trial comparing the efficacy of a 24-month cyclic therapy regimen (6 months of Romosozumab followed by 6 months of Denosumab, repeated for two years) versus a traditional sequential treatment regimen (12 months of Romosozumab followed by 12 months of… Read more about this study
- Who is it for?
- Ages 50 to 90 years, women only
- Conditions the study is for
- Osteoporosis, Osteoporosis Postmenopausal
- What is being tested?
- Romosozumab followed by Denosumab and Romosozumab and Denosumab Cycle Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2025to 31 Dec 2029
- Phase
- Phase 4
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Postmenopausal women aged 50-90 years
- 2. BMD T-score ≤ -3.0 at any lumbar vertebra
- 3. Physically and mentally capable of understanding and complying with the study protocol and follow-up
- 4. Signed informed consent
Who cannot join
- 1. Previous osteoporosis treatment within the past two years, including Romosozumab, Teriparatide, Denosumab, Alendronate, Ibandronate, Zoledronic Acid, Risedronate, Raloxifene, or Bazedoxifene
- 2. Allergy to Romosozumab or Denosumab
- 3. Secondary osteoporosis
- 4. Autoimmune disease
- 5. Chronic steroid use (e.g., Chronic Obstruction Pulmonary Disease patients)
- 6. Hypercalcemia or hypocalcemia
Show all 13Show fewer
- 7. Metabolic bone diseases
- 8. Primary or metastatic bone tumors
- 9. Cancer patients (except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years)
- 10. Planned dental procedures (e.g., extractions, implants) within the next year
- 11. History of stent placement, myocardial infarction, stroke, or coronary artery disease
- 12. Renal disease (Creatinine > 1.5 mg/dL) or dialysis patients
- 13. Smoking more than one pack per day (except for those who have quit for over ten years)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Fon-Yih Tsuang, +886-2312-3456 ext. 265956, k880113a@gmail.com
About this study
Official title: Effects of Cycle Therapy With Romosozumab and Denosumab 2 Years vs 1 Year Romosozumab Followed by 1 Year Denosumab in Postmenopausal Osteoporosis Patients-A Randomized Control Trial
This study is a prospective, randomized, controlled clinical trial comparing the efficacy of a 24-month cyclic therapy regimen (6 months of Romosozumab followed by 6 months of Denosumab, repeated for two years) versus a traditional sequential treatment regimen (12 months of Romosozumab followed by 12 months of Denosumab). The goal is to determine which approach yields better therapeutic outcomes and to optimize drug strategies for osteoporosis patients.
Read the detailed description
Osteoporosis is common in postmenopausal women and the elderly, and has been recognized by the World Health Organization as the second most prevalent metabolic bone disease worldwide. Most patients show no obvious symptoms, but a fall or sudden exertion can cause fragility fractures. Once fractures occur, complications such as acute pain, prolonged bed rest, and restricted mobility can significantly impact the quality of life and even increase mortality. Furthermore, managing these conditions requires substantial medical and social resources.
Currently, anti-osteoporosis medications are classified into two major categories: antiresorptive and anabolic agents. Studies have confirmed that both types can increase bone mineral density (BMD) and reduce fracture risk. However, each medication has usage limitations.
Denosumab is a potent antiresorptive drug, but long-term use can lead to rare side effects such as atypical femoral fractures (AFF) and medication-related osteonecrosis of the jaw (MRONJ). Additionally, stopping Denosumab can cause a severe rebound in bone resorption markers (CTX), leading to rapid BMD loss and an increased fracture risk. Managing drug discontinuation remains a major clinical challenge.
- Conditions
- Osteoporosis, Osteoporosis Postmenopausal
- Being tested
- Romosozumab followed by Denosumab, Romosozumab and Denosumab Cycle Therapy
- Keywords
- postmenopausal, Romosozumab, Denosumab, cycle therapy, Bone mineral density, Bone turnover marker
- Medical subject headings
- Osteoporosis, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Romosozumab followed by DenosumabDrug
Also called Sequential therapy group
Romosozumab 210mg/month for 12 months, then Denosumab 60mg/6months for 12 months
Romosozumab and Denosumab Cycle TherapyDrug
Also called Cycle therapy group
Romosozumab 210mg/month for 6 months then followed by Denosumab 60mg/6months once, and then repeat one more time after 6 months
| Study group | Role | What they receive |
|---|---|---|
| Sequential therapy group | Active comparator | Romosozumab followed by Denosumab Receives: Drug: Romosozumab followed by Denosumab |
| Cycle therapy group | Experimental | Romosozumab and Denosumab Cycle Therapy Receives: Drug: Romosozumab and Denosumab Cycle Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone mineral density (BMD)
Change in BMD at lumbar spine, femoral neck and total hip at 24 months
Measured: Participants will undergo baseline assessments, followed by evaluations at 6, 12, 18 and 24 months.
Secondary outcomes (5)
Change in bone turnover makers (BTM) level
Changes in BTM, including bone formation (P1NP) and resorption markers (CTX)
Measured: Participants will undergo baseline assessments, followed by evaluations at 3, 6, 9, 12, 13, 15, 18, 21, and 24 months.
Change in visual Analogue Scale (VAS) score
The Visual Analogue Scale (VAS) for pain will be used to assess participants' self-reported pain intensity. The VAS score ranges from 0 to 10, higher scores indicate worse pain intensity, and lower scores indicate less pain.
Measured: Participants will undergo baseline assessments, followed by evaluations at 3, 6, 9, 12, 15, 18, 21, and 24 months.
Oswestry Disability Index (ODI) score change
The Oswestry Disability Index (ODI) will be used to assess the level of disability related to lower back pain. The ODI score ranges from 0 to 100, higher scores reflect worse functional disability and lower scores reflect better functional status.
Measured: Participants will undergo baseline assessments, followed by evaluations at 6, 12, 18 and 24 months.
New fracture
Any new fracture within 24 months
Measured: During the intervention period, up to 24 months.
Adverse Events
Any adverse events
Measured: During the intervention period, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start8 Apr 2025
- Primary completion30 Apr 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938152
- Sponsor's protocol ID
- 202501144MINE
- Status last verified
- Jun 2026
- First submitted
- 6 Apr 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kobayakawa T, Miyazaki A, Takahashi J, Nakamura Y. Verification of efficacy and safety of ibandronate or denosumab for postmenopausal osteoporosis after 12-month treatment with romosozumab as sequential therapy: The prospective VICTOR study. Bone. 2022 Sep;162:116480. doi: 10.1016/j.bone.2022.116480. Epub 2022 Jul 1.
PubMed 35787482Hong N, Shin S, Kim H, Cho SJ, Park JA, Rhee Y. Romosozumab following denosumab improves lumbar spine bone mineral density and trabecular bone score greater than denosumab continuation in postmenopausal women. J Bone Miner Res. 2025 Feb 2;40(2):184-192. doi: 10.1093/jbmr/zjae179.
PubMed 39485918Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 Oct 20;375(16):1532-1543. doi: 10.1056/NEJMoa1607948. Epub 2016 Sep 18.
PubMed 27641143Chandran M. The why and how of sequential and combination therapy in osteoporosis. A review of the current evidence. Arch Endocrinol Metab. 2022 Nov 11;66(5):724-738. doi: 10.20945/2359-3997000000564.
PubMed 36382762Gehrke B, Alves Coelho MC, Brasil d'Alva C, Madeira M. Long-term consequences of osteoporosis therapy with bisphosphonates. Arch Endocrinol Metab. 2023 Nov 10;68:e220334. doi: 10.20945/2359-4292-2022-0334.
PubMed 37948565McClung MR, Wagman RB, Miller PD, Wang A, Lewiecki EM. Observations following discontinuation of long-term denosumab therapy. Osteoporos Int. 2017 May;28(5):1723-1732. doi: 10.1007/s00198-017-3919-1. Epub 2017 Jan 31.
PubMed 28144701Cosman F, Huang S, McDermott M, Cummings SR. Multiple Vertebral Fractures After Denosumab Discontinuation: FREEDOM and FREEDOM Extension Trials Additional Post Hoc Analyses. J Bone Miner Res. 2022 Nov;37(11):2112-2120. doi: 10.1002/jbmr.4705. Epub 2022 Oct 12.
PubMed 36088628Reid IR, Billington EO. Drug therapy for osteoporosis in older adults. Lancet. 2022 Mar 12;399(10329):1080-1092. doi: 10.1016/S0140-6736(21)02646-5.
PubMed 35279261LeBoff MS, Greenspan SL, Insogna KL, Lewiecki EM, Saag KG, Singer AJ, Siris ES. The clinician's guide to prevention and treatment of osteoporosis. Osteoporos Int. 2022 Oct;33(10):2049-2102. doi: 10.1007/s00198-021-05900-y. Epub 2022 Apr 28.
PubMed 35478046Fogelman I, Blake GM. Different approaches to bone densitometry. J Nucl Med. 2000 Dec;41(12):2015-25.
PubMed 11138687Wang CY, Wu CH, Chen HM, Lin JW, Hsu CC, Chang YF, Tai TW, Fu SH, Hwang JS. Cost and effectiveness analyses of the anti-osteoporosis medication in patients with hip fracture in Taiwan: A population-based national claims database analysis. J Formos Med Assoc. 2023;122 Suppl 1:S92-S100. doi: 10.1016/j.jfma.2023.07.018. Epub 2023 Aug 11.
