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Efficacy and Safety of JMT103 in the Treatment of Postmenopausal Women With Osteoporosis | Clinical Trials | Clareo Health

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

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

NCT05278338•Shanghai JMT-Bio Inc.

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

50 - 85 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Postmenopausal women, capable of autonomous action, aged 50-85 years (inclusive);
•2. 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;
•3. 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;
•4. 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;
•5. Be able to be fully informed and sign an informed consent form.

Exclusion Criteria

•1. A history of fractures of more than 2 vertebral bodies;
•2. 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;
•3. Currently suffering from hyperparathyroidism or hypoparathyroidism;
•4. 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;
•5. Rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus and other rheumatic immune diseases;
•6. Malabsorption syndrome: Malabsorption syndrome or various gastrointestinal diseases related to malabsorption, such as Crohn's disease and chronic pancreatitis;
•7. 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;
•8. 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);
•9. 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%;
•10. Active bacterial or fungal infection requiring systemic treatment within 7 days before randomization;
+19 more criteria

Locations (1)

The Second Hospital of Jilin University

Changchun, Jilin, China

Key Dates

Start Date

April 21, 2022

Primary Completion Date

December 31, 2023

Completion Date

March 31, 2024

Last Updated

July 18, 2022

Enrollment

200

ESTIMATED participants

Conditions

Postmenopausal Osteoporosis

Interventions

JMT103

DRUG

Denosumab

DRUG

Placebo

DRUG

Contacts

Rong Du

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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Exclusion Criteria

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