Osseointegrated ImplantsNCT05736640
Osseointegrated Transdermal Femoral Amputation Prostheses
A study testing Denosumab in people with Osseointegrated Implants and Bone Mineral Density, run by University of Aarhus.
Trial summary
Femur amputated patients often suffer from several problems with conventional socket prosthesis. Some experience changes in gait, discomfort when sitting, altered skin conditions (infection, irritation, rashes, sweat), phantom pain or lack of stabilization between the prosthesis and the residual limb. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osseointegrated Implants, Bone Mineral Density
- What is being tested?
- Denosumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 30 Sep 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-70 years
- Scheduled for OI-implant surgery
- Body mass index <30
- Female patients of childbearing age must produce a negative pregnancy test and use effective contraception
- informed consent
Who cannot join
- Diabetes with complication
- Atherosclerosis
- Smoking
- Drug abuse
- Treatment with NSAID or cytostatic
- Active cancer
Show all 12Show fewer
- Liver or kidney insufficiency
- Dementia
- Hip flexion contracture on the affected side >10 degrees
- Body weight >100 kg
- Hypocalcaemia
- Contraindications to denosumab
About this study
Official title: The Effect of Denosumab on Periprosthetic Bone Mineral Density in Six Transfemoral Amputees Treated With Osseointegrated Implants: The Observations From a Terminated Randomized Controlled Trial
Femur amputated patients often suffer from several problems with conventional socket prosthesis. Some experience changes in gait, discomfort when sitting, altered skin conditions (infection, irritation, rashes, sweat), phantom pain or lack of stabilization between the prosthesis and the residual limb. Many have a low score on "health-related quality of life" questionnaires (HRQL).
Some femur amputated patients may be a candidate to osseointegrated prosthesis. Osseointegrated prosthesis is an implant, where the fixture is inserted into the femur canal and an abutment screw, on which the leg-prostheses is inserted, protrudes the skin. By this procedure the patient have a high score on HRQL and experience fewer problems. They have improved gait, reduced discomfort when sitting, increased prosthetic use, and experience fewer skin and pain problems.
Read more
Femur amputee patients formerly mobilized on socket prosthesis have a reduced bone mineral density in the affected femur and pelvis.
The Phd-theses compromise of three studies. The aim of the first study is to follow patients with oosseointegrated prosthesis before and after surgery with DXA-scans to monitor the BMD. In the second study patients will be randomised to receive medical treatment with an RANKL-inhibitor, approved for treatment of osteoporosis, and monitored with DXA, microdialysis and radiostereometry. Depending on the DXA-results patients in the third study may receive fast track rehabilitation.
The hypothesis is that patients with osseointegrated prosthesis will have an increased BMD after surgery, 2 years follow up. Patients receiving RANKL inhibitor will have increased BMD, stability of the prosthesis, and some receive fast-track rehabilitation due to high BMD.
- Conditions
- Osseointegrated Implants, Bone Mineral Density
- Being tested
- Denosumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Active comparator | Not described Receives: Drug: Denosumab |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in periprosthetic bone mineral density
Measured: 30 months po
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Sep 2013
- Primary completion20 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osseointegrated ImplantsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736640
- Sponsor's protocol ID
- 34964
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Denosumab on Periprosthetic Bone Mineral Density in Six Transfemoral Amputees Treated With Osseointegrated Implants: The Observations From a Terminated Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05736640
- Acronym / sponsor ID
- 34964
- Conditions
- Osseointegrated Implants, Bone Mineral Density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 20 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 21 Feb 2023 (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.
Femur amputated patients often suffer from several problems with conventional socket prosthesis. Some experience changes in gait, discomfort when sitting, altered skin conditions (infection, irritation, rashes, sweat), phantom pain or lack of stabilization between the prosthesis and the residual limb. Many have a low score on "health-related quality of life" questionnaires (HRQL).
Some femur amputated patients may be a candidate to osseointegrated prosthesis. Osseointegrated prosthesis is an implant, where the fixture is inserted into the femur canal and an abutment screw, on which the leg-prostheses is inserted, protrudes the skin. By this procedure the patient have a high score on HRQL and experience fewer problems. They have improved gait, reduced discomfort when sitting, increased prosthetic use, and experience fewer skin and pain problems.
Femur amputee patients formerly mobilized on socket prosthesis have a reduced bone mineral density in the affected femur and pelvis.
The Phd-theses compromise of three studies. The aim of the first study is to follow patients with oosseointegrated prosthesis before and after surgery with DXA-scans to monitor the BMD. In the second study patients will be randomised to receive medical treatment with an RANKL-inhibitor, approved for treatment of osteoporosis, and monitored with DXA, microdialysis and radiostereometry. Depending on the DXA-results patients in the third study may receive fast track rehabilitation.
The hypothesis is that patients with osseointegrated prosthesis will have an increased BMD after surgery, 2 years follow up. Patients receiving RANKL inhibitor will have increased BMD, stability of the prosthesis, and some receive fast-track rehabilitation due to high BMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Active comparator | Drug: Denosumab |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18-70 years
- Scheduled for OI-implant surgery
- Body mass index <30
- Female patients of childbearing age must produce a negative pregnancy test and use effective contraception
- informed consent
Key exclusion criteria (12 listed)
- Diabetes with complication
- Atherosclerosis
- Smoking
- Drug abuse
- Treatment with NSAID or cytostatic
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 |
|---|---|---|
| Denosumab | Drug | Denosumab |
| Placebo | Drug | Placebo |
Primary outcome
change in periprosthetic bone mineral density
Time frame: 30 months po
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 21 Apr 2023.
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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 Denosumab in people with Osseointegrated Implants and Bone Mineral Density, run by University of Aarhus.
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 5 inclusion and 12 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 21 Apr 2023. 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. Some participants in this study may receive a placebo. 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 periprosthetic bone mineral density (time frame: 30 months po). 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 21 Apr 2023.