Postmenopausal OsteoporosisPhase 2PMOPNCT02854722
The Deferasirox-calcium-vitamin D3 Therapy for Postmenopausal Osteoporosis (PMOP)
A Phase 2 study testing Deferasirox and calcium-vitamin D3 and Calcium-vitamin D3 in people with Postmenopausal Osteoporosis, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
In 2006, Weinberg proposed a hypothesis that iron accumulation was a risk factor for osteoporosis. Osteoporosis is a common complication in various diseases, such as hemochromatosis, African hemosiderosis, thalassemia, and sickle cell disease, which all share iron accumulation as a common denominator. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Deferasirox and calcium-vitamin D3 and Calcium-vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2018to 15 Jun 2020
- Phase
- Phase 2
- 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Lumbar spine or hip BMD T-score ≤-2.5 SD.
- Elevated serum ferritin (females: serum 500ng/ml≤ferritin≤1000ng/ml).
Who cannot join
- Anemia < 10 g/dl
- Serum liver enzymes or bilirubin above the upper limit of normal at screening.
- Patients with creatinine clearance <60 ml/min will be excluded.
- Known allergy or contraindication to the administration of Deferasirox.
- History of blood transfusion during the 6 months prior to study entry.
- Oral iron supplementation within the last 4 weeks of study entry.
Show all 11Show fewer
- Treatment with phlebotomy within 2 weeks of screening visit.
- Patient is already taking deferasirox therapy for any reason at the time of screening.
- Patients currently or previously treated with deferiprone or Deferasirox.
- Patients with active inflammatory diseases that may interfere with the accurate measurement of serum ferritin.
- Patients with a diagnosis of a clinically relevant cataract or a previous history of clinically relevant ocular toxicity related to iron chelation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Youjia Xu, Ph.D,M.D., +86 512 67783346, xuyoujia@medmail.com.cn
You-Jia Xu, Ph.D,M.D.
About this study
Official title: Phase 2 Study of Deferasirox-calcium-vitamin D3 to Treat Postmenopausal Osteoporosis (PMOP)
In 2006, Weinberg proposed a hypothesis that iron accumulation was a risk factor for osteoporosis. Osteoporosis is a common complication in various diseases, such as hemochromatosis, African hemosiderosis, thalassemia, and sickle cell disease, which all share iron accumulation as a common denominator. Moreover, a 3-year retrospective longitudinal study has shown that iron accumulation was also associated with osteoporosis in healthy adults and especially that it can increase the risk of fractures in postmenopausal women. Based on these observations, iron chelation therapy may have a promising future in the treatment of iron accumulation-related osteoporosis by removing iron from the body.
The purpose of this study is to determine whether the addition of the iron chelator, deferasirox, to standard therapy for postmenopausal osteoporosis, is safe and effective.
Read the detailed description
Postmenopausal osteoporosis (PMOP) is a systemic bone metabolism disease, characterized by progressive bone loss following menopause and a subsequent increase in fracture risk. Estrogen deficiency as a result of menopause is known to increase bone resorption and accelerate bone loss. Furthermore, postmenopausal women may exhibit iron accumulation, in addition to estrogen deficiency. Elevated iron levels are a risk factor for PMOP in postmenopausal women, and reducing the iron overload by iron chelators has been demonstrated to benefit bone cell metabolism in vitro and improve the bone in vivo by normalizing osteoclastic bone resorption and formation.
Although the safety and efficacy of deferasirox have been evaluated in iron-overloaded patients extensively, there are no data in iron-accumulated postmenopausal women, let alone in iron-accumulated postmenopausal women with osteoporosis. Therefore, at the currently planned dose, confirming safety and efficacy is essential in the current study to lay the groundwork for a future phase III clinical trial.
This is a prospective, phase II, randomized, open label, placebo-controlled study of calcium-vitamin D3 plus deferasirox vs. calcium-vitamin D3 for postmenopausal osteoporosis. Ten postmenopausal women diagnosed with osteoporosis by DXA, who were accompanied by iron accumulation (serum 500ng/ml≤ferritin≤1000ng/ml), will be randomized to receive calcium-vitamin D3 plus deferasirox or calcium-vitamin D3 (n = 5 per arm).
