Hip FracturesNCT02223572
Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture
A study testing hip Xray in people with Hip Fractures and Osteoporotic Fractures, run by pninarotman at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Osteoporotic Fractures, Osteoporosis
- What is being tested?
- hip Xray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years old
- Patients diagnosed with low energy osteoporotic hip fracture, and was treated under surgery.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Meir Medical Center
Kfar Saba, Israel, 44281
Eyal Yaacobi, MD, 972-3-9385700, Eyal.Yaacobi@clalit.org.il
Pnina Rotman, MD, 972-9-7472671, Pnina.Rotman@clalit.org.il
About this study
Official title: Secondary Fracture Prevention in Patients Hospitalized for Hip Fracture: Adding the Metabolic Treatment to the Surgical One.
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.
Read the 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:
- 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:
- Vitamin D
- 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).
- Follow up visits after hospitalization due to surgery for primary hip fracture.
- 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).
- 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).
- 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
- Being tested
- hip Xray
- Medical subject headings
- Hip Fractures, Osteoporotic Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip XrayRadiation
| Study group | Role | What they receive |
|---|---|---|
| osteoporotic hip fracture | Experimental | Not described Receives: Radiation: hip Xray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce number of incidents of secondary hip fracture.
Measured: 1 year and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- pninarotman
- Sponsor type
- University, hospital or other
- Collaborators
- Meir Medical Center
- Responsible party
- Sponsor-investigator, pninarotman, Meir Medical Center
- Investigators
- Eyal Yaacobi, M.D., Principal investigator, Meir Medical CenterPnina Rotman, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223572
- Sponsor's protocol ID
- HipFracture2014
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Fracture Prevention in Patients Hospitalized for Hip Fracture: Adding the Metabolic Treatment to the Surgical One.
- ClinicalTrials.gov ID
- NCT02223572
- Acronym / sponsor ID
- HipFracture2014
- Conditions
- Hip Fractures, Osteoporotic Fractures, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- pninarotmanUniversity, hospital or other
- Collaborators
- Meir Medical Center
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Vitamin D
- 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).
- Follow up visits after hospitalization due to surgery for primary hip fracture.
- 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).
- 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).
- 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteoporotic hip fracture | Experimental | Radiation: hip Xray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults over 18 years old
- Patients diagnosed with low energy osteoporotic hip fracture, and was treated under surgery.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hip Xray | Radiation | osteoporotic hip fracture |
Primary outcome
Reduce number of incidents of secondary hip fracture.
Time frame: 1 year and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal Yaacobi, M.D. principal investigator
Meir Medical Center
Pnina Rotman, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hip Xray in people with Hip Fractures and Osteoporotic Fractures, run by pninarotman at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pnina Rotman, MD (+972-9-7472671, Pnina.Rotman@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce number of incidents of secondary hip fracture. (time frame: 1 year and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014.