Osteoporosis, OsteopeniaNCT03898024
Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass
A study testing SHR-1222 in people with Osteoporosis, Osteopenia, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This study aims to investigate the effects of SHR-1222 on vascular inflammatory factors in patients with low bone mass. Read more about this study
- Who is it for?
- Ages 45 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- SHR-1222
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2019to 15 Aug 2020
- 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 45 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent;
- Male or postmenopausal female;
- Age ≥45 and ≤59 years old;
- The body mass index (BMI) ≥18.5kg/m2 and ≤28 kg/m2;
- T value of areal bone mineral density on any lumbar spine (L1-L4) or collum femoris>-2.5 and <-1;
- The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication;
- No smoking, alcohol or drugs abuse.
Who cannot join
- Any disease affecting bone metabolism;
- Past medical history of cerebral infarction or cerebral arterial thrombosis;
- Past medical history of myocardial infarction;
- Administration of the following drugs within 6m: Hormone replacement therapy, Calcitonin Parathyroid hormone (or any derivative), Supplemental Vitamin D>1,000 IU/day, Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed), Anabolic steroids, Calcitriol and available analogues, thiazide diuretics;
- Administration of the following drugs within 12m: Bisphosphonates, Fluoride for osteoporosis;
- A bone fracture within the previous 6 months;
Show all 18Show fewer
- A lumbar spine L1-L4 or femoral neck T-score ≤-2.5;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT) or total bilirubin, more than 1.5 x ULN during screening;
- 3 months prior to screening involved in any drug clinical subjects;
- Subjects determined by the researchers have any food, dietary supplement or drugs that affect SHR-1222 absorption, distribution, metabolism and excretion in 4 weeks prior to screening or within 5 half-lives;
- Serious infection, trauma or major surgery in 4 weeks prior to screening;
- A surgery plan during the study;
- Blood donation and transfusion in 3 months prior to screening;
- Unstable thyroid dysfunction in 6 months prior to screening;
- Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
- Intolerant to venous blood collection;
- A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar；
- Subjects with any other situation should not be involved, which determined by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
About this study
This study aims to investigate the effects of SHR-1222 on vascular inflammatory factors in patients with low bone mass.
Read the detailed description
In this study, total 50 patients with low bone mass will be enrolled and divided into 5 dose groups. In the lowest dose group 6 subjects will be recruited, among whom 4 will receive SHR-1222 and the other 2 will receive placebo. In each of the other 4 groups, 11 subjects will be recruited, among whom 9 will be administered with SHR-1222 and the other 2 with placebo.
Levels of nitric oxide (NO), Endothelin-1 (ET-1), plasminogen activator inhibitor-1 (PAI-1) and hypersensitivity C-reactive protein (hs-CRP) will be detected in patients before and after the SHR-1222 injection.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- SHR-1222, Placebo
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1222Drug
Pharmaceutical form: water injection; Route of administration: subcutaneous
PlaceboDrug
Pharmaceutical form: water injection; Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | A single subcutaneous injection of SHR-1222 dose 1 versus placebo Receives: Drug: SHR-1222; Drug: Placebo |
| Cohort 2 | Experimental | A single subcutaneous injection of SHR-1222 dose 2 versus placebo Receives: Drug: SHR-1222; Drug: Placebo |
| Cohort 3 | Experimental | A single subcutaneous injection of SHR-1222 dose 3 versus placebo Receives: Drug: SHR-1222; Drug: Placebo |
| Cohort 4 | Experimental | A single subcutaneous injection of SHR-1222 dose 4 versus placebo Receives: Drug: SHR-1222; Drug: Placebo |
| Cohort 5 | Experimental | A single subcutaneous injection of SHR-1222 dose 5 versus placebo Receives: Drug: SHR-1222; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of serum nitric oxide (NO) change after the administration of SHR-1222
NO level will be detected by nitrite/nitrate assay (colorimetric).
Measured: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
Assessment of serum Endothelin-1 (ET-1) change after the administration of SHR-1222
ET-1 level will be detected by ELISA.
Measured: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
Assessment of serum plasminogen activator inhibitor-1 (PAI-1) change after the administration of SHR-1222
PAI-1 level will be detected by ELISA.
Measured: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
Assessment of serum hypersensitivity C-reactive protein (hs-CRP) change after the administration of SHR-1222
hs-CRP level will be detected by immunoturbidimetry assay.