The primary objective is to determine the safety and tolerability of adjunctive deferasirox therapy in postmenopausal women being treated with calcium-vitamin D3 for osteoporosis, and to obtain exploratory data on the efficacy of the iron chelation treatment. The reduction in iron levels with deferasirox may provide a viable therapeutic option for mitigating the iron accumulation associated with PMOP.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Deferasirox and calcium-vitamin D3, Calcium-vitamin D3
- Keywords
- deferasirox, iron accumulation
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferasirox and calcium-vitamin D3Drug
deferasirox and calcium-vitamin D3 Deferasirox is an orodispersible tablet and should be taken daily 30 minutes before breakfast, with a dose of 10 mg/Kg/day ± 5 mg/Kg/day during 12 month.
Calcium 500 mg and vitamin D3 800 IU should also be taken daily as a basic therapy.
Calcium-vitamin D3Drug
Calcium 500 mg and vitamin D3 800 IU are taken daily as a basic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Deferasirox and calcium-vitamin D3 | Experimental | Deferasirox is an orodispersible tablet and should be taken daily 30 minutes before breakfast, with a dose of 10 mg/Kg/day ± 5 mg/Kg/day during 12 month.
Calcium 500 mg and Vitamin D3 800 IU should also be taken daily as a basic therapy. Receives: Drug: Deferasirox and calcium-vitamin D3; Drug: Calcium-vitamin D3 |
| Calcium-vitamin D3 | Placebo comparator | Calcium 500 mg and Vitamin D3 800 IU are taken daily as a basic therapy. Receives: Drug: Calcium-vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
An adverse event was any untoward medical occurrence in participants, and did not necessarily need to have a causal relationship with the drug in the trial. The relationship of each adverse event to study drug or the severity of each adverse event was judged by the investigator, as described below. A serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions:
fatal or life-threatening; requires inpatient hospitalization; persistent or significant disability/incapacity;
Measured: 12 months
Number of participants with abnormal blood pressure, heart rate, body temperature, and/or physical examination that are related to the treatment
Measured: 12 months
Bone mineral density
Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. Percent changes in DXA Bone Mineral Density from baseline to month 6 and month 12 of the trial in all patients. Percent change from Baseline was calculated as (BMD at Month 6 or Month 12 - BMD at Baseline)/BMD at Baseline * 100%.
Measured: Baseline, Month 6, Month 12
Secondary outcomes (5)
Change from baseline in serum C-terminal telopeptide of type I collagen (β-CTX)
Measured: Baseline, Month 3, Month 6, Month 9 and Month 12
Change from baseline in serum N-aminoterminal prepeptide of type I procollagen (P1NP)
Measured: Baseline, Month 3, Month 6, Month 9 and Month 12
Change from baseline in serum ferritin
Measured: Baseline, Month 3, Month 6, Month 9 and Month 12
Change from baseline in blood chemistry
Measured: Baseline, Week 2, Week 4 and Month 3, Month 6, Month 9, Month 12 of the trial
Change from baseline in hematology
Measured: Baseline, Week 2, Week 4 and Month 3, Month 6, Month 9, Month 12 of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start15 Jan 2018
- Primary completion15 Jun 2019 (estimated)
- Study completion15 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, You-Jia Xu, Second Affiliated Hospital of Soochow University
- Investigators
- You-Jia Xu, Ph.D,M.D., Principal investigator, Second Afflilated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854722
- Sponsor's protocol ID
- BL2014044
- Acronym
- PMOP
- Status last verified
- May 2018
- First submitted
- 19 Jul 2016
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim BJ, Ahn SH, Bae SJ, Kim EH, Lee SH, Kim HK, Choe JW, Koh JM, Kim GS. Iron overload accelerates bone loss in healthy postmenopausal women and middle-aged men: a 3-year retrospective longitudinal study. J Bone Miner Res. 2012 Nov;27(11):2279-90. doi: 10.1002/jbmr.1692.
PubMed 22729843Mitchell F. Bone: high body iron stores lead to bone loss. Nat Rev Endocrinol. 2012 Sep;8(9):506. doi: 10.1038/nrendo.2012.127. Epub 2012 Jul 17. No abstract available.
