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Osteoporosis clinical trials

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NCT ID: NCT03970902 Completed - Clinical trials for Postmenopausal Osteoporosis

Quality of Life in Postmenopausal Women With Osteoporosis

Start date: July 1, 2019
Phase:
Study type: Observational [Patient Registry]

The researchers will evaluate the effectiveness of a complex intervention composed of multiple actions targeting primary care healthcare workers and postmenopausal women with osteoporosis by means of a quasi-experimental design in the form of a cluster-controlled trial with clustering at family physician level. The study has 2 study arms. In one arm, osteoporosis stakeholders receive a complex intervention (Integrated Osteoporosis Care(IOC)). The second study arm serves as control and receives care as usual. The complex intervention is composed of - education and provision of educational material for all stakeholders in primary osteoporosis care (patients, family physicians, nurse-educators, physiotherapists, dietitians, pharmacists and if present patient's informal caregivers) - patient self-management support by primary care osteoporosis stakeholders - the construction of a primary care osteoporosis treatment guideline and care pathway Effectiveness will be measured by questionnaires and data from the (Electronic Medical Record)EMR and IMA-database, in patients and family physicians. Effects measured in family physicians are: - Identification failure rate - Percentage of family physicians correctly implementing the osteoporosis treatment guideline - Proportion of patients treated correctly as stated in the osteoporosis treatment guideline - Proportion of family physicians correctly registering osteoporosis related information in the EMR - Intensity of collaborative practices - Knowledge of osteoporosis management and treatment Effects measured in patients are: - Medication Possession Ratio(MPR) (Primary outcome) - Health literacy - Self-management efficacy - Self-reported treatment adherence - Self-reported nutritional intake - Intensity of integrated osteoporosis care - Patient satisfaction with integrated osteoporosis care - HRQoL - Functional independence (Activities of Daily Living - ADL) - Patient resource use The study elapse time is 18 months. Participating family physicians will receive postgraduate education and start to include patients during consultations in their doctor's office. The inclusion period is 6 months, patients eligible for participation are non-institutionalized postmenopausal women with a diagnosis of osteoporosis who are able to give informed consent. The follow-up period for patients is 12 months. Follow-up period for family physicians is 18 months.

NCT ID: NCT03966261 Terminated - Healthy Clinical Trials

The Role of Incretins in Bone Remodeling in Humans

INCREMOS
Start date: March 10, 2020
Phase:
Study type: Observational

The role of incretins (GIP and GLP-1) on cells and bone tissue has been shown in cellular and animal studies. In humans, the role of these hormones is mainly studied in the pathophysiology of diabetes, their effect on bone is unknown. The serum incretin concentration is low and increases rapidly after a meal. This increase is brief, incretins being rapidly degraded by dipeptidylpeptidase 4 (DPP-4). The dosage of these hormones is complex and the basal "normal" serum concentrations and after feeding in healthy subjects are unknown. Before any study on the effect of incretins on bone remodeling in humans, it is necessary to establish physiological concentrations of incretins in healthy subjects. The aim of this study is to estimate physiological concentrations of incretins in healthy subject.

NCT ID: NCT03960554 Terminated - Osteoporosis Clinical Trials

The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients

ProliaKTx
Start date: January 16, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2 Multi-Center Clinical Trial (safety and effectiveness trial) in 60 patients (40 denosumab; 20 placebo) who have had a kidney transplant for 12-months or longer with more than 30% of kidney function. The investigators will test whether denosumab safely improves bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) and improves bone strength by high resolution peripheral quantitative computed tomography (HR-pQCT) in the subset of patients recruited at Columbia University Irving Medical Center. These data will inform the development and execution of a larger trial to test if denosumab prevents fractures in kidney transplant recipients.

NCT ID: NCT03959995 Completed - Clinical trials for Osteopenia, Osteoporosis

Effects of Physical Exercise on Postmenopausal Risk Factors in Women With Osteopenia

