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Osteoporosis clinical trials

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NCT ID: NCT06264609 Enrolling by invitation - Osteoporosis Clinical Trials

Precision Medicine Approach for Osteoporosis - Follow Up Study

Start date: February 1, 2024
Phase: Phase 4
Study type: Interventional

Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality. Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781Íž efforts are focused on addressing this particular problem. Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment.

NCT ID: NCT05981222 Enrolling by invitation - Osteoporosis Clinical Trials

Osteo Match Cages Versus PEEK Cages in Osteoporotic Patients

OMC
Start date: August 1, 2023
Phase:
Study type: Observational

This is a multicenter, prospective cohort study. The osteoporotic patients requiring posterior lumbar interbody fusion(LIF) with cages are prospectively enrolled and followed up. The patients undergoing LIF with the biomechanical-matched 3D-printed titanium cages (Osteo Match) are compared with those using routine PEEK cages. The hypothesis is that the use of Osteo Match cages can reduce the rate of cage subsidence and increase the rate of lumbar fusion in osteoporotic patients.

NCT ID: NCT04534166 Enrolling by invitation - Clinical trials for Healthcare; Risk Prediction; Diabetic Patients With Osteoporosis

A Model for Risk Prediction of Fracture in Diabetic Patients With Osteoporosis

Start date: July 1, 2012
Phase:
Study type: Observational [Patient Registry]

The fracture risk of diabetic patients proves to be higher than those without diabetesdue to thehyperglycemia, usage of diabetes drugs, the changes in insulin levels and excretion, and this risk begins as early as adolescence.Many factors may be related to bone metabolism in patients with diabetes, including demographic data (e.g. age, height, weight, gender), medical history (e.g. smoking, drinking, menopause) and examination (e.g. bone mineral density, blood routine), urine routine).However, most of existing methods are qualitative assessments and do not take the interactions of the physiological factors of humans into consideration. In addition, the fracture risk of diabetic patients with osteoporosis has not been further studied before. In order to investigate the effect of patients' physiological factors on fracture risk, in the paper, we used a hybrid model combining XGBoost with deep neural network to predict the fracture risk of diabetic patients with osteoporosis.

NCT ID: NCT04399421 Enrolling by invitation - Osteoporosis Clinical Trials

Pedicle Screw Fixation in Osteoporotic Lumbar Spine

PSFOLS
Start date: February 3, 2021
Phase:
Study type: Observational

This is a prospective, observational single-center study. The osteoporotic patients requiring pedicle screw fixation for lumbar degenerative diseases are prospectively enrolled and followed up. This study mainly focuses on the most common osteoporosis-related surgical complications, which are pedicle screw loosening and the failure of lumbar fusion. The global and local bone mineral density(BMD) are evaluated with DXA, vertebral CT Hounsfield units(HU) before the surgery. The mechanical strength of the bone mass within the screw trajectory is also measured with a customized device during the surgery. We explored the effect of BMD on the pedicle screw loosening rate and fusion rate. In addition, the patients undergoing lumbar fixation with conventional pedicle screws without the use of bone cement are compared with those undergoing the fixation augmented with bone cement. The objective is to offer more detailed clinical evidence to guide the use of pedicle screw augmentation techniques in osteoporotic patients.

NCT ID: NCT04086784 Enrolling by invitation - Osteoporosis Clinical Trials

3D-printed Porous Titanium Alloy Cages Versus PEEK Cages in Patients With Osteoporosis

3DCOP
Start date: January 15, 2020
Phase:
Study type: Observational

This is a prospective,observational single-center study. The osteoporotic patients requiring posterior lumbar interbody fusion(PLIF) with cages at the lowest fusion segment are prospectively enrolled and followed up. The patients undergoing PLIF with the 3D-printed porous titanium alloy cages are compared with those using PEEK cages. The hypothesis is that the use of 3D-printed porous titanium alloy cages can reduce the rate of pedicle screw loosening and increase the rate of lumbar fusion in osteoporotic patients.

NCT ID: NCT04085419 Enrolling by invitation - Osteoporosis Clinical Trials

Osteoporosis in Primary Hyperparathyroidism

Start date: May 8, 2019
Phase: Phase 4
Study type: Interventional

Investigators will prospectively include 40 postmenopausal women with secondary osteoporosis due to primary hyperparathyroidism who have refused surgery. Participants will be randomized in two groups and treated either with zoledronic acid 5 mg iv once a year or with denosumab 60 mg sc every 6 months. Investigators will compare the effect of both drugs on bone turnover markers and basic laboratory parameters after 3, 12 and 24 months of treatment, and on the bone mineral density after 12 and 24 months of treatment. All participants will take cholecalciferol 800 - 1000 IU daily.

NCT ID: NCT03994094 Enrolling by invitation - Osteoporosis Clinical Trials

Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures

Start date: June 12, 2019
Phase:
Study type: Observational

A specialized osteoporosis clinic has existed in our hospital since 2010. The descriptive retrospective analysis of patients included in this pathway was the subject of a first study on patients included between January 2010 and January 2011 and reported to the Congress of the French Society of Rheumatology (SFR) in December 2011, then a second study on patients included between January 2012 and December 2016, presented as an e-poster at the SFR Congress in December 2017 and in a poster at the American Society of Bone and Mineral Research Conference (ASBMR) in October 2018 and published in 2019 in Archives of Osteoporosis. The effectiveness specialized osteoporosis clinics is the subject of numerous publications. It therefore seems important to evaluate the effectiveness of our management, 3 years from the date of inclusion of patients in the osteoporosis clinic of our hospital.

NCT ID: NCT03534934 Enrolling by invitation - Osteoporosis Clinical Trials

CT-Based Modeling of Bone Micro-Architecture and Fracture-Risk in COPD

Start date: February 26, 2019
Phase: N/A
Study type: Interventional

The goal of this translational study is to establish a newly emerging CT-based tool for the characterization of changes in bone micro-architecture and assessment of their implications for fracture-risk in a population of COPD patients at risk for osteoporosis. The tool will be suitable and generalizable across emerging CT scanners from different vendors, and it will provide a more structurally-based assessment of osteoporosis and bone loss than is provided by simple bone density measures. The study will characterize the impact of different COPD-related factors on bone structure, and their implications for fracture-risk, leading to the development of a COPD-specific model for assessment of fracture-risk that will utilize patient-specific demographic, clinical and radiographic data, and CT BMD at the spine, as well as bone structural measures at the hip and/or ankle.

NCT ID: NCT03512743 Enrolling by invitation - Clinical trials for Postmenopausal Osteoporosis

Association of Serum Ferritin and Bone Mineral Density With Bone Metabolism in Chinese Healthy Postmenopausal Women

Start date: May 1, 2018
Phase:
Study type: Observational

Large amounts of experimental and animal evidence have confirmed that iron accumulation is associated with bone loss. However, it is still lack of the clinical studies relating iron accumulation to bone loss, especially in the pathological conditions during our Chinese. In this study, the investigators aim to assess the association between the levels of serum ferritin and bone mineral density in Chinese healthy postmenopausal women.

NCT ID: NCT03475719 Enrolling by invitation - Clinical trials for Osteoporosis, Postmenopausal

A Clinical Trial to Evaluate the Safety and Pharmacokinetic

Start date: January 11, 2018
Phase: Phase 1
Study type: Interventional

A phase 1 clinical trail to evaluate the safety and pharmacokinetic characteristic after administration of fixed-dose combination or loose combination of HUG186 in healthy adult male or menopausal female volunteers