Femur FractureNCT05183308
Combined Drug Therapy in Lateral Fragility Fractures of the Femur
An observational study of Femur Fracture, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
It was conducted a prospective study with a series of 50 patients treated by intramedullary nail using Clodronic acid and Vitamin D (study group including 25 patients) and patients with the same fractures treated with Vitamin D alone (control group including 25 patients). Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Femur Fracture
- What is being tested?
- Clodronic Acid
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2019to 1 Mar 2020
- Phase
- Observational
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fifty (50) patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between May 2019 and March 2020 with lateral fragility fracture were prospectively recruited.
Who may be able to join
- femur fractures type 31-A1, A2, (Muller ME, Nazarian S, Kock P et al.);
- age 60 - 85 years;
- co-operative patients;
- Body Mass Index (BMI) < 30 Kg/m²;
- patients treated by intramedullary nailing surgery (PFNA Synthes®);
- patients with osteoporosis disease if T-Score< -2,5;
Who cannot join
- patients with heart, kidney, neurological diseases;
- patients with metabolic and systemic disease (rheumatoid arthritis, diabetes mellitus);
- previous surgery or severe osteoarthritis of lower limbs;
- specific drugs treatments such as anticoagulants or psychiatric drugs.
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
Bari, 70124
About this study
Official title: The Effect of Combined Drug Therapy in Lateral Fragility Fractures of the Femur:a Clinical Study
It was conducted a prospective study with a series of 50 patients treated by intramedullary nail using Clodronic acid and Vitamin D (study group including 25 patients) and patients with the same fractures treated with Vitamin D alone (control group including 25 patients).
One independent observer performed clinical, biochemical and functional evaluations at T0 (1st day post-surgery) and at T1 (12 months later) Biochemical markers (serum calcium level, serum phosphate level, PTH (parathormone), Vitamin D, serum C-terminal telopeptide), VAS (Visual Analogic Scale) and HHS (Harris Hip Score) score, and femur densitometric views were administered at each evaluation.
- Conditions
- Femur Fracture
- Being tested
- Clodronic Acid
- Keywords
- fragility lateral femoral fractures, bisphosphonates, clodronic acid, bone density
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clodronic AcidDrug
Osteoporotic fracture treated with surgical and medical therapy
| Study group | Role | What they receive |
|---|---|---|
| patients treated with Vitamin D | Not described | |
| patients treated with Vitamin D and Clodronic Acid | Not described Receives: Drug: Clodronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogic Scale
The Hip Pain was quantified using the Visual Analogic Scale ranging between 0 (no pain) and 10 points (worst imaginable pain).
Measured: Day 1; Month 12 (after surgey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 May 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183308
- Sponsor's protocol ID
- Femur-Clodronic Acid
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Drug Therapy in Lateral Fragility Fractures of the Femur:a Clinical Study
- ClinicalTrials.gov ID
- NCT05183308
- Acronym / sponsor ID
- Femur-Clodronic Acid
- Conditions
- Femur Fracture
- Keywords
- fragility lateral femoral fractures, bisphosphonates, clodronic acid, bone density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 10 Jan 2022 (actual)
- 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.
It was conducted a prospective study with a series of 50 patients treated by intramedullary nail using Clodronic acid and Vitamin D (study group including 25 patients) and patients with the same fractures treated with Vitamin D alone (control group including 25 patients).
One independent observer performed clinical, biochemical and functional evaluations at T0 (1st day post-surgery) and at T1 (12 months later) Biochemical markers (serum calcium level, serum phosphate level, PTH (parathormone), Vitamin D, serum C-terminal telopeptide), VAS (Visual Analogic Scale) and HHS (Harris Hip Score) score, and femur densitometric views were administered at each evaluation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients treated with Vitamin D | – | – |
| patients treated with Vitamin D and Clodronic Acid | – | Drug: Clodronic Acid |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fifty (50) patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between May 2019 and March 2020 with lateral fragility fracture were prospectively recruited.
Key inclusion criteria (6 listed)
- femur fractures type 31-A1, A2, (Muller ME, Nazarian S, Kock P et al.);
- age 60 - 85 years;
- co-operative patients;
- Body Mass Index (BMI) < 30 Kg/m²;
- patients treated by intramedullary nailing surgery (PFNA Synthes®);
Key exclusion criteria (4 listed)
- patients with heart, kidney, neurological diseases;
- patients with metabolic and systemic disease (rheumatoid arthritis, diabetes mellitus);
- previous surgery or severe osteoarthritis of lower limbs;
- specific drugs treatments such as anticoagulants or psychiatric drugs.
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 |
|---|---|---|
| Clodronic AcidOsteoporotic fracture treated with surgical and medical therapy | Drug | patients treated with Vitamin D and Clodronic Acid |
Primary outcome
Change in Visual Analogic Scale
Time frame: Day 1; Month 12 (after surgey)
The Hip Pain was quantified using the Visual Analogic Scale ranging between 0 (no pain) and 10 points (worst imaginable pain).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femur Fracture, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 4 Feb 2022. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Visual Analogic Scale (time frame: Day 1; Month 12 (after surgey)). 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 Feb 2022.