Glucocorticoid Induced OsteoporosisPhase 2NCT05397938
Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis
A Phase 2 study testing JMT103 and Alendronate sodium in people with Glucocorticoid Induced Osteoporosis, run by Shanghai JMT-Bio Inc. at 1 site in China.
Trial summary
This is a randomized, double-blind, double-dummy, positive-controlled phase II interventional study designed to evaluate the efficacy and safety of JMT103 in the treatment of glucocorticoid induced osteoporosis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glucocorticoid Induced Osteoporosis
- What is being tested?
- JMT103 and Alendronate sodium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2022to 1 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Both genders aged 18 years or above, capable of autonomous action;
- 2. In the course of an ongoing glucocorticoid treatment for at least 3months with prednisone≥7.5 mg or its equivalent taken currently, and expected to be treated of no less than 6 months in total;
- 3. Any of the followings: a. History of osteoporotic fracture; b. Age≥50 years and lumbar (L1-L4) or total hip BMD of T≤-2.0 by DXA; c. Age≥40 years and a predicted 10-year risk of major osteoporotic fractures ≥ 10% (vertebral body, forearm, hip, shoulder) or a predicted 10-year risk of hip fracture ≥ 1% estimated by hormone adjusted FRAX;
- 4. At least two lumbar vertebrae from L1 to L4 evaluable by DXA;
- 5. Uncompromised ability to maintain good communication with investigator and comply with all required study procedures;
- 6. A signed informed consent under the capability of thorough understanding.
Who cannot join
- 1. Currently pregnant or lactating; For those of child bearing potential, refusal to use effective forms of contraception from signing informed consent to 6 months after last administration;
- 2. Previous or ongoing osteomyelitis or necrosis of jaw; Unhealed dental/oral operation wound; Acute jaw bone or dental disease requiring oral surgery; Planned invasive dental surgery during the study period;
- 3. Selected into other clinical studies of which the latest administration is less than 4 weeks (or 5 elimination half-lives, whichever is longer) from the first administration in this study;
- 4. Intravenous use of bisphosphonates, fluoride or strontium in the past 5 years; Oral bisphosphonates use for more than 3 years in total, or between 3 months to 3 years in total with the last medication used in the past 1 year prior to signing informed consent;
- 5. Receptor Activator for Nuclear Factor-κ B Ligand (RANKL) antibody used within 6 months prior to screening;
- 6. Administration of any of the following bone metabolism affecting drugs within 3 months prior to screening: a. Parathyroid hormone (PTH) or PTH derivatives (e.g., teriparatide); b. Anabolic hormones or testosterone; c. Sex hormone replacement; d. Selective estrogen receptor modulators (SERMs, e.g., raloxifene); e. Calcitonin; f. Other bone metabolism activating drugs include anticonvulsants (except benzodiazepines) and heparin; g. Long-term systemic use of ketoconazole, adrenocorticotropic hormone (ACTH), cinacalcet, aluminium, lithium, protease inhibitor, methotrexate or gonadotropin releasing hormone agonist;
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- 7. Administration of any of the following biologic agents within 4 weeks prior to screening: a. Anti-alpha 4 integrin antibody (e.g., natalizumab); b. Anti CD4/CD8 T-cells (e.g., alefacept); c. Anti-IL12/anti-IL23 (e.g., ustekinumab); d. CTLA4 inhibitor (e.g., abatacept); e. IL1 receptor antagonist (e.g., anakinra); f. IL6 inhibitor (e.g., tocilizumab); g. Monoclonal antibody to CD20 (e.g., rituximab); h. TNF antagonist (e.g., adalimumab, certolizumab, golimumab, etanercept, infliximab);
- 8. Requirement of >1 biologic agent (other than trial drug) for the treatment of underlying inflammatory disease;
- 9. Bone metabolic disorders (other than osteoporosis alone): a. Hypo- or hyperparathyroidism; b. Osteogenesis imperfecta; c. Malignant tumor; d. Hypopituitarism; e. Hyperprolactinemia; f. Acromegaly; g. Paget disease of bone;
- 10. Hyperthyroidism or hypothyroidism, except for a stable replacement therapy for at least 3 months turning out a normal ranged TSH or increased TSH≤10.0 μIU/mL with normal ranged FT4;
- 11. Malabsorption syndrome or various gastrointestinal diseases associated with malabsorption, such as Crohn's disease and chronic pancreatitis
- 12. Liver cirrhosis or unstable liver disease (defined as ascites, hepatic encephalopathy, coagulation disorder, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice); Known or clinically significant biliary abnormalities judged by investigator (except Gilbert syndrome, asymptomatic gallstones and gallbladder polyps);
- 13. Previous organ or bone marrow transplantation;
- 14. Unwilling to take vitamin D and calcium supplements as the procedure requires;
- 15. Uncontrolled concurrent diseases, including but not limited to: uncontrolled diabetes (> 2 grade according to NCI-CTCAE5.0), symptomatic congestive heart failure, hypertension with blood pressure greater than 150/90 mmHg after standard treatment, unstable angina pectoris, arrhythmia requiring medication or instrument treatment, myocardial infarction history within 6 months, and echocardiography with left ventricular ejection fraction < 50%;
- 16. 25[OH] vitamin D level < 20 ng/mL, retest allowed after 5000 iu/day vitamin D added for 4-6 weeks;
- 17. Current hypocalcemia or hypercalcemia, defined as albumin-corrected serum calcium level of ≤ 2.2 mmol/L (8.8 mg/dL) or ≥ 2.9 mmol/L (11.5 mg/dL) (no supplementation of calcium for at least 8 hours before test);
- 18. Serum whole parathyroid hormone (iPTH) > 65 pg/mL;
- 19. Any of the followings: a. Routine blood test (shall no treatment such as blood transfusion or hematopoietic stimulating factor was received within 7 days): absolute neutrophil count < 1.5×10^9/L, platelet < 75 × 10^9/L, or hemoglobin < 90 g/L; b. Liver function test: total bilirubin > 1.5 × upper limit of normal value (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN (retest allowed after 2-4 weeks for AST and ALT); c. Renal function test: estimated glomerular filtration rate (eGFR) < 35 L/(min·1.73m^2); d. Coagulation function test: activated partial thromboplastin time > 1.5 × ULN, or international normalized ratio (INR) > 1.5 × ULN;
- 20. Active bacterial or fungal infections requiring systematic treatment within 7 days prior to randomization;
- 21. HIV infection, active hepatitis, known or suspected active tuberculosis;
- 22. Any malignant tumor within 5 years prior to screening, except those expected to be cured (e.g., completely resected in situ skin basal cell or squamous cell carcinoma, cervical cancer or breast ductal cancer, etc.);
- 23. Known allergic/hypersensitive reaction or intolerance to JMT103, positive control drug, calcium and vitamin D;
- 24. Contraindicated to alendronate therapy: abnormalities of the esophagus which delay esophageal emptying (e.g., stricture or achalasia), or inability to stand or sit upright for at least 30 minutes;
- 25. BMD measurement by DXA interrupted: < 2 measurable lumbar vertebrae; Interrupting height, weight or waist circumference; Severe scoliosis and other measurement affecting conditions;
- 26. Considered unsuitable for the research project by investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: A Randomized, Double-blind, Double-dummy, Positive-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis
This is a randomized, double-blind, double-dummy, positive-controlled phase II interventional study designed to evaluate the efficacy and safety of JMT103 in the treatment of glucocorticoid induced osteoporosis patients. Patients will be enrolled and randomized to 3 treatment groups, JMT103 60 mg group (and alendronate sodium tablet placebo), JMT103 90 mg group (and alendronate sodium tablet placebo), and alendronate sodium 70 mg active comparator group (and JMT103 placebo). The primary outcome measure is percent change from baseline in lumbar bone mineral density (BMD) at 12 months of treatment. Besides, percent change of lumbar BMD at 6 months, percent change of total hip and femoral neck BMD at 12 months, and the incidence of new fracture at 12 months will be evaluated. Biomarkers of s-CTX and PINP, PK evaluation of JMT103 serum drug concentration, immunogenicity evaluation of ADA and Nab, and adverse events will be also collected.
