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

NCT05278338 | Unknown Phase 2

• 1 other identifier: JMT103-CSP-008
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (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.

  Baseline and 12 months

Secondary Outcomes (7)

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

  Baseline and 6 months

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

  Baseline and 12 months

• 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

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

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

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

• PK evaluation indicator: JMT103 serum drug concentration

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

Study Arms (5)

Group a

EXPERIMENTAL

JMT103 45 mg

Drug: JMT103

Group b

EXPERIMENTAL

JMT103 60 mg

Drug: JMT103

Group c

EXPERIMENTAL

JMT103 90 mg

Drug: JMT103

Group d

ACTIVE COMPARATOR

Denosumab 60 mg

Drug: Denosumab

Group e

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

JMT103 DRUG

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

Group a; Group b; Group c

Denosumab DRUG

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

Group d

Placebo DRUG

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

Group e

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

Study Sites (1)

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40686685 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Weibo Xia

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Du

CONTACT

0086＋010-56081675; durong@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 14, 2022
• Study Start: April 21, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

CN (1)