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Postmenopausal OsteoporosisPhase 2NCT05278338

Efficacy and Safety of JMT103 in the Treatment of Postmenopausal Women With Osteoporosis

A Phase 2 study testing JMT103 and Denosumab in people with Postmenopausal Osteoporosis, run by Shanghai JMT-Bio Inc. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is to evaluate the efficacy and safety of JMT103 in the treatment of postmenopausal women with osteoporosis. Read more about this study

Who is it for?
Ages 50 to 85 years, women only
Conditions the study is for
Postmenopausal Osteoporosis
What is being tested?
JMT103 and Denosumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteChina
Study dates
21 Apr 2022to 31 Mar 2024
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 50 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Postmenopausal women, capable of autonomous action, aged 50-85 years (inclusive);
  • Menopause is defined as menopause for ≥2 years, which can be spontaneous amenorrhea for ≥2 years or bilateral oophorectomy for ≥2 years. If bilateral oophorectomy status is unknown, the follicle stimulating hormone (FSH) level should be greater than or equal to 40 mIU/mL to confirm the menopausal status;
  • Meet the diagnostic criteria for osteoporosis: Based on the results of BMD measurement by dual-energy X-ray absorptiometry (DXA), lumbar spine (mean BMD of L1-L4 or more than 2 measurable vertebral bodies), total hip or femur neck BMD is -4.0 ≤ T-value ≤ -2.5; or lumbar spine, total hip or femoral neck BMD is -2.5 < T-value < -1.0 and a history of fragility fractures of the proximal humerus, pelvis or distal forearm; or a history of fragility fractures of the hip or vertebral bodies;
  • The subject can maintain good communication with the investigator and comply with the various requirements of the clinical trial, and is expected to be able to complete the entire trial process;
  • Be able to be fully informed and sign an informed consent form.