- Conditions
- Glucocorticoid Induced Osteoporosis
- Being tested
- JMT103, Alendronate sodium, JMT103 placebo, Alendronate sodium placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT103Drug
JMT103, subcutaneous injection, once every 6 months (Q6M)
Alendronate sodiumDrug
Alendronate sodium tablet, once every week (QW)
JMT103 placeboDrug
JMT103 placebo, subcutaneous injection, once every 6 months (Q6M)
Alendronate sodium placeboDrug
Alendronate sodium tablet placebo, once every week (QW)
| Study group | Role | What they receive |
|---|---|---|
| JMT103 60 mg group | Experimental | Patients will be administrated with JMT103 60 mg subcutaneously every 6 months (Q6W) and alendronate sodium tablet placebo once every week (QW). Receives: Drug: JMT103; Drug: Alendronate sodium placebo |
| JMT103 90 mg group | Experimental | Patients will be administrated with JMT103 90 mg subcutaneously every 6 months (Q6W) and alendronate sodium tablet placebo once every week (QW). Receives: Drug: JMT103; Drug: Alendronate sodium placebo |
| Alendronate sodium group | Active comparator | Patients will be administrated with alendronate sodium tablet orally 70 mg weekly (QW) and JMT103 placebo subcutaneously every 6 months (Q6W). Receives: Drug: Alendronate sodium; Drug: JMT103 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change rate of lumbar bone mineral density (BMD) from baseline at 12 months
Measured: 12 months
Secondary outcomes (7)
Change rate of lumbar spine BMD from baseline at 6 months
Measured: 6 months
Change rate of total hip and femoral neck BMD from baseline at 12 months
Measured: 12 months
Change rate of serum type I collagen cross-linked C-terminal peptide (s-CTX) and procollagen type I N-terminal propeptide (PINP) from baseline at 1, 3, 6 and 12 months
Measured: 1, 3, 6 and 12 months
Incidence of new fractures at 12 months (vertebral and non-vertebral)
Measured: 12 months
Types and proportions of adverse events
Measured: signing informed consent - 6 months after the last administration
JMT103 serum drug concentration
Measured: Day 1 - 12 months
Incidence of JMT103 anti-drug antibodies (ADA) and neutralizing antibodies (Nab)
Measured: Day 1 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start15 Jun 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucocorticoid Induced OsteoporosisStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397938
- Sponsor's protocol ID
- JMT103-CSP-006
- Status last verified
- Dec 2021
- First submitted
- 25 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Positive-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis
- ClinicalTrials.gov ID
- NCT05397938
- Acronym / sponsor ID
- JMT103-CSP-006
- Conditions
- Glucocorticoid Induced Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 31 May 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.
This is a randomized, double-blind, double-dummy, positive-controlled phase II interventional study designed to evaluate the efficacy and safety of JMT103 in the treatment of glucocorticoid induced osteoporosis patients. Patients will be enrolled and randomized to 3 treatment groups, JMT103 60 mg group (and alendronate sodium tablet placebo), JMT103 90 mg group (and alendronate sodium tablet placebo), and alendronate sodium 70 mg active comparator group (and JMT103 placebo). The primary outcome measure is percent change from baseline in lumbar bone mineral density (BMD) at 12 months of treatment. Besides, percent change of lumbar BMD at 6 months, percent change of total hip and femoral neck BMD at 12 months, and the incidence of new fracture at 12 months will be evaluated. Biomarkers of s-CTX and PINP, PK evaluation of JMT103 serum drug concentration, immunogenicity evaluation of ADA and Nab, and adverse events will be also collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JMT103 60 mg group | Experimental | Drug: JMT103, Drug: Alendronate sodium placeboPatients will be administrated with JMT103 60 mg subcutaneously every 6 months (Q6W) and alendronate sodium tablet placebo once every week (QW). |
| JMT103 90 mg group | Experimental | Drug: JMT103, Drug: Alendronate sodium placeboPatients will be administrated with JMT103 90 mg subcutaneously every 6 months (Q6W) and alendronate sodium tablet placebo once every week (QW). |
