Osteoporosis Clinical Trial
— RUBIOfficial title:
Innovative Approach to Geriatric Osteoporosis
The purpose of this study is to find out if one year of romosozumab (Evenity®), a monthly injection given in the arm under the skin, prior to an infusion of zoledronic acid Reclast®, works to treat bone loss and prevent it from worsening in older women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 2027 |
Est. primary completion date | September 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: Elderly women 65 years and older will be considered if: - They reside in an institution (nursing home or assisted living facility or senior care community); - They have a) osteoporosis by axial bone density (spine, hip or forearm BMD T-score= -2.5 SD), b) a previous adult fragility fracture of the spine or hip or c) would be treated based on FRAX and the National Osteoporosis Foundation (NOF) treatment thresholds of a 10 year risk of 10% for a major osteoporotic fracture or = 3% for hip fracture using femoral neck BMD. - Willing and able to complete the informed consent process or provide consent by proxy. Exclusion Criteria: - Those with subacute illnesses who are not expected to survive or who will be discharged in less than 2 years. - Those who have previously had an acute cardiovascular or cerebrovascular event within the preceding year. specifically, no recent history of coronary heart disease, heart failure, significant arrhythmia, stroke or Transient Ischemic Attack (TIA). - Recent cardiovascular disease (CVD) symptoms (significant chest pain, congestive heart failure, shortness of breath, or palpitations or cerebrovascular symptoms such as numbness or weakness in the face, arm, legs, difficulty talking, changes in vision, loss of balance, headache, feeling light-headed or dizzy). - Unstable angina. - Those who are currently on therapy (including a bisphosphonate, denosumab, teriparatide, abaloparatide or romosozumab) or have been on a bisphosphonate for greater than 1 year during the previous 2 years. - Those who are unable to take an intravenous bisphosphonate (zoledronic acid) due to renal insufficiency with eGFR < 35 ml/min. - Vitamin D levels <25 ng/mL. - Participants will be allowed to continue on medications known to affect bone and mineral metabolism (e.g., glucocorticoids, anticonvulsants) because their use is common in this population. - Those who have been treated in the past or present with osteoporosis agents, such as estrogen/progesterone or raloxifene will be allowed to participate and continue on these therapies if prescribed by their physician. - Patients will be allowed to wear hip pads if prescribed by their physician. - Non-ambulatory residents (those who cannot stand and pivot with assistance in order to transfer to the DXA table) will be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Senior Communities | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Susan L. Greenspan | National Institute on Aging (NIA), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone Mineral Density of the total hip | Bone Mineral Density (BMD) of the total hip at 24 months as assessed by dual-energy x-ray absorptiometry (DXA) | 24 months | |
Primary | Bone Mineral Density of the spine | Bone Mineral Density (BMD) of the spine at 24 months as assessed by dual-energy x-ray absorptiometry (DXA) | 24 months |
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 | |
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 | |
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 |
NCT01401556 -
C-STOP Fracture Trial
|
N/A |