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Osteoporosis 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: NCT06287502 Active, not recruiting - Osteoporosis Clinical Trials

Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis

Start date: September 9, 2022
Phase: N/A
Study type: Interventional

This is a prospective parallel group, double-blinded randomized controlled trial. Subjects are randomized into two groups - the intervention group and waitlist control group. Subjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy β-methylbutyrate (HMB). The intervention group would first receive the intervention during the 12-week study period. Meanwhile, the waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention.

NCT ID: NCT05889598 Active, not recruiting - Osteoarthritis Clinical Trials

Resistance Exercise Training to Improve Bone and Articular Cartilage Health in Women

REPROOF
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Osteoarthritis (degenerative joint disease) and osteoporosis (weak and fragile bones) are common conditions, particularly in women after menopause, and become even more common as we get older. Aging is also associated with sarcopenia, the progressive loss of muscle strength and mass with age. In this three-arm study, the effect of resistance exercise programs with different parameters (such as velocity and load) on various outcomes, including structural changes (bone mineral density, cartilage composition, muscle size), physical function, and biomarkers will be compared.

NCT ID: NCT05714787 Active, not recruiting - Osteoporosis Clinical Trials

Opportunistic Screening for Osteoporotic Vertebral Fractures in Patients With Diffuse Interstitial Lung Disease

Start date: January 23, 2017
Phase:
Study type: Observational

It is well known that some chronic respiratory pathologies such as asthma or chronic obstructive pulmonary disease (COPD) are associated with an increased risk of osteoporosis, due to the pathology itself and the therapies implemented (per-os or inhaled corticosteroids). Osteoporosis leads to an increased risk of fragility fracture, with an increased morbidity and mortality associated with severe fractures such as vertebral fractures. Also, osteoporotic vertebral fractures often occur at the thoracolumbar hinge, resulting in worsening of the thoracic kyphosis. However, to the best of our knowledge, the prevalence of osteoporotic vertebral fractures measured by CT scan in patients with interstitial lung disease (ILD) is not known. For these patients who already have impaired respiratory function, the appearance of vertebral fractures could impact their management and worsen their prognosis (additional restrictive syndrome, difficulties in analgesics management because of respiratory contraindications, difficulties in wearing a corset, etc...). In this context, it appears interesting to define the prevalence of osteoporosis and osteoporotic vertebral fractures at the thoracic spine and the thoraco-lumbar hinge in a population of patients followed for ILD. So, the main objective of this study is to describe the prevalence of vertebral osteoporotic fractures in an overall cohort of patients with ILD.

NCT ID: NCT05673837 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 1

the Type ONe dIabetic Bone Collaboration Study

TONICS
Start date: December 10, 2021
Phase:
Study type: Observational

In this cross-sectional clinical study, we will examine the bones of 111 Type 1 Diabetes (T1D) patients and 37 age-matched healthy controls with the aim of describing a T1D Bone Phenotype. The main Objectives of the study is a) to determine if the material properties of the bones are affected in diabetic bone disease and b) to determine if the mitochondrial function in osteoclasts and osteoblasts is impaired in T1D. Secondary end points are c) to establishment of the T1D bone phenotype and d) to investigate if mitochondrial dysfunction in T1D bone cells correlates to changes in gene expression, gene activity, bone remodelling, bone density, microarchitecture, geometry and material properties. Furthermore, in terms of contributing to knowledge on etiology and pathology of type one diabetic bone disease, we will study the predictory value of muscle mass in T1D patients and controls, as well as other characteristics such as heart rate variability (HRV) and AGE content. Furthermore, we will study the epidemiology of osteoporosis and fractures in Danish T1D patients. To assess the material properties of the bones, we will measure the bone mass density (BMD), use High Resolution peripheral Quantitative Computed Tomography (HRpQCT) for assessment of the microarchitecture and finite element analysis of bone strength, and by microindentation, we will obtain direct measures of the strength of the cortical bone of the tibia. Further we will measure bone turnover markers and circulating microRNA and in a subgroup of participants (24 T1D, 12 controls) bone samples will be retrieved for examination of bone histomorphometry (structural and static parameters) and cell samples from blood and bone marrow will be used for in vitro experiments focused on cell differentiation mitochondrial function, as hyperglycemia may affect mitochondrial function. Finally measures of some possible predictors of bone fragility in subjects with T1D are examined (sarcopenia, skin advanced glycation end products (AGE) content, autonomic neuropathy)

NCT ID: NCT05666310 Active, not recruiting - Osteoporosis Clinical Trials

Muscle Impact of Treating Osteoporosis

MITO
Start date: February 14, 2023
Phase: Phase 4
Study type: Interventional

Osteosarcopenia is a geriatric musculoskeletal syndrome characterized by co-existence of osteoporosis and sarcopenia (low skeletal muscle mass, strength, and/or functional capacity). There is strong evidence of overlap between the pathophysiology of osteoporosis and sarcopenia (muscle-bone crosstalk). This research plan will further explore the relationship between bone and muscle, and provide new information about effect of osteoporosis medications on muscle health in older adults who are under treatment for 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: NCT05369013 Active, not recruiting - Osteoporosis Clinical Trials

Study and Follow-up of the Clinical Effectiveness and Comparative Safety of Biosimilar Teriparatide in the Management of Postmenopausal or Senile.

ESECTO
Start date: June 15, 2021
Phase:
Study type: Observational

Non-interventional observational prospective follow-up study of cohorts of patients with Previous diagnosis of Osteoporosis with high risk of fractures, with/without previous fractures and treatment with bone formers (biosimilar or original Teriparatide), who meet all the inclusion criteria and exclusion, with prior information and signing of prior informed consent documents.

NCT ID: NCT05352516 Active, not recruiting - Postmenopausal Clinical Trials

A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture

Start date: June 17, 2022
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, international multicentre, parallel-controlled phase III clinical study. The study plans to enroll 478 postmenopausal women with osteoporosis at high risk of fracture, whom will be randomized at 1:1 to either the experiment group (HLX14) or the control group (Prolia®) based on stratification factors (BMI (< 25, 25-30, > 30) and geographic region (Asian or non-Asian)). The study includes screening period (28 days), treatment period (total 546 days, contain treatment period 1: D1-D364, treatment period 2: D365-D546), and an end-of-study visit (D547).

NCT ID: NCT05348694 Active, not recruiting - Clinical trials for Glucose Metabolism Disorders

OsteoPreP: Food Supplements for Postmenopausal Bone Health

OsteoPreP
Start date: May 1, 2022
Phase: Phase 4
Study type: Interventional

To evaluate the effect of 12 months of supplementation with a probiotic (probiotic plus prebiotic; 2 capsules per day) on relative change (%) in total volumetric bone density (measured using high resolution peripheral quantitative computed tomography [HR-pQCT]) of the distal tibia.