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Postmenopausal Osteoporosis clinical trials

View clinical trials related to Postmenopausal Osteoporosis.

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NCT ID: NCT05346419 Completed - Clinical trials for Postmenopausal Osteoporosis

Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Osteoporosis is defined as a systemic disease of bone mineralization, characterized by a decrease in bone mineral density that causes bone fragility and increases the risk of fractures during menopause. Recently, a high prevalence of hypovitaminosis D has been found worldwide, which could trigger a state of secondary hyperparathyroidism that can worsen the state of postmenopausal patients with osteoporosis. An open-label, clinical trial was conducted in Mexican women with postmenopausal osteopenia-osteoporosis to determine the efficacy of the combined treatment with risedronate and high-dose vitamin D in improving bone mineral density, hyperparathyroidism, and hypovitaminosis D.

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: NCT05087030 Completed - Clinical trials for Postmenopausal Osteoporosis

Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis

Start date: September 21, 2021
Phase: Phase 3
Study type: Interventional

This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in participants with postmenopausal osteoporosis, in a comparative manner.

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: NCT05060380 Not yet recruiting - Osteoporosis Clinical Trials

Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Start date: June 1, 2025
Phase: N/A
Study type: Interventional

The aim of the 6 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in postmenopausal women with low bone mass.

NCT ID: NCT05010590 Active, not recruiting - Clinical trials for Postmenopausal Osteoporosis

Anabolic Therapy in Postmenopausal Osteoporosis

Start date: March 24, 2022
Phase: Phase 4
Study type: Interventional

In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.

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: NCT04934072 Completed - Clinical trials for Postmenopausal Osteoporosis

A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis

Start date: July 5, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate equivalent efficacy of FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO). Participants will be randomized at the beginning of the Double-blind Core Treatment Period (Baseline to Week 52) to receive either FKS518 or US-licensed Prolia on Day 1, and then every 26 weeks for up to 52 weeks. At the beginning of the Double-blind Transition Period (Week 52 to Week 78), participants who received US-licensed Prolia will be re-randomized to either continue receiving US-licensed Prolia every 26 weeks for up to 78 weeks, or switch to receive FKS518 every 26 weeks for up to 78 weeks. Participants who were randomized to receive FKS518 at the beginning of the Double-blind Core Treatment Period will continue to receive this treatment during the Double-blind Transition Period. For Marketing Authorization Application (MAA) in the EU and European Economic Area (EEA) only: The primary objective is to demonstrate equivalent efficacy and pharmacodynamics of the proposed biosimilar denosumab FKS518 to US-Prolia in women with PMO.

NCT ID: NCT04873960 Completed - Quality of Life Clinical Trials

Translation and Cross -Cultural Validation of ECOS-16 Questionnaire in Urdu Language

Start date: March 15, 2021
Phase:
Study type: Observational

Osteopenia is a clinical term to define the declined Bone Mineral Density (BMD) as per the normal reference values but not low enough to meet osteoporotic diagnostic criteria. A Dual-energy x-ray absorptiometry (DXA) bone scan is used to diagnose decreased BMD. Osteopenia is, as described by the World Health Organization (WHO), a score ranging from -1 to -2.5, whereas Osteoporosis is diagnosed with values less than - 2.5. The risk of a decrease in BMD doubles as a woman goes into Menopause. The objective of this study will be to determine the effects of Kinect-based virtual reality training on BMD, fracture risk, physical function and Quality of life in postmenopausal women with Osteopenia. The aim of the present study is to translate the ECOS-16 Questionnaire into Urdu Language along with validation of the translated versions by evaluating its validity and reliability in the Postmenopausal women of Pakistan with Osteopenia or Osteoporosis and understanding Urdu Language. No such study has been previously conducted in the Pakistan region which translates the specific questionnaire and follows the proper cross-culture adaptation protocol.

NCT ID: NCT04747392 Completed - Clinical trials for Postmenopausal Osteoporosis

Bioequivalence Study of SAL001 and FORSTEO in Healthy Chinese Adults

Start date: August 19, 2020
Phase: Phase 1
Study type: Interventional

This is a single-center, randomized, open label, single-dose, the original drug controlled, crossover design, two sequence, two periods, Phase Ⅰclinical study. 64 qualified subjects will be randomly assigned to two administration sequences (sequence A and sequence B) at the ratio of 1∶1, with 32 subjects in each sequence. Each period will be given subcutaneous injection once, and the washout period will be 72 hours, and each subject will be given subcutaneous injection twice. Sequence A: the test drug (SAL001) is injected in the first period, and the reference drug (FORSTEO) is injected in the second period. Sequence B: the reference drug (FORSTEO) is injected in the first period, and the test drug (SAL001) is injected in the second period. If the geometric mean ratio (GMR) 90% confidence interval of the major pharmacokinetic indexes (AUC0-t, Cmax) for SAL001 and FORSTEO is between 80.00% and 125.00%, the two drugs are considered to be bioequivalent.