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Osteoporosis, Postmenopausal clinical trials

View clinical trials related to Osteoporosis, Postmenopausal.

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NCT ID: NCT05419427 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis

Start date: November 11, 2021
Phase: Phase 3
Study type: Interventional

Denosumab of Intas is biosimilar denosumab candidate under development by Intas Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian drug licensing authority- Drug Controller General (India) for marketing in Indian population since 2018.As per regulatory requirement, a comparative clinical study to establish Pharmacokinetic, Pharmacodynamic and Immunogenicity equivalence is required to conclude therapeutic equivalence to obtain marketing authorization of a biosimilar investigational product. This is a multicenter, randomized, double-blind, active controlled study in approximately 552postmenopausal women with osteoporosis. An extension of the study is planned after completion of the initial 1 year of treatment. This extension is with the objective of submitting data on safety, and Immunogenicity, after switching of Prolia treatment arm to either Prolia or Intas denosumab for 6 months. This switching data is applicable only for FDA submission. Only patients who have undergone PK assessment will be eligible for the extension phase.

NCT ID: NCT05405725 Recruiting - Clinical trials for Postmenopausal Osteoporosis

A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®

Start date: July 4, 2022
Phase: Phase 3
Study type: Interventional

This is a phase 3 Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women with Osteoporosis

NCT ID: NCT05328154 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

MAGnesium Effect With ANtiosteoporotic Drugs

MAGELLAN
Start date: June 28, 2022
Phase: Phase 2
Study type: Interventional

Randomized pilot clinical trial to demonstrate superiority of bisphosphonate-magnesium combination over bisphosphonates alone in postmenopausal osteoporosis in slowing bone remodeling as assessed by C-terminal telopeptide of bone collagen type 1 (CTX) dosage.

NCT ID: NCT05278338 Recruiting - Clinical trials for Postmenopausal Osteoporosis

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

Start date: April 21, 2022
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT05228262 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

VASCO
Start date: February 15, 2022
Phase: N/A
Study type: Interventional

This study aims to follow a cohort of osteoporotic patients treated with anti-osteoporotic drugs and to evaluate the impact of these treatments on the osteoporosis-cardiovascular-sarcopenia triad and on pain.

NCT ID: NCT05060406 Recruiting - Clinical trials for Postmenopausal Osteoporosis

A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture

Start date: June 30, 2019
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, double-blind, placebo-controlled phase III clinical study will be conducted to evaluate the efficacy and safety of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for fracture, as well as an exploratory population pharmacokinetic analysis of LY06006.

NCT ID: NCT05058976 Recruiting - Osteoporosis Clinical Trials

Romosozumab Use to Build Skeletal Integrity

RUBI
Start date: September 15, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to find out if one year of romosozumab (Evenity®), a monthly injection given in the arm under the skin, prior to an infusion of zoledronic acid Reclast®, works to treat bone loss and prevent it from worsening in older women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.

NCT ID: NCT04964388 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effect of GLP-1 Receptor Agonists on Trabecular Bone Score

Start date: November 9, 2021
Phase: Phase 2
Study type: Interventional

This study will help determine the effect of Glucagon Like Peptide-1 (GLP-1)receptor agonists on bone strength in postmenopausal women with type 2 diabetes mellitus (T2DM)

NCT ID: NCT04940845 Recruiting - Clinical trials for Postmenopausal Osteoporosis

Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults

Start date: July 26, 2021
Phase: Phase 1
Study type: Interventional

A randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of HS-20090-2 60mg#1ml#and Prolia® in healthy adults.

NCT ID: NCT04591275 Recruiting - Clinical trials for Postmenopausal Osteoporosis

Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .

Start date: March 31, 2021
Phase: Phase 3
Study type: Interventional

evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)