PubMed 22801718Li GF, Pan YZ, Sirois P, Li K, Xu YJ. Iron homeostasis in osteoporosis and its clinical implications. Osteoporos Int. 2012 Oct;23(10):2403-8. doi: 10.1007/s00198-012-1982-1. Epub 2012 Apr 14.
PubMed 22525981Huang X, Xu Y, Partridge NC. Dancing with sex hormones, could iron contribute to the gender difference in osteoporosis? Bone. 2013 Aug;55(2):458-60. doi: 10.1016/j.bone.2013.03.008. Epub 2013 Mar 22. No abstract available.
PubMed 23523718Chen B, Yan YL, Liu C, Bo L, Li GF, Wang H, Xu YJ. Therapeutic effect of deferoxamine on iron overload-induced inhibition of osteogenesis in a zebrafish model. Calcif Tissue Int. 2014 Mar;94(3):353-60. doi: 10.1007/s00223-013-9817-4. Epub 2014 Jan 12.
PubMed 24414856Chen B, Li GF, Shen Y, Huang XI, Xu YJ. Reducing iron accumulation: A potential approach for the prevention and treatment of postmenopausal osteoporosis. Exp Ther Med. 2015 Jul;10(1):7-11. doi: 10.3892/etm.2015.2484. Epub 2015 May 8.
PubMed 26170904Shen GS, Yang Q, Jian JL, Zhao GY, Liu LL, Wang X, Zhang W, Huang X, Xu YJ. Hepcidin1 knockout mice display defects in bone microarchitecture and changes of bone formation markers. Calcif Tissue Int. 2014 Jun;94(6):632-9. doi: 10.1007/s00223-014-9845-8. Epub 2014 Mar 21.
PubMed 24652331Xu Y, Li G, Du B, Zhang P, Xiao L, Sirois P, Li K. Hepcidin increases intracellular Ca2+ of osteoblast hFOB1.19 through L-type Ca2+ channels. Regul Pept. 2011 Dec 10;172(1-3):58-61. doi: 10.1016/j.regpep.2011.08.009. Epub 2011 Sep 10.
PubMed 21911012Jia P, Xu YJ, Zhang ZL, Li K, Li B, Zhang W, Yang H. Ferric ion could facilitate osteoclast differentiation and bone resorption through the production of reactive oxygen species. J Orthop Res. 2012 Nov;30(11):1843-52. doi: 10.1002/jor.22133. Epub 2012 May 8.
PubMed 22570238
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Deferasirox-calcium-vitamin D3 to Treat Postmenopausal Osteoporosis (PMOP)
- ClinicalTrials.gov ID
- NCT02854722
- Acronym / sponsor ID
- PMOP / BL2014044
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- deferasirox, iron accumulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 15 Jun 2020 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- 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.
In 2006, Weinberg proposed a hypothesis that iron accumulation was a risk factor for osteoporosis. Osteoporosis is a common complication in various diseases, such as hemochromatosis, African hemosiderosis, thalassemia, and sickle cell disease, which all share iron accumulation as a common denominator. Moreover, a 3-year retrospective longitudinal study has shown that iron accumulation was also associated with osteoporosis in healthy adults and especially that it can increase the risk of fractures in postmenopausal women. Based on these observations, iron chelation therapy may have a promising future in the treatment of iron accumulation-related osteoporosis by removing iron from the body.
The purpose of this study is to determine whether the addition of the iron chelator, deferasirox, to standard therapy for postmenopausal osteoporosis, is safe and effective.
Detailed description
Postmenopausal osteoporosis (PMOP) is a systemic bone metabolism disease, characterized by progressive bone loss following menopause and a subsequent increase in fracture risk. Estrogen deficiency as a result of menopause is known to increase bone resorption and accelerate bone loss. Furthermore, postmenopausal women may exhibit iron accumulation, in addition to estrogen deficiency. Elevated iron levels are a risk factor for PMOP in postmenopausal women, and reducing the iron overload by iron chelators has been demonstrated to benefit bone cell metabolism in vitro and improve the bone in vivo by normalizing osteoclastic bone resorption and formation.
