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Osteoporosis clinical trials

View clinical trials related to Osteoporosis.

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NCT ID: NCT05775094 Recruiting - Multiple Myeloma Clinical Trials

A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis

Start date: March 7, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to measure the effect of romosozumab on bone formation and breakdown (resorption) and determine if romosozumab is a safe treatment for osteoporosis and myeloma-related bone disease (MBD) in postmenopausal people with multiple myeloma (MM).

NCT ID: NCT05762549 Recruiting - Osteoporosis Clinical Trials

Prevalence of Hidden Hypercortisolism in Osteoporosis

OSTCOR
Start date: May 26, 2022
Phase:
Study type: Observational

The goals of this observational study are the following: i) to assess the prevalence of hidden hypercortisolism (HidHyCo) in a sample of osteoporotic patients; ii) to compare the clinical characteristics between osteoporotic/osteopenic patients with HidHyCo and those without HidHyCo in order to determine the clinical characteristics more frequently associated with the HidHyCo presence in the osteoporotic population and to identify those osteoporotic patients worthy of HidHyCo screening. In all patients who have been included in the study and who have given the informed consent to participate in the study we will perform 1 mg overnight dexamethasone suppression test (F-1mgDST). In all subjects with F-1mgDST >1.8 mcg/dL, cortisol levels after two-day low dose (2 mg/day) dexamethasone suppression test (F-2mgx2dDST) will be measured. Patients with F-2mgx2dDST above >1.8 mcg/dL will be considered affected with HidHyCo and will be managed following the available guidelines for hypercortisolism. The HidHyCo could be present in a not negligible percentage of osteopenic/osteoporotic patients. In these patients, osteoporosis and, if present, other comorbidities (i.e. hypertension and/or diabetes) can improve by the surgical resection of the adrenal or pituitary adenoma if feasible, or by the use of drugs able to modulate cortisol secretion or glucocorticoid sensitivity.

NCT ID: NCT05732870 Recruiting - Osteoarthritis Clinical Trials

OSTEOMICS: Identifying Regulators of Bone Homeostasis

OSTEOMICS
Start date: January 12, 2023
Phase:
Study type: Observational

Diseases of bone associated with ageing, including osteoporosis (OP) and osteoarthritis (OA), reduce bone mass, bone strength and joint integrity. Current non-surgical approaches are limited to pharmaceutical agents that are not disease modifying and have poor patient tolerability due to side effect profiles. Developing a fundamental understanding of cellular bone homeostasis, including how key cell types affect tissue health, and offering novel therapeutic targets for prevention of bone disease is therefore essential. This is the focus of OSTEOMICS. A number of factors have been linked to increased risk of bone disease, including genetic predisposition, diet, smoking, ageing, autoimmune disorders and endocrine disorders. In our study, we will recruit patients undergoing elective and non-elective orthopaedic surgery and obtain surgical bone waste for analysis. This will capture a cohort of patients with bone disorders like OP and OA, in addition to patients without overt clinical bone disease. We will study the relationship between the molecular biology of bone cells, bone structure, genetics (DNA) and environmental factors with the aim of identifying and validating novel therapeutic targets. We will leverage modern single cell technologies to understand the diversity of cell types found in bone. These technologies have now led to the characterisation of virtually every tissue in the body, however bone and bone-adjacent tissues are massively underrepresented due to the anatomical location and underlying technical challenges. Early protocols to demineralise bone and perform single cell profiling have now been developed. We will systematically scale up these efforts to observe how genetic variation at the population level leads to alterations in bone structure and quality. Over the next 10 years, we will generate data to comprehensively characterise bone across health and disease, use machine learning to drive analysis, and experimentally validate hypotheses - which will ultimately contribute to developing the next generation of therapeutic agents.

NCT ID: NCT05712252 Recruiting - Frailty Clinical Trials

Risk Factors for Fall and Fracture

Start date: February 1, 2023
Phase:
Study type: Observational [Patient Registry]

This project aims to improve the global outcome for an aging individual after a traumatic fall, through identifying conditions contributing to a fall and promoting recovery and rehabilitation. Through better understanding 'falling phenotype', the ultimate aim is to prevent future complications, as well as new falls and fractures in the growing older population.

NCT ID: NCT05688969 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Mechanisms of Anabolic Osteoporosis Therapy

Start date: June 14, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.

NCT ID: NCT05655013 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2)

Start date: May 10, 2023
Phase: Phase 4
Study type: Interventional

The aims of ZOLARMAB2 are fourfold. First, the investigators want to investigate if multiple infusions of zoledronate can prevent the rebound activation of bone turnover and the subsequent bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronate at fixed time-points after the last injection of denosumab or when bone turnover is increased. Second, the investigators want to investigate if bone loss will resume after controlling the rebound activation of bone turnover during the first year after denosumab discontinuation and if this can be prevented by yearly infusions of zoledronate. Third, the investigators want to investigate the underlying pathophysiological mechanisms by investigating biochemical markers, osteoclast and osteoblast activation signals in the bone and bone marrow, and the pool of preosteoclasts/mature osteoclasts before and after treatment with zoledronate. Fourth, the investigators want to investigate the effect of denosumab discontinuation on muscle mass and muscle strength and on insulin sensitivity.