Measured: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start15 Apr 2019
- Primary completion27 Jul 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, OsteopeniaStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguang Zhou, Second Xiangya Hospital of Central South University
- Investigators
- Zhiguang Zhou, MD, Principal investigator, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898024
- Sponsor's protocol ID
- 2019 SHR-1222
- Status last verified
- Jun 2022
- First submitted
- 26 Mar 2019
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass
- ClinicalTrials.gov ID
- NCT03898024
- Acronym / sponsor ID
- 2019 SHR-1222
- Conditions
- Osteoporosis, Osteopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 27 Jul 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 1 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.
This study aims to investigate the effects of SHR-1222 on vascular inflammatory factors in patients with low bone mass.
Detailed description
In this study, total 50 patients with low bone mass will be enrolled and divided into 5 dose groups. In the lowest dose group 6 subjects will be recruited, among whom 4 will receive SHR-1222 and the other 2 will receive placebo. In each of the other 4 groups, 11 subjects will be recruited, among whom 9 will be administered with SHR-1222 and the other 2 with placebo.
Levels of nitric oxide (NO), Endothelin-1 (ET-1), plasminogen activator inhibitor-1 (PAI-1) and hypersensitivity C-reactive protein (hs-CRP) will be detected in patients before and after the SHR-1222 injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SHR-1222, Drug: PlaceboA single subcutaneous injection of SHR-1222 dose 1 versus placebo |
| Cohort 2 | Experimental | Drug: SHR-1222, Drug: PlaceboA single subcutaneous injection of SHR-1222 dose 2 versus placebo |
| Cohort 3 | Experimental | Drug: SHR-1222, Drug: PlaceboA single subcutaneous injection of SHR-1222 dose 3 versus placebo |
| Cohort 4 | Experimental | Drug: SHR-1222, Drug: PlaceboA single subcutaneous injection of SHR-1222 dose 4 versus placebo |
| Cohort 5 | Experimental | Drug: SHR-1222, Drug: PlaceboA single subcutaneous injection of SHR-1222 dose 5 versus placebo |
Who may qualify
- Ages
- 45 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent;
- Male or postmenopausal female;
- Age ≥45 and ≤59 years old;
- The body mass index (BMI) ≥18.5kg/m2 and ≤28 kg/m2;
- T value of areal bone mineral density on any lumbar spine (L1-L4) or collum femoris>-2.5 and <-1;
Key exclusion criteria (18 listed)
- Any disease affecting bone metabolism;
- Past medical history of cerebral infarction or cerebral arterial thrombosis;
- Past medical history of myocardial infarction;
- Administration of the following drugs within 6m: Hormone replacement therapy, Calcitonin Parathyroid hormone (or any derivative), Supplemental Vitamin D>1,000 IU/day, Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed), Anabolic steroids, Calcitriol and available analogues, thiazide diuretics;
- Administration of the following drugs within 12m: Bisphosphonates, Fluoride for osteoporosis;
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 |
|---|---|---|
| SHR-1222Pharmaceutical form: water injection; Route of administration: subcutaneous | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| PlaceboPharmaceutical form: water injection; Route of administration: subcutaneous | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Assessment of serum nitric oxide (NO) change after the administration of SHR-1222
Time frame: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
NO level will be detected by nitrite/nitrate assay (colorimetric).
Assessment of serum Endothelin-1 (ET-1) change after the administration of SHR-1222
Time frame: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
ET-1 level will be detected by ELISA.
Assessment of serum plasminogen activator inhibitor-1 (PAI-1) change after the administration of SHR-1222
Time frame: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
PAI-1 level will be detected by ELISA.
Assessment of serum hypersensitivity C-reactive protein (hs-CRP) change after the administration of SHR-1222
Time frame: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration
hs-CRP level will be detected by immunoturbidimetry assay.
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 30 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis, Osteopenia
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
RecruitingObservational study
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia
Active, not recruiting
Sickle Cell Disease (SCD) Bone Pain Study
Sickle Cell Disease, Sickle Cell Anemia
Active, not recruiting
Physical Activity Guarantees Bone Density.
Osteoporosis, Osteopenia
RecruitingPhase 4
The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation
Postmenopausal Osteoporosis, Postmenopausal Osteopenia
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.
Zhiguang Zhou, MD principal investigator
Second Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHR-1222 in people with Osteoporosis, Osteopenia, run by Second Xiangya Hospital of Central South 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 7 inclusion and 18 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 30 Jun 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 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. 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?
Assessment of serum nitric oxide (NO) change after the administration of SHR-1222 (time frame: Day0 before the administration and Day 2, 4, 7, 15, 29, 43, 57 after the administration). 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?
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 30 Jun 2022.