Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00172224
Other study ID # 32244
Secondary ID NSC 91-2314-B-00
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated November 13, 2012
Start date August 2002

Study information

Verified date November 2012
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

The etiology and pathogenesis of osteoporosis has been extensively discussed. The relationship between bone blood circulation and the formation of bony trabeculae has been less understood. There is plenty of indirect evidence highly suggestive of the correlation between these two factors, such as: the number of blood vessels in the per unit area of the bone marrow was decreased in the osteoporotic bone, indicating the possible role of a microvascular defect in the pathogenesis of osteoporosis.

Furthermore, the bone mineral density in severe arteriosclerotic patients was lower than in the less affected subjects. In a large scale epidemiologic study, diminished bone mineral density was strongly associated with increased deaths from stroke. Osteopenia was also associated with an increased risk of stroke. These reports highly suggest the effect of ischemia on bone metabolism and make the investigators more interested in further investigation.

A dynamic contrast-enhanced magnetic resonance (MR) study was used recently in evaluating the blood perfusion of bone tumors. This method also has a strong correlation with the microsphere blood flow measurements. The investigator (T.F. Shih) used the dynamic MR in her recent two researches:

1. To differentiate benign versus malignant spinal compression fractures.

2. To evaluate the blood perfusion of non-fractured, normal-appearing vertebral bodies and find its significant correlation with aging and sex.

The alterations of bone marrow perfusion are synchronous with the changes of bone mineral density. Thus, based on the investigators' previous research work, they propose to further explore the relationship between bone marrow perfusion and bone mineral density in different age groups.


Description:

The etiology and pathogenesis of osteoporosis has been extensively discussed. The relationship between bone blood circulation and the formation of bony trabeculae has been less understood. There is plenty of indirect evidence highly suggestive of the correlation between these two factors, such as: the number of blood vessels in the per unit area of the bone marrow was decreased in the osteoporotic bone, indicating the possible role of a microvascular defect in the pathogenesis of osteoporosis.

Furthermore, the bone mineral density in severe arteriosclerotic patients was lower than in the less affected subjects. In a large scale epidemiologic study, diminished bone mineral density was strongly associated with increased deaths from stroke. Osteopenia was also associated with an increased risk of stroke. These reports highly suggest the effect of ischemia on bone metabolism and make the investigators more interested in further investigation.

A dynamic contrast-enhanced magnetic resonance (MR) study was used recently in evaluating the blood perfusion of bone tumors. This method also has a strong correlation with the microsphere blood flow measurements. The investigator (T.F. Shih) used the dynamic MR in her recent two researches:

1. To differentiate benign versus malignant spinal compression fractures.

2. To evaluate the blood perfusion of non-fractured, normal-appearing vertebral bodies and find its significant correlation with aging and sex.

The alterations of bone marrow perfusion are synchronous with the changes of bone mineral density. Thus, based on the investigators' previous research work, they propose to further explore the relationship between bone marrow perfusion and bone mineral density in different age groups.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- Normal subjects

- Elder subjects with osteoporosis

Exclusion Criteria:

- History of malignancy or infection

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Tiffany Ting-Fang Shih Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

See also
  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 NCT02635022 - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Recruiting NCT02616627 - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
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
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Completed NCT03420716 - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women N/A
Completed NCT02559648 - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis Phase 2
Unknown status NCT01913834 - Nasally and sc Administered Teriparatide in Healthy Volunteers Phase 1
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
Completed NCT02003716 - DeFRA Questionnaire as an Anamnestic Form N/A
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A
Completed NCT01694784 - Understanding and Discouraging Overuse of Potentially Harmful Screening Tests N/A