PubMed 37574339Wang CY, Fu SH, Yang RS, Shen LJ, Wu FL, Hsiao FY. Age- and gender-specific epidemiology, treatment patterns, and economic burden of osteoporosis and associated fracture in Taiwan between 2009 and 2013. Arch Osteoporos. 2017 Oct 25;12(1):92. doi: 10.1007/s11657-017-0385-5.
PubMed 29067572
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cycle Therapy With Romosozumab and Denosumab 2 Years vs 1 Year Romosozumab Followed by 1 Year Denosumab in Postmenopausal Osteoporosis Patients-A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06938152
- Acronym / sponsor ID
- 202501144MINE
- Conditions
- Osteoporosis, Osteoporosis Postmenopausal
- Keywords
- postmenopausal, Romosozumab, Denosumab, cycle therapy, Bone mineral density, Bone turnover marker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Apr 2025 (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.
This study is a prospective, randomized, controlled clinical trial comparing the efficacy of a 24-month cyclic therapy regimen (6 months of Romosozumab followed by 6 months of Denosumab, repeated for two years) versus a traditional sequential treatment regimen (12 months of Romosozumab followed by 12 months of Denosumab). The goal is to determine which approach yields better therapeutic outcomes and to optimize drug strategies for osteoporosis patients.
Detailed description
Osteoporosis is common in postmenopausal women and the elderly, and has been recognized by the World Health Organization as the second most prevalent metabolic bone disease worldwide. Most patients show no obvious symptoms, but a fall or sudden exertion can cause fragility fractures. Once fractures occur, complications such as acute pain, prolonged bed rest, and restricted mobility can significantly impact the quality of life and even increase mortality. Furthermore, managing these conditions requires substantial medical and social resources.
Currently, anti-osteoporosis medications are classified into two major categories: antiresorptive and anabolic agents. Studies have confirmed that both types can increase bone mineral density (BMD) and reduce fracture risk. However, each medication has usage limitations.
Denosumab is a potent antiresorptive drug, but long-term use can lead to rare side effects such as atypical femoral fractures (AFF) and medication-related osteonecrosis of the jaw (MRONJ). Additionally, stopping Denosumab can cause a severe rebound in bone resorption markers (CTX), leading to rapid BMD loss and an increased fracture risk. Managing drug discontinuation remains a major clinical challenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential therapy group | Active comparator | Drug: Romosozumab followed by DenosumabRomosozumab followed by Denosumab |
| Cycle therapy group | Experimental | Drug: Romosozumab and Denosumab Cycle TherapyRomosozumab and Denosumab Cycle Therapy |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Postmenopausal women aged 50-90 years
- 2. BMD T-score ≤ -3.0 at any lumbar vertebra
- 3. Physically and mentally capable of understanding and complying with the study protocol and follow-up
- 4. Signed informed consent
Key exclusion criteria (13 listed)
- 1. Previous osteoporosis treatment within the past two years, including Romosozumab, Teriparatide, Denosumab, Alendronate, Ibandronate, Zoledronic Acid, Risedronate, Raloxifene, or Bazedoxifene
- 2. Allergy to Romosozumab or Denosumab
- 3. Secondary osteoporosis
- 4. Autoimmune disease
- 5. Chronic steroid use (e.g., Chronic Obstruction Pulmonary Disease patients)
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 |
|---|---|---|
| Romosozumab followed by DenosumabAlso: Sequential therapy groupRomosozumab 210mg/month for 12 months, then Denosumab 60mg/6months for 12 months | Drug | Sequential therapy group |
| Romosozumab and Denosumab Cycle TherapyAlso: Cycle therapy groupRomosozumab 210mg/month for 6 months then followed by Denosumab 60mg/6months once, and then repeat one more time after 6 months | Drug | Cycle therapy group |
Primary outcome
Change in bone mineral density (BMD)
Time frame: Participants will undergo baseline assessments, followed by evaluations at 6, 12, 18 and 24 months.
Change in BMD at lumbar spine, femoral neck and total hip at 24 months
5 secondary outcomes
Change in bone turnover makers (BTM) level
Time frame: Participants will undergo baseline assessments, followed by evaluations at 3, 6, 9, 12, 13, 15, 18, 21, and 24 months.
Change in visual Analogue Scale (VAS) score
Time frame: Participants will undergo baseline assessments, followed by evaluations at 3, 6, 9, 12, 15, 18, 21, and 24 months.
Oswestry Disability Index (ODI) score change
Time frame: Participants will undergo baseline assessments, followed by evaluations at 6, 12, 18 and 24 months.
New fracture
Time frame: During the intervention period, up to 24 months.
Adverse Events
Time frame: During the intervention period, up to 24 months.
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 23 Jun 2026.
- Results publication: PubMed 35787482Kobayakawa T, Miyazaki A, Takahashi J, Nakamura Y. Verification of efficacy and safety of ibandronate or denosumab for postmenopausal osteoporosis after 12-month treatment with romosozumab as sequential therapy: The prospective VICTOR study. Bone. 2022 Sep;162:116480. doi: 10.1016/j.bone.2022.116480. Epub 2022 Jul 1.
- Results publication: PubMed 39485918Hong N, Shin S, Kim H, Cho SJ, Park JA, Rhee Y. Romosozumab following denosumab improves lumbar spine bone mineral density and trabecular bone score greater than denosumab continuation in postmenopausal women. J Bone Miner Res. 2025 Feb 2;40(2):184-192. doi: 10.1093/jbmr/zjae179.
- Results publication: PubMed 27641143Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 Oct 20;375(16):1532-1543. doi: 10.1056/NEJMoa1607948. Epub 2016 Sep 18.
- Results publication: PubMed 36382762Chandran M. The why and how of sequential and combination therapy in osteoporosis. A review of the current evidence. Arch Endocrinol Metab. 2022 Nov 11;66(5):724-738. doi: 10.20945/2359-3997000000564.
- Results publication: PubMed 37948565Gehrke B, Alves Coelho MC, Brasil d'Alva C, Madeira M. Long-term consequences of osteoporosis therapy with bisphosphonates. Arch Endocrinol Metab. 2023 Nov 10;68:e220334. doi: 10.20945/2359-4292-2022-0334.
- Results publication: PubMed 28144701McClung MR, Wagman RB, Miller PD, Wang A, Lewiecki EM. Observations following discontinuation of long-term denosumab therapy. Osteoporos Int. 2017 May;28(5):1723-1732. doi: 10.1007/s00198-017-3919-1. Epub 2017 Jan 31.
- Results publication: PubMed 36088628Cosman F, Huang S, McDermott M, Cummings SR. Multiple Vertebral Fractures After Denosumab Discontinuation: FREEDOM and FREEDOM Extension Trials Additional Post Hoc Analyses. J Bone Miner Res. 2022 Nov;37(11):2112-2120. doi: 10.1002/jbmr.4705. Epub 2022 Oct 12.
- Results publication: PubMed 35279261Reid IR, Billington EO. Drug therapy for osteoporosis in older adults. Lancet. 2022 Mar 12;399(10329):1080-1092. doi: 10.1016/S0140-6736(21)02646-5.
- Results publication: PubMed 35478046LeBoff MS, Greenspan SL, Insogna KL, Lewiecki EM, Saag KG, Singer AJ, Siris ES. The clinician's guide to prevention and treatment of osteoporosis. Osteoporos Int. 2022 Oct;33(10):2049-2102. doi: 10.1007/s00198-021-05900-y. Epub 2022 Apr 28.
- Results publication: PubMed 11138687Fogelman I, Blake GM. Different approaches to bone densitometry. J Nucl Med. 2000 Dec;41(12):2015-25.
- Results publication: PubMed 37574339Wang CY, Wu CH, Chen HM, Lin JW, Hsu CC, Chang YF, Tai TW, Fu SH, Hwang JS. Cost and effectiveness analyses of the anti-osteoporosis medication in patients with hip fracture in Taiwan: A population-based national claims database analysis. J Formos Med Assoc. 2023;122 Suppl 1:S92-S100. doi: 10.1016/j.jfma.2023.07.018. Epub 2023 Aug 11.
- Results publication: PubMed 29067572Wang CY, Fu SH, Yang RS, Shen LJ, Wu FL, Hsiao FY. Age- and gender-specific epidemiology, treatment patterns, and economic burden of osteoporosis and associated fracture in Taiwan between 2009 and 2013. Arch Osteoporos. 2017 Oct 25;12(1):92. doi: 10.1007/s11657-017-0385-5.
- National Institute of Arthritis and Musculoskeletal and Skin Diseases. (2022.12)Link provided by the sponsor.
- 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 4 study testing Romosozumab followed by Denosumab and Romosozumab and Denosumab Cycle Therapy in people with Osteoporosis and Osteoporosis Postmenopausal, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 13 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 23 Jun 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Fon-Yih Tsuang (886-2312-3456 ext. 265956, k880113a@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone mineral density (BMD) (time frame: Participants will undergo baseline assessments, followed by evaluations at 6, 12, 18 and 24 months.). 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 NCT06938152, which also lists 12 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 23 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.