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Osteoporosis, Postmenopausal clinical trials

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NCT ID: NCT06375668 Active, not recruiting - Clinical trials for Osteoporosis, Postmenopausal

The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women

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

Osteoporosis is a systemic condition characterized by low bone mass and altered bone tissue microarchitecture, with the resulting greater bone fragility leading to fractures. Osteoporosis develops as a result of genetic and environmental factors, with the patient's lifestyle playing an important role. Recent years saw an emergence of reports on the significance of the intestinal microbiota in the development of osteoporosis, thus new ways of modifying the composition and activity of microbiota have been sought, and the potential role of probiotics has been considered. Probiotics are defined as live microorganisms, which-when administered at appropriate doses-are beneficial to the host's health. Probiotics both modify the gut microbiota composition and directly affect the human body. Recently published clinical studies demonstrated that probiotics may facilitate osteoporosis treatment and prevention. The current randomized double-blind placebo-controlled study will assess the effect of a dietary intervention via oral supplementation of Lactobacillus plantarum and Lactobacillus paracasei in a population of Polish postmenopausal women on their bone mineral density assessed via bone densitometry-derived T-scores of the lumbar segment of the spine (L1-L4). Study subjects will take the provided probiotic formulation/placebo orally once daily for 12 months.

NCT ID: NCT05853354 Active, not recruiting - Clinical trials for Osteoporosis, Postmenopausal

Comparative Efficacy, Safety, PK, and Immunogenicity Study

Start date: April 5, 2023
Phase: Phase 3
Study type: Interventional

this comparative clinical study is designed to demonstrate that LY06006 and EU-Prolia have no clinically meaningful differences in clinical efficacy, pharmacodynamic (PD), safety, PK, and immunogenicity in postmenopausal women with osteoporosis.

NCT ID: NCT05395091 Active, not recruiting - Clinical trials for Osteoporosis, Postmenopausal

Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

ALVOBOND
Start date: August 23, 2022
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in postmenopausal women with osteoporosis.

NCT ID: NCT05332626 Active, not recruiting - Bone Loss Clinical Trials

Lactobacillus Acidophilus and Postmenopausal Osteoporosis Women

LaBon
Start date: February 1, 2022
Phase: N/A
Study type: Interventional

This study aims to evaluate the effect of Lactobacillus acidophilus supplementation on calcium status and bone densitometry in postmenopausal women in a randomized, double-blind placebo-controlled study.

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: NCT04338529 Active, not recruiting - Clinical trials for Postmenopausal Osteoporosis

Alendronate in an Weekly Effervescent Tablet Formulation Following Denosumab Discontinuation

BAD
Start date: April 1, 2020
Phase:
Study type: Observational

Discontinuation of denosumab results in a rebound response of bone turnover markers, which rise above baseline at 3 months and remain elevated until reaching again baseline levels approximately 30 months after the last dose. Bone mineral density (BMD) gains are also lost and BMD values reach original baseline values after 1-2 years off-treatment.For the above reasons, current literature recommends that patients who discontinue denosumab should continue to receive either intravenous (iv) or oral (peros) bisphosphonate therapy for some time. The study aims to investigate changes in the BMD of the lumbar spine 12 months after transitioning from denosumab to oral alendronate 70 mg in a weekly effervescent tablet formulation

NCT ID: NCT03931109 Active, not recruiting - Clinical trials for Osteoporosis, Postmenopausal

Circulating miRNA in Primary Hyperparathyroidism

Start date: September 7, 2018
Phase:
Study type: Observational [Patient Registry]

The goal of this study is to: 1. Analyze the expression levels of circulating (serum) miRNAs in primary hyperparathyroidism patients with and without osteoporosis, and patients with osteoporosis undergoing thyroidectomy, and to correlate with clinical markers of bone remodeling including biochemical and radiologic studies. 2. To evaluate serum miRNA levels after treatment with parathyroidectomy.

NCT ID: NCT03720886 Active, not recruiting - Clinical trials for Postmenopausal Osteoporosis

G56W1 in Women With Postmenopausal Osteoporosis

Start date: October 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study will assess the pharmacokinetics and safety and explore therapeutic effects with once-weekly recombinant human parathyroid hormone for injection ( 1-34 ) ( G56W1 ) in women with post-menopausal osteoporosis .The anticipated time on study treatment is 24 weeks, and the target sample size is 148 individuals.

NCT ID: NCT03692143 Active, not recruiting - Quality of Life Clinical Trials

Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP

Start date: January 1, 2017
Phase:
Study type: Observational

This study aimed to compare teriparatide treatments and PVPs, focusing on its effects on life qualities and effect/coast ratio and evaluate which method is better for patients.

NCT ID: NCT03623633 Active, not recruiting - Osteoporosis Clinical Trials

Comparative Antiresorptive Efficacy Discontinuation of Denosumab

Start date: November 30, 2018
Phase: Phase 4
Study type: Interventional

Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene. Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued. This study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.