Who cannot join

  • A history of fractures of more than 2 vertebral bodies;
  • Subjects with bone metabolic diseases other than osteoporosis: a. various metabolic bone diseases, such as osteomalacia or osteogenesis imperfecta, as these diseases may interfere with the study results; b. Paget's disease; c. Cushing syndrome; d. hyperprolactinemia; e. others;
  • Currently suffering from hyperparathyroidism or hypoparathyroidism;
  • Hyperthyroidism or hypothyroidism. Subjects with hypothyroidism on stable (for at least 3 months) thyroid hormone replacement therapy can be selected, but the following conditions must be met: a. If the TSH level is below the normal range, the subject cannot participate in the study. b. If the TSH level is elevated (>5.5 μIU/mL but ≤10.0 μIU/mL), serum T4 should be measured. If the serum T4 is in the normal range, the subject can be selected. If the serum T4 is outside the normal range, the subject cannot participate in the study. c. If the TSH level is greater than 10.0 μIU/mL, the subject cannot participate in the study;
  • Rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus and other rheumatic immune diseases;
  • Malabsorption syndrome: Malabsorption syndrome or various gastrointestinal diseases related to malabsorption, such as Crohn's disease and chronic pancreatitis;
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  • Previously or currently suffering from osteomyelitis or osteonecrosis of the jaw; dental surgery or oral surgery wounds that have not healed; acute dental or jaw disease requiring oral surgery; those who have planned to undergo invasive dental surgery during the study period;
  • Liver disease: a. liver cirrhosis; b. unstable liver disease (defined as ascites, hepatic encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice); c. known or clinically significant biliary tract abnormalities judged by the investigator (except Gilbert syndrome, asymptomatic gallstones and gallbladder polyps);
  • Uncontrolled concomitant diseases, including but not limited to: uncontrolled diabetes (>grade 2, NCI-CTCAE 5.0), symptomatic congestive heart failure, hypertension (blood pressure is still ≥150/90 mmHg after standard treatment), unstable angina, sick sinus syndrome (>grade 2, NCI-CTCAE 5.0), severe arrhythmia, history of myocardial infarction within the past 6 months and echocardiogram showing left ventricular ejection fraction <50%;
  • Active bacterial or fungal infection requiring systemic treatment within 7 days before randomization;
  • Those with active hepatitis B [HBsAg positive with HBV-DNA exceeding 1000 copies/mL (500 IU/mL) or higher than the lower limit of detection, whichever is lower]; subjects with active hepatitis C (HCV antibody positive with HCV-RNA level higher than the upper limit of detection); HIV antibody or syphilis antibody positive;
  • Those who are known to have active tuberculosis (TB) or suspected of active TB;
  • Those with malignant tumors within 5 years before screening, except for tumors that are expected to be cured after treatment (such as completely resected basal cell carcinoma or squamous cell carcinoma, cervical cancer or ductal carcinoma of the breast in situ, etc.);
  • Those who have used intravenous bisphosphonates, fluorides or strontium agents for the treatment of osteoporosis in the last 5 years (from the signing of the informed consent form), or oral bisphosphonates for the treatment of osteoporosis (from the date of signing the informed consent form): a. those with cumulative use greater than or equal to 3 years cannot be selected; b. those with cumulative use greater than 3 months but less than 3 years, and the last dose administered within 1 year before the date of signing the informed consent form cannot be selected (those whose last dose was one year or more before the date of signing the informed consent form can be selected); c. those with cumulative use less than or equal to 3 months can be selected;
  • Those who have used anti-receptor activator of nuclear factor-κB ligand (RANKL) antibody within one year before prior screening;
  • Those who have received drugs that affect bone metabolism within 3 months before screening: a. parathyroid hormone (PTH) or PTH derivatives, such as teriparatide; b. anabolic hormones or testosterone; c. glucocorticoids (equivalent to daily use > 5 mg of prednisone > 10 days); d. sex hormone replacement therapy; e. selective estrogen receptor modulators (SERM), such as raloxifene; f. calcitonin, calcitriol or vitamin D derivatives (cumulative use> 30 days, and used within 6 weeks before the signing of the informed consent form); g. other bone active drugs including anticonvulsants (except benzodiazepines) and heparin; h. long-term systemic use of ketoconazole, adrenocorticotropic hormone (ACTH), cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, or gonadotropin releasing hormone agonists;
  • Currently receiving other clinical study drugs, and the last dose administered less than 4 weeks or 5 elimination half-lives (t1/2) from the date of study drug administration (whichever is longer);
  • Those known to have allergies or hypersensitivity to JMT103 formulations, control drugs, calcium and vitamin D preparations;
  • Those who have received the COVID-19 vaccine within 4 weeks before administration;
  • Those whose blood system, liver and kidney function, and coagulation system examinations meet the following conditions:
  • Blood system (without receiving blood transfusion or hematopoietic stimulating factor treatment within 7 days before the signing of the informed consent form): absolute neutrophil value (ANC) <1.5×10^9/L; platelet (PLT) <75×10^9/L; hemoglobin (Hb) <90 g/L;
  • Liver function: total bilirubin (TBIL)>1.5×upper limit of normal (ULN), alanine aminotransferase (ALT)>2.5×ULN (subjects are allowed to be retested after a rest for 2-4 weeks; if the retest shows ALT<2.5×ULN, they can be included in this study), aspartate aminotransferase (AST)> 2.5×ULN; for subjects with liver metastasis or liver cancer: TBIL>3×ULN, ALT>5×ULN, and AST> 5×ULN;
  • Kidney function: urine protein ≥2+ or 24-hour urine protein quantitation ≥1.0 g; creatinine clearance* (CrCl) calculated value <60 mL/min;
  • Coagulation function: activated partial thromboplastin time: (APTT)>1.5×ULN; international normalized ratio (INR)>1.5×ULN;
  • Vitamin D deficiency: 25-(OH) vitamin D <20 ng/mL. Subjects are allowed to receive vitamin D 5000 IU/day for supplementation, and take a retest after 4-6 weeks. If 25-(OH) vitamin D is retested to be >20 ng/mL, the subjects can be enrolled;
  • Blood calcium abnormalities: current hypocalcemia or hypercalcemia. Serum calcium or serum calcium corrected for albumin is ≤2.2 mmol/L (8.8 mg/dL) or ≥2.9 mmol/L (11.5 mg/dL); subjects are not allowed to use calcium supplements at least 8 hours before blood draw for serum calcium screening determination; Conditions that affect the determination of bone mineral density by dual-energy
  • Conditions that affect the determination of BMD by dual-energy X-ray absorptiometry: less than 2 measurable lumbar vertebral bodies; height, weight, or waist circumference that may hinder accurate measurement; severe scoliosis and other conditions that affect BMD testing;
  • Subjects who are judged by the investigator to be at high risk of fractures and must receive active drug treatment;
  • Subjects who are judged by the investigator to be unsuitable for inclusion in the study.

Trial locations and contacts

1 site in 1 country.

Rong Du contact

0086＋010-56081675

durong@mail.ecspc.com

China1 site, 1 recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

    Hanqing Cai, PhD

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo/Positive-controlled Phase II Study to Evaluate the Efficacy and Safety of JMT103 in Postmenopausal Women With Osteoporosis

This study is to evaluate the efficacy and safety of JMT103 in the treatment of postmenopausal women with osteoporosis.

Read the detailed description

This study is a randomized, double-blind, placebo/positive-controlled Phase II clinical study to evaluate the efficacy, safety, immunogenicity and pharmacokinetic characteristics of JMT103 in the treatment of postmenopausal women with osteoporosis. Subjects will be screened within -28 days before treatment, and subjects who meet the inclusion/exclusion criteria will be included in the study. The enrolled postmenopausal women with osteoporosis who meet the diagnostic criteria for osteoporosis will be randomized in a 1:1:1:1:1 ratio into Test Group a (JMT103 45 mg group), Test Group b (JMT103 60 mg group), Test Group c (JMT103 90 mg group), Control Group d (denosumab 60 mg group) and Control Group e (placebo group). JMT103,denosumab and placebo will be administered as a single subcutaneous (SC) injection at the beginning of the treatment phase and at 6 months following the initial dose. Each subject will be followed up for 12 months after the first administration. Throughout the research process, subjects will be required to supplement ≥1000 mg of calcium and ≥800 IU of vitamin D every day.