Although the safety and efficacy of deferasirox have been evaluated in iron-overloaded patients extensively, there are no data in iron-accumulated postmenopausal women, let alone in iron-accumulated postmenopausal women with osteoporosis. Therefore, at the currently planned dose, confirming safety and efficacy is essential in the current study to lay the groundwork for a future phase III clinical trial.
This is a prospective, phase II, randomized, open label, placebo-controlled study of calcium-vitamin D3 plus deferasirox vs. calcium-vitamin D3 for postmenopausal osteoporosis. Ten postmenopausal women diagnosed with osteoporosis by DXA, who were accompanied by iron accumulation (serum 500ng/ml≤ferritin≤1000ng/ml), will be randomized to receive calcium-vitamin D3 plus deferasirox or calcium-vitamin D3 (n = 5 per arm).
The primary objective is to determine the safety and tolerability of adjunctive deferasirox therapy in postmenopausal women being treated with calcium-vitamin D3 for osteoporosis, and to obtain exploratory data on the efficacy of the iron chelation treatment. The reduction in iron levels with deferasirox may provide a viable therapeutic option for mitigating the iron accumulation associated with PMOP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferasirox and calcium-vitamin D3 | Experimental | Drug: Deferasirox and calcium-vitamin D3, Drug: Calcium-vitamin D3Deferasirox is an orodispersible tablet and should be taken daily 30 minutes before breakfast, with a dose of 10 mg/Kg/day ± 5 mg/Kg/day during 12 month. Calcium 500 mg and Vitamin D3 800 IU should also be taken daily as a basic therapy. |
| Calcium-vitamin D3 | Placebo comparator | Drug: Calcium-vitamin D3Calcium 500 mg and Vitamin D3 800 IU are taken daily as a basic therapy. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lumbar spine or hip BMD T-score ≤-2.5 SD.
- Elevated serum ferritin (females: serum 500ng/ml≤ferritin≤1000ng/ml).
Key exclusion criteria (11 listed)
- Anemia < 10 g/dl
- Serum liver enzymes or bilirubin above the upper limit of normal at screening.
- Patients with creatinine clearance <60 ml/min will be excluded.
- Known allergy or contraindication to the administration of Deferasirox.
- History of blood transfusion during the 6 months prior to study entry.
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 |
|---|---|---|
| Deferasirox and calcium-vitamin D3deferasirox and calcium-vitamin D3 Deferasirox is an orodispersible tablet and should be taken daily 30 minutes before breakfast, with a dose of 10 mg/Kg/day ± 5 mg/Kg/day during 12 month. Calcium 500 mg and vitamin D3 800 IU should also be taken daily as a basic therapy. | Drug | Deferasirox and calcium-vitamin D3 |
| Calcium-vitamin D3Calcium 500 mg and vitamin D3 800 IU are taken daily as a basic therapy. | Drug | Calcium-vitamin D3, Deferasirox and calcium-vitamin D3 |
Primary outcome
Number of participants with adverse events
Time frame: 12 months
An adverse event was any untoward medical occurrence in participants, and did not necessarily need to have a causal relationship with the drug in the trial. The relationship of each adverse event to study drug or the severity of each adverse event was judged by the investigator, as described below. A serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions: fatal or life-threatening; requires inpatient hospitalization; persistent or significant disability/incapacity;
Number of participants with abnormal blood pressure, heart rate, body temperature, and/or physical examination that are related to the treatment
Time frame: 12 months
Bone mineral density
Time frame: Baseline, Month 6, Month 12
Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. Percent changes in DXA Bone Mineral Density from baseline to month 6 and month 12 of the trial in all patients. Percent change from Baseline was calculated as (BMD at Month 6 or Month 12 - BMD at Baseline)/BMD at Baseline * 100%.