NCT ID: NCT05642143 Recruiting - Type 2 Diabetes Clinical Trials

Deep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy

Start date: February 24, 2023
Phase:
Study type: Observational

Objectives: The goal of this cross sectional clinical trial is to examine the phenotype of bone disease in type 2 diabetes.The main aims are to: 1. Compare bone microarchitecture, bone biomechanical competence, and bone turnover markers as well as postural control in T2D patients with and without fractures. 2. Examine how autonomic and peripheral neuropathy affects bone microarchitecture, bone material strength and bone turnover markers as well as postural control in T2D. Methods: The trial is of cross-sectional design and consists of examinations including - Blood samples to analyze bone markers, glycemic state i.e. - Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density, t-score and bone structure. - Microindentation to evaluate bone material strength - Skin autofluorescence to measure levels of advanced glycation endproducts (AGEs) in the skin - Assesment of nerve function (peripheral and autonomic) - Assesment of postural control, muscle strength and gait Participants: A total of 300 type 2 diabetes patients divided to three groups: - 160 with no history of fractures or diabetic neuropathy - 100 with a history of fracture(s) - 40 with autonomic neuropathy or severe peripheral neuropathy

NCT ID: NCT05630768 Recruiting - Clinical trials for Postmenopausal Osteoporosis

Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women

Start date: January 3, 2023
Phase: Phase 4
Study type: Interventional

To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year

NCT ID: NCT05614778 Recruiting - Osteoporosis Clinical Trials

Study to Investigate the Efficacy and Safety After Administration of Daewoong Zoledronic Acid for the Purpose of Treatment or Prevention of Osteoporosis

Start date: February 28, 2022
Phase:
Study type: Observational

This study is a non-interventional observational study. On the baseline (Visit 1), we collect demographic data from all participating subjects according to their daily medical conditions, prescribe drugs and collect validity and safety data according to the research plan in Visit 1 and Visit 2. In addition, we collect data by application on subject's self-awareness symptoms and subject's questionnaire for medical outcome short form health survey (SF-36) every day from the baseline for 4 days.

NCT ID: NCT05606510 Recruiting - Back Pain Clinical Trials

The Effects of Mindful Exercise on Back Pain in Older Patients With Primary Osteoporosis

Start date: February 16, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized control trial is to determine the effects of a mindful exercise program on physical (back pain and balance) and psychological (mindfulness, kinesiophobia, anxiety and depression) consequences of primary osteoporosis in older patients. The main questions it aims to answer are: - What are the levels of pain, balance, mindfulness, kinesiophobia, anxiety and depression in older patients with primary osteoporosis? - Are there differences in pain, balance, mindfulness, kinesiophobia, anxiety and depression according to sociodemographic-clinical characteristics of the patients? - Are there differences in pain, balance, mindfulness, kinesiophobia, anxiety and depression between the intervention (mindful exercise) and control (usual care) groups of older patients with primary osteoporosis? 128 participants who meet the criteria will be recruited from the pain department of a Tertiary A level provincial Traditional Chinese Medicine hospital in Mainland China, and randomly assigned to the intervention group or control group. All patients in both groups will receive usual care, including routine medicine and nursing care. The study will last for 12 weeks (one-week training in hospital and 11-week on-line sessions at home) and 4-week follow up. Patients in the intervention group will receive a group-based mindful exercise which will be conducted 5 times per week, 30 minutes per session, and co-led by a mindfulness-trained main researcher and a professional exercise specialist for the first week (week 1) hospitalization. When they discharge, on-line sessions (week 2-12) will be conducted by the main researcher from Monday to Friday. Patients and primary caregivers will be taught how to use 'Tencent meet' software. Upon discharge, a WeChat group will be set up to notify the exercise time and send the links for the online sessions. Those in the control group will received routine medicine and nursing care as usual, and only be taught on the hospital-recommended movements (physical stretching) and encouraged to do it at home on their own. All the variables (pain, mindfulness, kinesiophobia, anxiety and depression) and the TUG test (balance) will be measured at the following time point: baseline (Time 1), week 4 (Time 2), week 8 (Time 3), week 12 (Time 4, immediately post-intervention) and week 16 (Time 5, 4 weeks after the intervention) for the two groups of patients. The study will obtain ethical clearance from the study setting, as well as written consent from the participants. Descriptive statistics will be computed for all variables. Normality and homogeneity of the variances will be tested using the Shapiro-Wilk and Levene tests, respectively. The data will be analyzed using mixed-model analysis of variance to test the main and interaction effects of group (independent factor) and time (repeated-measures factor) on the dependent variables. The findings of the study would certainly have implications for the treatment of older patients with primary osteoporosis, especially non-pharmacological treatment.