Being tested
JMT103, Denosumab, Placebo
Medical subject headings
Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JMT103Drug

    subcutaneous injection, once every 6 months (Q6M), with a total of 2 administrations

  • DenosumabDrug

    subcutaneous injection, once every 6 months (Q6M), with a total of 2 administrations

  • PlaceboDrug

    subcutaneous injection, once every 6 months (Q6M), with a total of 2 administrations

Study groups in NCT05278338
Study groupRoleWhat they receive
Group aExperimentalJMT103 45 mg
Receives: Drug: JMT103
Group bExperimentalJMT103 60 mg
Receives: Drug: JMT103
Group cExperimentalJMT103 90 mg
Receives: Drug: JMT103
Group dActive comparatorDenosumab 60 mg
Receives: Drug: Denosumab
Group ePlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change rate of lumbar bone mineral density (BMD) from baseline at 12 months of JMT103 treatment

    Dual-energy X-ray absorptiometry (DXA) will be performed to measure the bone mineral density of the subject's lumbar spine (the mean BMD of L1-L4 or more than 2 measurable vertebral bodies), the total hip and the femoral neck during the screening period, and at 3 months, 6 months and 12 months after the first administration and early withdrawal. Bone mineral density will be assessed centrally by DXA.

    Measured: Baseline and 12 months

Secondary outcomes (7)

  1. Change rate of lumbar spine BMD from baseline at 6 months of JMT103 treatment

    Measured: Baseline and 6 months

  2. Change rate of total hip and femoral neck BMD from baseline at 12 months of JMT103 treatment

    Measured: Baseline and 12 months

  3. Change rate of serum type I collagen cross-linked C-terminal peptide (s-CTX) from baseline at 1, 3, 6 and 12 months of treatment

    In this study, the central laboratory will be entrusted with the testing of biomarker samples. About 3.5 mL of venous whole blood will be collected each time.

    Measured: Day 1,15,29 and 3,6,12 months

  4. Change rate of type I procollagen N-terminal propeptide (PINP) from baseline at 1, 3, 6 and 12 months of treatment

    In this study, the central laboratory will be entrusted with the testing of biomarker samples. About 3.5 mL of venous whole blood will be collected each time.

    Measured: Day 1,15,29 and 3,6,12 months

  5. PK evaluation indicator: JMT103 serum drug concentration

    Venous blood samples will be collected at the specified time points, about 3.5 mL each time, the actual PK blood collection time should be recorded in the eCRF.

    Measured: Day 2,15,29 and 3,6,12 months

  6. Incidence of JMT103 anti-drug antibodies (ADA) and neutralizing antibodies (NAB)

    Blood samples will be collected at the specified time points, about 3.5 ml each time. The JMT103 anti-drug antibody (ADA) in the serum will be tested by electrochemical immunoassay. ADA-positive serum samples will be tested for neutralizing antibodies (NAB).

    Measured: Day 1,29 and 3,6,12 months

  7. Types and proportions of adverse events

    An adverse event (AE) can be any unfavorable and unanticipated signs (including abnormal laboratory findings), symptoms, or diseases temporally related to the used (study) drug, regardless of whether it is related to the drug or not. A serious adverse event (SAE) refers to any adverse event that meets one of the following criteria:

    Leading to death; Life-threatening; Requiring hospitalization or prolongation of hospitalization; Permanent or severe disability or loss of function; Congenital abnormalities or birth defects; Other significant medical events judged by the investigator.

    Measured: From signing the informed consent form to 6 months after the last administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2022
  2. Study start21 Apr 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Mar 2024 (estimated)

Resources

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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05278338
Sponsor's protocol ID
JMT103-CSP-008
Status last verified
Jul 2022
First submitted
8 Mar 2022
Last updated
18 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chi Y, Li Y, Cheng Q, Cai H, Zeng Y, Sheng H, Song B, Li H, Shen L, Li M, Xing Y, Cheng M, Ma Y, Wang D, Zhu M, Lu W, Yan S, Zhang X, Yuan J, Yang B, Li J, Wang J, Wu Z, Xia W. Efficacy and safety of narlumosbart, an anti-RANKL monoclonal antibody, in postmenopausal women with osteoporosis: a multi-center, randomized, double-blind, placebo- and active-controlled, phased II study. EClinicalMedicine. 2025 Jul 4;85:103329. doi: 10.1016/j.eclinm.2025.103329. eCollection 2025 Jul.

    PubMed 40686685

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JMT103 and Denosumab in people with Postmenopausal 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 5 inclusion and 29 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 18 Jul 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. 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 Rong Du (0086＋010-56081675, durong@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 of JMT103 treatment (time frame: Baseline and 12 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 NCT05278338, which also lists 1 linked publication.

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 18 Jul 2022.

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