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| Name | Class |
|---|---|
| Meir Medical Center | OTHER |
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Due to its prevalence worldwide, osteoporosis is considered a serious public health concern. The worldwide annual incidence of Osteoporotic fractures is approximately 2 million in the US only.
Hip fracture is associated with serious disability and excess mortality. Studies have shown that an initial osteoporotic fracture is a major risk factor for a new fracture. An increased risk of 14.8% for a secondary hip fracture has been demonstrated in people that have already sustained a fracture in the past 4 years (In average). These data indicate the major opportunity afforded by secondary fracture prevention strategies.
By responding to the first fracture, we can reduce the incidence of second and subsequent fractures. However, even after longer medical follow-up according to regular standard of care, medical treatment and rehabilitation, the medical system has been unable to translate the eminent risk into an effective preventive treatment.
Study Objectives:
Study Protocol:
The study protocol will begin after the patients, who have been admitted with a primary hip fracture (of osteoporotic nature), were surgically treated (as customary standard of care).
According to hospitalization standard protocol, the patients will be treated with vitamin D and calcium. For the first month the patient will be given a loading dose of 70,000 units. For the next months the patients will receive 50,000-80,000 units per month.
In addition, the patient will be treated with Calcium Pills (Caltrate TAB 600mg, once a day)
In addition to the clinical customary monitoring tests performed during the hospitalization, Biomarkers and safety assessment will be taken:
Follow up visits after hospitalization due to surgery for primary hip fracture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| osteoporotic hip fracture | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hip Xray | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduce number of incidents of secondary hip fracture. | 1 year and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pnina Rotman, MD | Contact | +972-9-7472671 | Pnina.Rotman@clalit.org.il | |
| Eyal Yaacobi, MD | Contact | +972-3-9385700 | Eyal.Yaacobi@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Eyal Yaacobi, M.D. | Meir Medical Center | Principal Investigator |
| Pnina Rotman, MD | Meir Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Kfar Saba | Israel | 44281 | Israel |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D058866 | Osteoporotic Fractures |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| D007869 |
| Leg Injuries |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |