Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture

NCT ID: NCT02223572

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-05-31

Brief Summary

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.

Detailed Description

Study Objectives:

• To create a treatment, follow up and rehabilitation protocol for patients who suffered from a hip fracture, in order to prevent a secondary fracture.
• To demonstrate that a combined treatment from the Hip Fractures Clinic as well as the regular standard treatment and rehabilitation suggested by the Bone Health Clinic (both in addition to standard medication prescribed for osteoporosis) will result in a significant reduction of second and subsequent fractures.

Study Protocol:

1. 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).

2. 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)

3. In addition to the clinical customary monitoring tests performed during the hospitalization, Biomarkers and safety assessment will be taken:

1. Vitamin D

2. Bone Markers - Bone markers will be taken three days after the patient was admitted, and one more time six months later (as part of follow up visit).

4. Follow up visits after hospitalization due to surgery for primary hip fracture.

1. Follow up visits at the Hip Fracture Clinic will occur in intervals of: six weeks, 3 months, 6 months and a year, since the patient had been released from hospitalization. At follow up visit, the patient will be assessed for physical examination, hip X-ray and the rehabilitation progression Questionnaire (HHS).

2. Follow up visits at the Bone Health Clinic will occur between 6 weeks to 3 months since the patient had been released from hospitalization (as part of regular standard of care).

3. A 3cc Serum sample will be taken with the purpose to serve on future studies and examine new markers such as bone markers SCLEROSTIN. There will be no further use of these samples. The samples will remain in deep freeze temperature (C˚70-).

Conditions

Hip Fractures; Osteoporotic Fractures; Osteoporosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

osteoporotic hip fracture

Group Type: EXPERIMENTAL

hip Xray

Intervention Type: RADIATION

Interventions

hip Xray

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Adults over 18 years old
• Patients diagnosed with low energy osteoporotic hip fracture, and was treated under surgery.

Exclusion Criteria

• Patients not diagnosed with osteoporosis.
• Patients diagnosed with high energy osteoporotic hip fracture.
• Patients that suffered from Multiple Trauma.
• Patients diagnosed with Metabolic diseases or Genetic diseases.
• Pregnant women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: collaborator

pninarotman

OTHER

Sponsor Role: lead

Responsible Party

pninarotman

Depart. of Medicine 'E' Deputy Head

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eyal Yaacobi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Pnina Rotman, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Meir Medical Center

Kfar Saba, Israel, Israel

Countries

Israel

Central Contacts

Pnina Rotman, MD

Role: CONTACT

Pnina.Rotman@clalit.org.il

+972-9-7472671

Eyal Yaacobi, MD

Role: CONTACT

Eyal.Yaacobi@clalit.org.il

+972-3-9385700

Facility Contacts

Eyal Yaacobi, MD

Role: primary

Eyal.Yaacobi@clalit.org.il

972-3-9385700

Pnina Rotman, MD

Role: backup

Pnina.Rotman@clalit.org.il

972-9-7472671

Other Identifiers

HipFracture2014

Identifier Type: -

Identifier Source: org_study_id