Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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-). ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

NCT number NCT02223572
Study type Interventional
Source Meir Medical Center
Contact Pnina Rotman, MD
Phone +972-9-7472671
Status Not yet recruiting
Phase N/A
Start date September 2014
Completion date May 2016

See also
  Status Clinical Trial Phase
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 NCT02922478 - Role of Comorbidities in Chronic Heart Failure Study
Recruiting NCT02617303 - Prevention of Falls and Its Consequences in Elderly People N/A
Recruiting NCT02616627 - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients N/A
Recruiting NCT02566655 - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis Phase 1
Recruiting NCT02635022 - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study 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
Completed NCT02003716 - DeFRA Questionnaire as an Anamnestic Form N/A
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
Unknown status NCT01913834 - Nasally and sc Administered Teriparatide in Healthy Volunteers Phase 1
Active, not recruiting NCT01401556 - C-STOP Fracture Trial Phase 3
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A
Completed NCT01694784 - Understanding and Discouraging Overuse of Potentially Harmful Screening Tests N/A
Completed NCT02143674 - Muscle Strengthening Exercises and Global Stretching in Elderly N/A
Recruiting NCT01549028 - Osteoporosis in Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT01387672 - Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study Phase 3
Completed NCT01439139 - Bone UltraSonic Scanner (BUSS): Validation Study N/A
Completed NCT01504230 - Multi-joint Coordination Underlies Upright Balance Control in Elderly With Osteoporosis N/A
Recruiting NCT01956461 - Effects of Teriparatide Therapy for Japanese N/A