| Alendronate sodium group | Active comparator | Drug: Alendronate sodium, Drug: JMT103 placeboPatients will be administrated with alendronate sodium tablet orally 70 mg weekly (QW) and JMT103 placebo subcutaneously every 6 months (Q6W). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Both genders aged 18 years or above, capable of autonomous action;
- 2. In the course of an ongoing glucocorticoid treatment for at least 3months with prednisone≥7.5 mg or its equivalent taken currently, and expected to be treated of no less than 6 months in total;
- 3. Any of the followings: a. History of osteoporotic fracture; b. Age≥50 years and lumbar (L1-L4) or total hip BMD of T≤-2.0 by DXA; c. Age≥40 years and a predicted 10-year risk of major osteoporotic fractures ≥ 10% (vertebral body, forearm, hip, shoulder) or a predicted 10-year risk of hip fracture ≥ 1% estimated by hormone adjusted FRAX;
- 4. At least two lumbar vertebrae from L1 to L4 evaluable by DXA;
- 5. Uncompromised ability to maintain good communication with investigator and comply with all required study procedures;
Key exclusion criteria (26 listed)
- 1. Currently pregnant or lactating; For those of child bearing potential, refusal to use effective forms of contraception from signing informed consent to 6 months after last administration;
- 2. Previous or ongoing osteomyelitis or necrosis of jaw; Unhealed dental/oral operation wound; Acute jaw bone or dental disease requiring oral surgery; Planned invasive dental surgery during the study period;
- 3. Selected into other clinical studies of which the latest administration is less than 4 weeks (or 5 elimination half-lives, whichever is longer) from the first administration in this study;
- 4. Intravenous use of bisphosphonates, fluoride or strontium in the past 5 years; Oral bisphosphonates use for more than 3 years in total, or between 3 months to 3 years in total with the last medication used in the past 1 year prior to signing informed consent;
- 5. Receptor Activator for Nuclear Factor-κ B Ligand (RANKL) antibody used within 6 months prior to screening;
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 |
|---|---|---|
| JMT103JMT103, subcutaneous injection, once every 6 months (Q6M) | Drug | JMT103 60 mg group, JMT103 90 mg group |
| Alendronate sodiumAlendronate sodium tablet, once every week (QW) | Drug | Alendronate sodium group |
| JMT103 placeboJMT103 placebo, subcutaneous injection, once every 6 months (Q6M) | Drug | Alendronate sodium group |
| Alendronate sodium placeboAlendronate sodium tablet placebo, once every week (QW) | Drug | JMT103 60 mg group, JMT103 90 mg group |
Primary outcome
Change rate of lumbar bone mineral density (BMD) from baseline at 12 months
Time frame: 12 months
7 secondary outcomes
Change rate of lumbar spine BMD from baseline at 6 months
Time frame: 6 months
Change rate of total hip and femoral neck BMD from baseline at 12 months
Time frame: 12 months
Change rate of serum type I collagen cross-linked C-terminal peptide (s-CTX) and procollagen type I N-terminal propeptide (PINP) from baseline at 1, 3, 6 and 12 months
Time frame: 1, 3, 6 and 12 months
Incidence of new fractures at 12 months (vertebral and non-vertebral)
Time frame: 12 months
Types and proportions of adverse events
Time frame: signing informed consent - 6 months after the last administration
JMT103 serum drug concentration
Time frame: Day 1 - 12 months
Incidence of JMT103 anti-drug antibodies (ADA) and neutralizing antibodies (Nab)
Time frame: Day 1 - 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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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.
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 JMT103 and Alendronate sodium in people with Glucocorticoid Induced Osteoporosis, run by Shanghai JMT-Bio Inc. 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 6 inclusion and 26 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 31 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 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.
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 Shunqiang He (+86-010-63398491, heshunqiang@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change rate of lumbar bone mineral density (BMD) from baseline at 12 months (time frame: 12 months). 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 31 May 2022.