Osteoporosis Clinical Trial
Official title:
Prevalence of Osteoporosis and Fractures in Patients With Hepatic Cirrhosis and Investigation of the Associated Factors
Osteoporosis is a common complication in chronic liver disease, especially in the late
stages of the disease. Good nutrition and calcium and vitamin D supplementation are
recommended for the prevention and treatment of osteoporosis. There are no specific
guidelines for its pharmacological treatment, but bisphosphonates have been shown to be
effective in increasing bone mass in patients with chronic cholestasis, with a good safety
profile.
There are few studies evaluating the prevalence of osteoporosis in patients with cirrhosis
(except for primary biliary cholangitis (PBC)). There are no clear recommendations for
osteoporosis screening in cirrhotic patients. A diagnosis and early therapeutic intervention
before the onset of the complications derived would significantly improve the quality of
life and decrease the morbidity and mortality associated with osteoporosis and fractures
Objective:
-To assess the prevalence of osteoporosis and fragility fractures in patients with liver
cirrhosis in our country and the risk factors associated
Method:
Patients diagnosed with hepatic cirrhosis, other than PBC, will be included in any Child
stage during a hospital admission. Epidemiological, demographic, clinical, analytical and
imaging data (dorso-lumbar spine radiography, bone densitometry and Trabecular Bone Score)
will be evaluated. A descriptive statistic of the main variables will be carried out as well
as a multivariate analysis to evaluate the predictive factors of osteoporosis and / or
fragility fractures
Osteoporosis is a common complication in chronic liver disease, especially in the late
stages of the disease. The main mechanism involved in the development of osteoporosis in
patients with cirrhosis is the deficit of bone formation due to the harmful effect of
substances such as bilirubin and bile acids or the toxic effect of alcohol or iron on
osteoblasts .
Good nutrition and calcium and vitamin D supplementation are recommended for the prevention
and treatment of osteoporosis. There are no specific guidelines for its pharmacological
treatment, but bisphosphonates have been shown to be effective in increasing bone mass in
patients with chronic cholestasis, with a good safety profile.
Hospital admissions in relation to osteoporotic fractures in cirrhotic patients are frequent
with a high morbidity and mortality rate. There are few studies evaluating the prevalence of
osteoporosis in patients with cirrhosis with a different etiology from PBC and the existing
series are published years ago with few patient numbers. There are no clear recommendations
for osteoporosis screening in cirrhotic patients. A diagnosis and early therapeutic
intervention before the onset of the complications derived would significantly improve the
quality of life and decrease the morbidity and mortality associated with osteoporosis and
fractures
Objective:
- To assess the prevalence of osteoporosis and fragility fractures in patients with liver
cirrhosis in our country.
- To assess the risk factors associated with osteoporosis and fractures in these
patients.
Method:
Patients diagnosed with hepatic cirrhosis, other than PBC, will be included in any Child
stage during a hospital admission. Epidemiological, demographic, clinical, analytical and
imaging data (dorso-lumbar spine radiography, bone densitometry and Trabecular Bone Score)
will be evaluated. Additional visits to those already carried out in normal practice will
not be necessary. A descriptive statistic of the main variables will be carried out as well
as a multivariate analysis to evaluate the predictive factors of osteoporosis and / or
fragility fractures
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT06287502 -
Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis
|
N/A | |
| Completed |
NCT03822078 -
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women
|
Phase 1 | |
| Recruiting |
NCT05845021 -
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
|
N/A | |
| Completed |
NCT00092066 -
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
|
Phase 3 | |
| Recruiting |
NCT04754711 -
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
|
N/A | |
| Completed |
NCT04736693 -
Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
|
||
| Not yet recruiting |
NCT06431867 -
Primary Care Management of Osteoporosis in Older Women
|
||
| Completed |
NCT02922478 -
Role of Comorbidities in Chronic Heart Failure Study
|
||
| Recruiting |
NCT02616627 -
Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
|
||
| Recruiting |
NCT02635022 -
Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
|
||
| Active, not recruiting |
NCT02617303 -
Prevention of Falls and Its Consequences in Elderly People
|
N/A | |
| Completed |
NCT02566655 -
Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis
|
Phase 1 | |
| Completed |
NCT02559648 -
Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis
|
Phase 2 | |
| Completed |
NCT03420716 -
Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women
|
N/A | |
| Not yet recruiting |
NCT02223572 -
Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture
|
N/A | |
| Not yet recruiting |
NCT01854086 -
Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday
|
N/A | |
| Unknown status |
NCT01913834 -
Nasally and sc Administered Teriparatide in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT02003716 -
DeFRA Questionnaire as an Anamnestic Form
|
N/A | |
| Completed |
NCT01694784 -
Understanding and Discouraging Overuse of Potentially Harmful Screening Tests
|
N/A | |
| Completed |
NCT02143674 -
Muscle Strengthening Exercises and Global Stretching in Elderly
|
N/A |