Osteoporosis Clinical Trial
Official title:
Improving Osteoporosis Care in High-Risk Home Health Patients Through a High-Intensity Intervention
SPECIFIC AIMS: We propose a three-year study to develop a high-intensity intervention to
improve osteoporosis care and test a novel intervention in a group-randomized trial of 27
home health offices and 1,000 patients referred to home health care with a history of
fracture.
Aim 1. Develop an intervention to promote osteoporosis treatment that includes: (1) training
to enhance nurse-patient and nurse-physician risk communication regarding osteoporosis and
fracture risk; (2) automated prompts within the home health agency's electronic medical
record system to promote appropriate osteoporosis management; and (3) implementation of
osteoporosis-related standardized care pathways and order sets.
Aim 2. Conduct a group-randomized trial to test the effectiveness of the intervention to
promote initial use of osteoporosis medications and adherence to treatment after discharge
from home health. We hypothesize that:
H1: Patients in the intervention group will have increased initial receipt of osteoporosis
prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis
compared to patients receiving usual care; H2: Patients in the intervention group will
demonstrate increased persistence in the use of these therapies compared to those receiving
usual care.
Secondary Aims (SA) will include exploratory analyses of fracture related morbidity and
mortality, patient-reported quality of life, and health services utilization and costs.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
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 |
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 | |
Completed |
NCT02559648 -
Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis
|
Phase 2 | |
Completed |
NCT02003716 -
DeFRA Questionnaire as an Anamnestic Form
|
N/A | |
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 |
NCT01757340 -
Calorie Restriction With Leucine Supplementation
|
N/A | |
Completed |
NCT01401556 -
C-STOP Fracture Trial
|
N/A |