DiphosphonatesNCT05623540
Bisphosphonates Use After Total Joint Arthroplasty
An observational study of Diphosphonates, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
Background Bisphosphonates has been associated with a decreased risk of revision total joint replacements because of its effects on decreased periprosthetic bone loss and prosthetic migration. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diphosphonates
- What is being tested?
- Bisphosphonates, Combinations
- How many people
- 27,405 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2000to 2 Nov 2022
- How long will I take part?
- 15 Years
- 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 40 years and older
- All sexes
- Adult, Older adult
Study population: International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) was used to identify diagnoses and related procedures. The target cohort in NHIRD were those who underwent primary total joint arthroplasty during the study period (January 1, 2000 to December 31, 2015).
Who may be able to join
- Patients who underwent primary total joint arthroplasty during the study period (January 1, 2000 to December 31, 2015).
Who cannot join
- Patients with total joint arthroplasty before the index date,
- Patients with existing pathologic fracture, nonunion of fracture and partial joint replacement,
- Patients who were lost to follow-up
- Patients < 40 years old
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Tri-Service General Hospital, National Defense Medical Center
Taipei, 11472
About this study
Official title: Postoperative Use of Bisphosphonates Reduces Adverse Outcome After Primary Total Joint Arthroplasty: A Nationwide Population-based Cohort Study
Background Bisphosphonates has been associated with a decreased risk of revision total joint replacements because of its effects on decreased periprosthetic bone loss and prosthetic migration. However, the results in the early literature are inconsistent and the influence of bisphosphonates on associated complications and subsequent total joint arthroplasty (TJA) remains unknown. This study is to investigate the association between the use of bisphosphonates and risk of adverse outcomes after primary TJA.
Materials and Methods This matched cohort study utilized National Health Insurance Research Database in Taiwan to identify patients who underwent primary TJA over a 15-year period (January 2000- December 2015 inclusive). Study participants were further categorized into two groups: bisphosphonates users and nonusers, using propensity score matching. The Kaplan-Meier curve analysis and adjusted hazard ratios (aHR) of revision surgery, adverse outcomes of primary surgery and undergoing subsequent TJA were calculated using Cox regression analysis.
- Conditions
- Diphosphonates
- Being tested
- Bisphosphonates, Combinations
- Keywords
- Bisphosphonates, Total joint arthroplasty, Revision surgery, Periprosthetic fracture
- Medical subject headings
- Periprosthetic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisphosphonates, CombinationsDrug
| Study group | Role | What they receive |
|---|---|---|
| bisphosphonates users | Patients who underwent primary total joint arthroplasty with bisphosphonates use Receives: Drug: Bisphosphonates, Combinations | |
| bisphosphonates nonusers | Patients who underwent primary total joint arthroplasty without bisphosphonates use Receives: Drug: Bisphosphonates, Combinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
revision rate of joint arthroplasty
revision rate of joint arthroplasty after primary surgery
Measured: a 15-year period (January 2000- December 2015 inclusive)
Secondary outcomes (4)
The rate of secondary total joint arthroplasty
The rate of secondary total joint arthroplasty
Measured: a 15-year period (January 2000- December 2015 inclusive)
The rate of periprosthetic joint infection
The rate of periprosthetic joint infection
Measured: a 15-year period (January 2000- December 2015 inclusive)
The rate of periprosthetic fracture
The rate of periprosthetic fracture
Measured: a 15-year period (January 2000- December 2015 inclusive)
Mortality rate
Mortality rate
Measured: a 15-year period (January 2000- December 2015 inclusive)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start1 Jan 2000
- Primary completion31 Dec 2015
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiphosphonatesStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 27,405 participants (actual)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jen-Ta Shih, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623540
- Sponsor's protocol ID
- TSGH-D-110103
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plans to make individual participant data (IPD) available to other researchers.
Publications
Shih JT, Tan TL, Shen PH, Yeh TT, Wu CC, Pan RY, Chien WC, Chung CH, Wang SH. Postoperative Bisphosphonates Use is Associated with Reduced Adverse Outcomes After Primary Total Joint Arthroplasty of Hip and Knee: A Nationwide Population-Based Cohort Study. Calcif Tissue Int. 2024 May;114(5):451-460. doi: 10.1007/s00223-024-01192-6. Epub 2024 Mar 16.