ACTLIFE
Start date: January 15, 2019
Phase: N/A
Study type: Interventional

Menopause usually have a serious impact on a woman's life, associated with negative consequences for health and quality of life. Early preventive assessments are very difficult to implement due to the complex hormone-deficiency-induced effects on a large variety of organs and systems with estrogen receptors. In fact, only a few types of interventions have the potential to comprehensively improve the various risk factors and complaints of the menopausal transition. In detail, however, not every form of exercise training or every training protocol is effective for exerting positive effects on selected risk factors. In particular, the training concept for addressing musculoskeletal or cardio-metabolic risk factors differ fundamentally. In several studies, we confirmed the effect of different complex training programs on risk factors of different postmenopausal female cohorts with special consideration of osteoporotic aspects. The training programs applied in this context were characterized by the consistent implementation of recognized training principles and an in general exercise intensity-oriented approach. Recent studies confirmed the effectiveness of this proceeding for women with relevant postmenopausal risk factors including low bone strength. However, the crucial issue of the most effective, feasible and easily customizable training protocol for addressing postmenopausal risk factors remains to be answered, taking into account that the majority of exercise programs were realized in an ambulatory group setting. The aim of the study will be to evaluate the effects of an optimized physical training on risk factors and complaints of (early) postmenopausal women with special consideration of the osseous fracture risk. Note (05.06.2020): Of importance, the intervention has to be cancelled due to COVID-19 lockdown in March 2020 after 13 months of intervention.

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: NCT03930992 Completed - Clinical trials for Secondary Osteoporosis

Efficacy of Zoledronic Acid + Colaren vs Zoledronic Acid + Conventional Treatment for Osteoporosis in HIV+ and HIV- Men

OSZCO
Start date: April 17, 2019
Phase: Phase 3
Study type: Interventional

Clinical trial to assess the effectiveness of the supplement Colaren® associated with zoledronic acid 4mg/annually in the treatment of osteoporosis secondary, compared to standard treatment plus zoledronic acid 4mg/annually. The standard treatment will include 1gr of calcium/day and vitamin D supplement. In both cases, vitamin D levels will be determinated, which should remain at more than 30 ng/mL. Including men with osteoporosis secondary to HIV and men with osteoporosis secondary to any other cause (HIV negative). Vitamin D levels, bone densitometry and markers of metabolism, bone formation and bone resorption will be assessment. The all parameters above will be assessed basally (before the start of treatment), after starting the treatment, an assessment will be made at 12 weeks where vitamin D levels and bone markers will be measured. Meanwhile, at week 24 assess only vitamin D levels; and finally, at week 52 all parameters mentioned above will be measured.

NCT ID: NCT03930758 Completed - Clinical trials for Diabetes Mellitus, Type 2

Preventing Diabetic Osteoporosis With Exercise

DIABETICBONE
Start date: October 8, 2009
Phase: N/A
Study type: Interventional

The two specific aims of the study were to determine whether: 1. Greater mechanical loading of downhill exercise will increase the osteogenic index (ratio between CICP, the marker of bone formation (c-terminal propeptide of type I collagen, and CTX, the marker of bone resorption (c terminal telopeptide of type I collagen)) to a greater extent than uphill exercise that provides lower ground-reaction force; 2. Exercise after the meals will induce greater osteogenic response than exercise pefore the meals as it is known that meal eating during daytime inhibits bvone resorption markers.

NCT ID: NCT03926377 Recruiting - Osteoporosis Clinical Trials

Influence of Dermocorticoids on Bone Mineral Density in Patients With Bullous Pemphigoid

DERMOS
Start date: April 1, 2019
Phase: Phase 4
Study type: Interventional

Bullous pemphigoid is the most common type of bullous skin disease and is clinically characterized by clear-tense bullae, which result in post-bullous cutaneous erosions, altering the skin barrier. The treatment of this pathology consists of the application of high doses of topical corticosteroids (clobetasol propionate) for a prolonged period of at least 6 months. The main objective of this study is to demonstrate a change in bone mineral density at 6 months after initiation of treatment, in subjects with bullous pemphigoid and treated with topical corticosteroid.

NCT ID: NCT03925532 Completed - Osteoporosis Clinical Trials

Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant

Start date: December 19, 2019
Phase: Phase 2
Study type: Interventional

This Phase II trial studies the side effects of denosumab and to see how well it works in treating patients with bone loss who have received a donor stem cell transplant. Patients receiving a donor stem cell transplant may experience accelerated bone loss and an increase risk of bone fractures, leading to a decrease in satisfaction and quality of life. A type of immunotherapy drug called denosumab binds to a protein called RANKL, which may help keep bone from breaking down.

NCT ID: NCT03925051 Completed - Clinical trials for Postmenopausal Osteoporosis

Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers

Start date: July 1, 2019
Phase: Phase 1
Study type: Interventional

CMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once six months and is approved for various indications, including the treatment of postmenopausal women with osteoporosis at increased/high risk of fracture. This phase 1 clincical study investigates the pharmacokinetics, safety and immnogenicity of CMAB807,compared to prolia®, in healthy Chinese male subjects.