5 secondary outcomes
Change from baseline in serum C-terminal telopeptide of type I collagen (β-CTX)
Time frame: Baseline, Month 3, Month 6, Month 9 and Month 12
Change from baseline in serum N-aminoterminal prepeptide of type I procollagen (P1NP)
Time frame: Baseline, Month 3, Month 6, Month 9 and Month 12
Change from baseline in serum ferritin
Time frame: Baseline, Month 3, Month 6, Month 9 and Month 12
Change from baseline in blood chemistry
Time frame: Baseline, Week 2, Week 4 and Month 3, Month 6, Month 9, Month 12 of the trial
Change from baseline in hematology
Time frame: Baseline, Week 2, Week 4 and Month 3, Month 6, Month 9, Month 12 of the trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Background: PubMed 22729843Kim BJ, Ahn SH, Bae SJ, Kim EH, Lee SH, Kim HK, Choe JW, Koh JM, Kim GS. Iron overload accelerates bone loss in healthy postmenopausal women and middle-aged men: a 3-year retrospective longitudinal study. J Bone Miner Res. 2012 Nov;27(11):2279-90. doi: 10.1002/jbmr.1692.
- Background: PubMed 22801718Mitchell F. Bone: high body iron stores lead to bone loss. Nat Rev Endocrinol. 2012 Sep;8(9):506. doi: 10.1038/nrendo.2012.127. Epub 2012 Jul 17. No abstract available.
- Background: PubMed 22525981Li GF, Pan YZ, Sirois P, Li K, Xu YJ. Iron homeostasis in osteoporosis and its clinical implications. Osteoporos Int. 2012 Oct;23(10):2403-8. doi: 10.1007/s00198-012-1982-1. Epub 2012 Apr 14.
- Background: PubMed 23523718Huang X, Xu Y, Partridge NC. Dancing with sex hormones, could iron contribute to the gender difference in osteoporosis? Bone. 2013 Aug;55(2):458-60. doi: 10.1016/j.bone.2013.03.008. Epub 2013 Mar 22. No abstract available.
- Background: PubMed 24414856Chen B, Yan YL, Liu C, Bo L, Li GF, Wang H, Xu YJ. Therapeutic effect of deferoxamine on iron overload-induced inhibition of osteogenesis in a zebrafish model. Calcif Tissue Int. 2014 Mar;94(3):353-60. doi: 10.1007/s00223-013-9817-4. Epub 2014 Jan 12.
- Background: PubMed 26170904Chen B, Li GF, Shen Y, Huang XI, Xu YJ. Reducing iron accumulation: A potential approach for the prevention and treatment of postmenopausal osteoporosis. Exp Ther Med. 2015 Jul;10(1):7-11. doi: 10.3892/etm.2015.2484. Epub 2015 May 8.
- Background: PubMed 24652331Shen GS, Yang Q, Jian JL, Zhao GY, Liu LL, Wang X, Zhang W, Huang X, Xu YJ. Hepcidin1 knockout mice display defects in bone microarchitecture and changes of bone formation markers. Calcif Tissue Int. 2014 Jun;94(6):632-9. doi: 10.1007/s00223-014-9845-8. Epub 2014 Mar 21.
- Background: PubMed 21911012Xu Y, Li G, Du B, Zhang P, Xiao L, Sirois P, Li K. Hepcidin increases intracellular Ca2+ of osteoblast hFOB1.19 through L-type Ca2+ channels. Regul Pept. 2011 Dec 10;172(1-3):58-61. doi: 10.1016/j.regpep.2011.08.009. Epub 2011 Sep 10.
- Background: PubMed 22570238Jia P, Xu YJ, Zhang ZL, Li K, Li B, Zhang W, Yang H. Ferric ion could facilitate osteoclast differentiation and bone resorption through the production of reactive oxygen species. J Orthop Res. 2012 Nov;30(11):1843-52. doi: 10.1002/jor.22133. Epub 2012 May 8.
- 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. This study is not recruiting at the moment.
You-Jia Xu, Ph.D,M.D. principal investigator
Second Afflilated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deferasirox and calcium-vitamin D3 and Calcium-vitamin D3 in people with Postmenopausal Osteoporosis, run by Second Affiliated Hospital of Soochow University at 1 site in China.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 17 May 2018. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact You-Jia Xu, Ph.D,M.D. (+86 512 67783746, xuyoujia@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: 12 months). The study lists 3 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 NCT02854722, which also lists 9 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 17 May 2018.