Hip FractureNCT02699502
Metabolic Therapy in Patients With Osteoporosis After Hip Fracture by an Orthopedic-rehabilitation-metabolic Team
A study testing matching an appropriate drug therapy to patients with osteoporotic hip fractures in people with Hip Fracture, run by Meir Medical Center.
Trial summary
Metabolic therapy in patients with osteoporosis after hip fracture by cooperation orthopedic-rehabilitation-metabolic: Determination of drug treatment regardless of reaching the follow-up clinic Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hip Fracture
- What is being tested?
- matching an appropriate drug therapy to patients with osteoporotic hip fractures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2017
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients were analyzed could Department of Orthopedics with a hip fracture
Who cannot join
- -
About this study
Official title: Metabolic Therapy in Patients With Osteoporosis After Hip Fracture by Cooperation Orthopedic-rehabilitation-metabolic: Determination of Drug Treatment Regardless of Reaching the Follow-up Clinic
Metabolic therapy in patients with osteoporosis after hip fracture by cooperation orthopedic-rehabilitation-metabolic: Determination of drug treatment regardless of reaching the follow-up clinic
Read the detailed description
Osteoporotic hip fractures are a significant cause of morbidity and mortality in older age. Patients with this fracture are at high risk of further fracture, it can be reduced by appropriate metabolic therapy. However, only 30% of patients after a hip fracture receive basic treatment appropriate calcium and vitamin D, only 10-15% receive complementary metabolic therapy more drugs prevent bone resorption, or bone-building drugs as recommended in the literature, the prevention of further fractures. studies conducted in the past have proven, multi-disciplinary team of dedicated financial institution may increase appropriate treatment and improve the quality of care in these patients.
Previous data in our institution has shown that 84% of patients with hip fractures received calcium and vitamin D during hospitalization, but only 47% of the patients came to the metabolic clinic. Moreover, of the patients who came to the metabolic clinic, only 46% were put on complementary metabolic therapy, mostly due to a lack of sufficient vitamin D level. In the present study investigators attempt to treat patients without physical attendance at the metabolic clinic.
- Conditions
- Hip Fracture
- Being tested
- matching an appropriate drug therapy to patients with osteoporotic hip fractures
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
matching an appropriate drug therapy to patients with osteoporotic hip fracturesOther
The process involves reviewing patients characteristics virtually and finding the right drug for them while they are still in the hospital. After matching an appropriate drug, getting it through regulatory authorities to the family physician
| Study group | Role | What they receive |
|---|---|---|
| patients with osteoporotic hip fractures | Experimental | The intervention includes matching an appropriate drug to patients with hip fractures. All the relevant parameters regarding the patients with osteoporotic hip fractures will be reviewed (age, kidney function, previous treatment) and an appropriate anti osteoporosis medication will be determined. A recommendation regarding treatment will be sent to the local regulatory authorities, which will send the approved recommendation the the family physician. Receives: Other: matching an appropriate drug therapy to patients with osteoporotic hip fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with hip fracture that will receive anti osteoporosis therapy without attending the metabolic clinic in comparison to previous results in the study mentioned above (No. Helsinki 0072-14-MMC)
Measured: half a year
Secondary outcomes (2)
Number of drugs that will be approved by the regulatory authorities
Measured: half a year
Number of drugs that will be prescribed by family physicians
Measured: half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699502
- Sponsor's protocol ID
- 0210-15-MMC
- Status last verified
- Feb 2016
- First submitted
- 8 Feb 2016
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Therapy in Patients With Osteoporosis After Hip Fracture by Cooperation Orthopedic-rehabilitation-metabolic: Determination of Drug Treatment Regardless of Reaching the Follow-up Clinic
- ClinicalTrials.gov ID
- NCT02699502
- Acronym / sponsor ID
- 0210-15-MMC
- Conditions
- Hip Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Mar 2016 (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.
Metabolic therapy in patients with osteoporosis after hip fracture by cooperation orthopedic-rehabilitation-metabolic: Determination of drug treatment regardless of reaching the follow-up clinic
Detailed description
Osteoporotic hip fractures are a significant cause of morbidity and mortality in older age. Patients with this fracture are at high risk of further fracture, it can be reduced by appropriate metabolic therapy. However, only 30% of patients after a hip fracture receive basic treatment appropriate calcium and vitamin D, only 10-15% receive complementary metabolic therapy more drugs prevent bone resorption, or bone-building drugs as recommended in the literature, the prevention of further fractures. studies conducted in the past have proven, multi-disciplinary team of dedicated financial institution may increase appropriate treatment and improve the quality of care in these patients.
Previous data in our institution has shown that 84% of patients with hip fractures received calcium and vitamin D during hospitalization, but only 47% of the patients came to the metabolic clinic. Moreover, of the patients who came to the metabolic clinic, only 46% were put on complementary metabolic therapy, mostly due to a lack of sufficient vitamin D level. In the present study investigators attempt to treat patients without physical attendance at the metabolic clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with osteoporotic hip fractures | Experimental | Other: matching an appropriate drug therapy to patients with osteoporotic hip fracturesThe intervention includes matching an appropriate drug to patients with hip fractures. All the relevant parameters regarding the patients with osteoporotic hip fractures will be reviewed (age, kidney function, previous treatment) and an appropriate anti osteoporosis medication will be determined. A recommendation regarding treatment will be sent to the local regulatory authorities, which will send the approved recommendation the the family physician. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients were analyzed could Department of Orthopedics with a hip fracture
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| matching an appropriate drug therapy to patients with osteoporotic hip fracturesThe process involves reviewing patients characteristics virtually and finding the right drug for them while they are still in the hospital. After matching an appropriate drug, getting it through regulatory authorities to the family physician | Other | patients with osteoporotic hip fractures |
Primary outcome
The number of patients with hip fracture that will receive anti osteoporosis therapy without attending the metabolic clinic in comparison to previous results in the study mentioned above (No. Helsinki 0072-14-MMC)
Time frame: half a year
2 secondary outcomes
Number of drugs that will be approved by the regulatory authorities
Time frame: half a year
Number of drugs that will be prescribed by family physicians
Time frame: half a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing matching an appropriate drug therapy to patients with osteoporotic hip fractures in people with Hip Fracture, run by Meir Medical Center.
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 1 inclusion and 1 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 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with hip fracture that will receive anti osteoporosis therapy without attending the metabolic clinic in comparison to previous results in the study mentioned above (No. Helsinki 0072-14-MMC) (time frame: half a year). 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 4 Mar 2016.