Bone ResorptionPhase 4NCT02760979
The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty
A Phase 4 study testing Denosumab in people with Bone Resorption, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within a year after surgery. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Denosumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 2015
- Phase
- Phase 4
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Knee Osteoarthritis treated with Total Knee Arthroplasty
Who cannot join
- Patients allergies to Denosumab
- Patients with previous Osteoporosis treatment
- Patients with renal failure
- Patients with previous Bisphosphonate treatment for more than 5 years
About this study
Official title: The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty: A Randomised, Double Blind, Placebo Controlled Clinical Trial
This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within a year after surgery.
Read the detailed description
Periprosthetic bone resorption after Total Knee Arthroplasty occurs as a consequence of prosthetic implant on the bone. Some of this patients (up to 13%) develop an aseptic failure of the prosthesis needing revision surgery.
2 groups of patients are treated with Placebo and Denosumab in a double blind prospective trial. Densitometry, Knee society score (KSS), Western Ontario McMaster University Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) were done in both groups at 0,3,6 and 12 months after surgery.
- Conditions
- Bone Resorption
- Being tested
- Denosumab, Placebo
- Keywords
- knee arthroplasty
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Also called Prolia
Denosumab treatment one year after surgery
PlaceboDrug
Also called Serum
Serum one year after surgery
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Active comparator | Patients treated with Denosumab Receives: Drug: Denosumab |
| Placebo | Placebo comparator | Patients treated with placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Mass index
Bone Mass index in gr/cm3
Measured: Change in densitometry before surgery (0) and at three (3) months after surgery
Change in Bone Mass index
Bone Mass index in gr/cm3
Measured: Change in densitometry before surgery (0) and at six (6) months after surgery
Change in Bone Mass index
Bone Mass index in gr/cm3
Measured: Change in densitometry before surgery (0) and at twelve (12) months after surgery
Secondary outcomes (5)
Quality of Life (WOMAC)
Measured: WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery
Quality of life (SF-36)
Measured: SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery
Kidney function
Creatinine clearance
Measured: Before surgery and at three, six and twelve months after surgery
Liver function
ALT, AST
Measured: Before surgery and at three, six and twelve months after surgery
Bone turnover markers
Beta cross lap and Procollagen type 1 n-terminal propeptide (P1NP)
Measured: At three, six and twelve months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bone ResorptionStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Carlos Gonzalez, Principal investigator, Orthopaedic Department-Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760979
- Sponsor's protocol ID
- IIBSP-DEN-2012-24
- Other IDs
- 2012-001285-15
- Status last verified
- Aug 2017
- First submitted
- 28 Apr 2016
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ishii Y, Yagisawa K, Ikezawa Y. Changes in bone mineral density of the proximal femur after total knee arthroplasty. J Arthroplasty. 2000 Jun;15(4):519-22. doi: 10.1054/arth.2000.4639.
PubMed 10884214Sugita T, Umehara J, Sato K, Inoue H. Influence of tibial bone quality on loosening of the tibial component in total knee arthroplasty for rheumatoid arthritis: long-term results. Orthopedics. 1999 Feb;22(2):213-5. doi: 10.3928/0147-7447-19990201-10.
PubMed 10037335Wang CJ, Wang JW, Weng LH, Hsu CC, Huang CC, Chen HS. The effect of alendronate on bone mineral density in the distal part of the femur and proximal part of the tibia after total knee arthroplasty. J Bone Joint Surg Am. 2003 Nov;85(11):2121-6. doi: 10.2106/00004623-200311000-00009.
PubMed 14630840
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty: A Randomised, Double Blind, Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02760979
- Acronym / sponsor ID
- IIBSP-DEN-2012-24
- Conditions
- Bone Resorption
- Keywords
- knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 May 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.
This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within a year after surgery.
Detailed description
Periprosthetic bone resorption after Total Knee Arthroplasty occurs as a consequence of prosthetic implant on the bone. Some of this patients (up to 13%) develop an aseptic failure of the prosthesis needing revision surgery.
2 groups of patients are treated with Placebo and Denosumab in a double blind prospective trial. Densitometry, Knee society score (KSS), Western Ontario McMaster University Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) were done in both groups at 0,3,6 and 12 months after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Active comparator | Drug: DenosumabPatients treated with Denosumab |
| Placebo | Placebo comparator | Drug: PlaceboPatients treated with placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Knee Osteoarthritis treated with Total Knee Arthroplasty
Key exclusion criteria (4 listed)
- Patients allergies to Denosumab
- Patients with previous Osteoporosis treatment
- Patients with renal failure
- Patients with previous Bisphosphonate treatment for more than 5 years
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 |
|---|---|---|
| DenosumabAlso: ProliaDenosumab treatment one year after surgery | Drug | Denosumab |
| PlaceboAlso: SerumSerum one year after surgery | Drug | Placebo |
Primary outcome
Change in Bone Mass index
Time frame: Change in densitometry before surgery (0) and at three (3) months after surgery
Bone Mass index in gr/cm3
Change in Bone Mass index
Time frame: Change in densitometry before surgery (0) and at six (6) months after surgery
Bone Mass index in gr/cm3
Change in Bone Mass index
Time frame: Change in densitometry before surgery (0) and at twelve (12) months after surgery
Bone Mass index in gr/cm3
5 secondary outcomes
Quality of Life (WOMAC)
Time frame: WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery
Quality of life (SF-36)
Time frame: SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery
Kidney function
Time frame: Before surgery and at three, six and twelve months after surgery
Liver function
Time frame: Before surgery and at three, six and twelve months after surgery
Bone turnover markers
Time frame: At three, six and twelve months after surgery
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 11 Aug 2017.
- Background: PubMed 10884214Ishii Y, Yagisawa K, Ikezawa Y. Changes in bone mineral density of the proximal femur after total knee arthroplasty. J Arthroplasty. 2000 Jun;15(4):519-22. doi: 10.1054/arth.2000.4639.
- Background: PubMed 10037335Sugita T, Umehara J, Sato K, Inoue H. Influence of tibial bone quality on loosening of the tibial component in total knee arthroplasty for rheumatoid arthritis: long-term results. Orthopedics. 1999 Feb;22(2):213-5. doi: 10.3928/0147-7447-19990201-10.
- Background: PubMed 14630840Wang CJ, Wang JW, Weng LH, Hsu CC, Huang CC, Chen HS. The effect of alendronate on bone mineral density in the distal part of the femur and proximal part of the tibia after total knee arthroplasty. J Bone Joint Surg Am. 2003 Nov;85(11):2121-6. doi: 10.2106/00004623-200311000-00009.
- 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.
Jose Carlos Gonzalez principal investigator
Orthopaedic Department-Hospital de la Santa Creu i Sant Pau
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosumab in people with Bone Resorption, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 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 11 Aug 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Bone Mass index (time frame: Change in densitometry before surgery (0) and at three (3) months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02760979, which also lists 3 linked publications.
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 11 Aug 2017.