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Osteoporosis clinical trials

View clinical trials related to Osteoporosis.

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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: NCT04960033 Completed - Clinical trials for Osteoporosis Fracture

Evaluating Fracture Risk Assessment Tools (FRAX) From Different Regions in Central South Chinese Postmenopausal Women

Start date: September 1, 2017
Phase:
Study type: Observational [Patient Registry]

We evaluated fracture risk assessment tools (FRAXs) from different regions in Chinese postmenopausal women.

NCT ID: NCT04954417 Recruiting - Osteoporosis Clinical Trials

A Study on Vertebral Bone Strength by Micro-CT-Like Image

Start date: May 1, 2021
Phase:
Study type: Observational

In this study, we use conditional generation adversarial network to enhance the resolution of MSCT images and obtain micro-CT-like images. Based on this, we measure the bone structure indexes of micro-CT-like images and analyzed the correlation between bone structure and bio-mechanical indexes.

NCT ID: NCT04950283 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

MR-based Characterization of Bone Marrow in Its Relevance to Skeletal Disease in Patients With Diabetes

Start date: July 7, 2021
Phase:
Study type: Observational

For a long time, no direct connection was seen between the two common diseases diabetes mellitus and osteoporosis. However, as more and more younger people are affected by obesity, develop type 2 diabetes mellitus and suffer osteoporotic fractures, the question of a connection between these clinical pictures has now arisen. Modern magnetic resonance imaging and spectroscopy techniques allow detailed and non-invasive characterization of bone marrow in different body regions. Low body weight (BMI<20kg/m²) has been shown to be associated with decreased bone density, while obesity has long been associated with high cortical bone mass - the idea of bone health. It has now been proven that obesity also has a negative effect on bone structure. Here, it is not only BMI that is crucial, but also the localization of fat tissue in the body. Visceral fat has a directly damaging effect on bone microarchitecture through dysregulated production and release of cytokines and adipokines. Thus, it has been shown that both type 1 and type 2 diabetic patients have a decreased rate of bone remodeling and very obese patients with type 2 diabetes have an increased risk of fracture. It must be concluded that body weight, or BMI, cannot be the sole measure for estimating bone health. Thus, type 2 diabetes shows reduced bone remodeling with normal or slightly increased bone density, but inferior stability. This means that type 2 diabetes is associated with an increased risk of osteoporotic fracture, even when bone density measurements are unremarkable. Loss of trabecular bone structure in red (hematopoietic) bone marrow is also characterized by increasing infiltration of the bone marrow space with fat cells (bone marrow adipose tissue). In contrast, the yellow bone marrow, which is mainly present in the diaphysis of tabular bones, has particularly large amounts of fat incorporated into the reticulum cells. For a long time, only the role of "placeholder" was attributed to these fat cells, but it has been shown that they interact with other cells via the production of autocrine, paracrine and endocrine hormones and cytokines, or adipokines, and are thus related to the metabolic state of the entire body. A basic assumption here is that the amount of unsaturated fatty acids in the adipose bone marrow is an important and functional marker for different types of adipocytes. It has been shown that 3 individuals with poorer insulin sensitivity have more unsaturated fatty acids in yellow bone marrow. Thus, the concept of different types of adipocytes in the bone marrow, with their inherent different fatty acid composition could serve to reconcile the at first glance counterintuitive physiological regulation of bone marrow fat and its response to metabolic perturbations. In order to show whether and how the composition of the yellow (unsaturated fatty acids) and red (bone marrow adipose tissue) bone marrow differs in healthy individuals, individuals with impaired insulin sensitivity in different age groups and patients with type 2 diabetes, and whether this can be used to detect early changes in the bone matrix with regard to bone density, the proportion of bone marrow adipose tissue in the red bone marrow at different locations in the skeleton will be quantified by means of chemical-shift-selective MRI sequences as well as the composition of bone marrow fat in the yellow bone marrow with regard to the proportions of monounsaturated and polyunsaturated fatty acids by means of volume-selective MRS. A total of 96 healthy volunteers (48 each male and female) aged 25 to 75 years and with body mass index between 18.5 and 35 kg/m² will be included. In addition, 24 patients (12female/12male) with type 2 diabetes will be recruited. After magnetic resonance examination, anthropometric and metabolic characterization (oral glucose tolerance test) will take place.

NCT ID: NCT04947722 Recruiting - Osteoporosis Clinical Trials

The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Hip fractures occur nearly twice as often for older adults residing in long-term care as they do in older adults of a similar age still living in other settings. Hip fractures are the leading cause of hospitalization and often result in loss of independence, problems with walking and sometimes death. To address this problem the PREVENT (Person-centered Routine Fracture PrEVENTion in LTC) program was designed for use in long-term care homes. PREVENT uses a tool ("fracture risk calculator") based on a residents electronic health record to capture who is most at risk of fracture due to osteoporosis and falls. The program then trains the health care team including doctors, pharmacists and nurses on the latest recommendations on how to best assist residents and their families in making treatment decisions. The healthcare teams are also given tools that help them stay on track such as templates for ordering medications, strategies to reduce falls and fractures and making care plans. The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program (intervention group) and some homes to usual care (control group) and comparing the results.

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: NCT04936984 Completed - Osteoporosis Clinical Trials

Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.

Start date: November 16, 2020
Phase: Phase 1
Study type: Interventional

A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.

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: NCT04931602 Recruiting - Osteoporosis Clinical Trials

Determining Feasibility of a Model of Care for Secondary Fracture Prevention

Start date: July 1, 2021
Phase:
Study type: Observational

Osteoporosis is a disorder of low bone mass and micro-architectural deterioration resulting in decreased mechanical strength and increased susceptibility to fractures even after minimal trauma. These 'minimal trauma fractures' (also known as 'osteoporotic', 'low trauma' or 'fragility' fractures) are the hallmark of a chronic and disabling disease that affects both men and women worldwide. On statistical grounds, more than 50 % of postmenopausal women and 30 % of men over the age of 60 years will suffer at least one minimal trauma fracture during their remaining lifetime. Any osteoporotic fracture predisposes to further fractures, significant morbidity and premature death. Thus, following a first minimal trauma fracture both men and women have a two- to threefold increased risk of subsequent fracture. This study aims to determine feasibility of evaluating different models of care through a structured multidisciplinary path tailored to identify, assess and treat hip fracture patients in an effective timely manner that are at high risk of subsequent fracture (Type A model) and to compare its effectiveness and feasibility with a type B, C & D model as proposed by Ganda et al at the Aga Khan University, with collaboration of the departments of Orthopaedics, Chemical Pathology, Family Medicine and Internal Medicine.

NCT ID: NCT04903847 Recruiting - Obesity Clinical Trials

Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil

AVERTAS-2
Start date: February 2, 2021
Phase: Phase 4
Study type: Interventional

Randomized controlled parallel open-label study in persons living with HIV. The aim is to study weight changes in patients switching from a dolutegravir and tenofovir disoproxil containing regimen to either a dolutegravir or tenofovir disoproxil free regimen.