PubMed 38492035
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Use of Bisphosphonates Reduces Adverse Outcome After Primary Total Joint Arthroplasty: A Nationwide Population-based Cohort Study
- ClinicalTrials.gov ID
- NCT05623540
- Acronym / sponsor ID
- TSGH-D-110103
- Conditions
- Diphosphonates
- Keywords
- Bisphosphonates, Total joint arthroplasty, Revision surgery, Periprosthetic fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,405 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 21 Nov 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.
Background Bisphosphonates has been associated with a decreased risk of revision total joint replacements because of its effects on decreased periprosthetic bone loss and prosthetic migration. However, the results in the early literature are inconsistent and the influence of bisphosphonates on associated complications and subsequent total joint arthroplasty (TJA) remains unknown. This study is to investigate the association between the use of bisphosphonates and risk of adverse outcomes after primary TJA.
Materials and Methods This matched cohort study utilized National Health Insurance Research Database in Taiwan to identify patients who underwent primary TJA over a 15-year period (January 2000- December 2015 inclusive). Study participants were further categorized into two groups: bisphosphonates users and nonusers, using propensity score matching. The Kaplan-Meier curve analysis and adjusted hazard ratios (aHR) of revision surgery, adverse outcomes of primary surgery and undergoing subsequent TJA were calculated using Cox regression analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 15 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bisphosphonates users | – | Drug: Bisphosphonates, CombinationsPatients who underwent primary total joint arthroplasty with bisphosphonates use |
| bisphosphonates nonusers | – | Drug: Bisphosphonates, CombinationsPatients who underwent primary total joint arthroplasty without bisphosphonates use |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) was used to identify diagnoses and related procedures. The target cohort in NHIRD were those who underwent primary total joint arthroplasty during the study period (January 1, 2000 to December 31, 2015).
Key inclusion criteria (1 listed)
- Patients who underwent primary total joint arthroplasty during the study period (January 1, 2000 to December 31, 2015).
Key exclusion criteria (4 listed)
- Patients with total joint arthroplasty before the index date,
- Patients with existing pathologic fracture, nonunion of fracture and partial joint replacement,
- Patients who were lost to follow-up
- Patients < 40 years old
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 |
|---|---|---|
| Bisphosphonates, Combinations | Drug | bisphosphonates nonusers, bisphosphonates users |
Primary outcome
revision rate of joint arthroplasty
Time frame: a 15-year period (January 2000- December 2015 inclusive)
revision rate of joint arthroplasty after primary surgery
4 secondary outcomes
The rate of secondary total joint arthroplasty
Time frame: a 15-year period (January 2000- December 2015 inclusive)
The rate of periprosthetic joint infection
Time frame: a 15-year period (January 2000- December 2015 inclusive)
The rate of periprosthetic fracture
Time frame: a 15-year period (January 2000- December 2015 inclusive)
Mortality rate
Time frame: a 15-year period (January 2000- December 2015 inclusive)
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 22 Nov 2022.
- Derived from this study: PubMed 38492035Shih JT, Tan TL, Shen PH, Yeh TT, Wu CC, Pan RY, Chien WC, Chung CH, Wang SH. Postoperative Bisphosphonates Use is Associated with Reduced Adverse Outcomes After Primary Total Joint Arthroplasty of Hip and Knee: A Nationwide Population-Based Cohort Study. Calcif Tissue Int. 2024 May;114(5):451-460. doi: 10.1007/s00223-024-01192-6. Epub 2024 Mar 16.
- Individual participant dataSharing planned: No. There is no plans to make individual participant data (IPD) available to other researchers.
Related trials for Diphosphonates
Active, not recruitingPhase 3
Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta
Osteogenesis Imperfecta
RecruitingPhase 4
Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism
Primary Hyperparathyroidism
Not yet recruitingPhase 1
Pharmacokinetics of Zoledronic Acid in Patients on Dialysis
Chronic Kidney Disease, Osteoporosis
Recruiting
Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy
Cardiac Amyloidosis
Active, not recruiting
Topical Oxygen Therapy for BRONJ
Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ), Oxygen
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 Diphosphonates, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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 22 Nov 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 Taiwan. 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?
revision rate of joint arthroplasty (time frame: a 15-year period (January 2000- December 2015 inclusive)). 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 NCT05623540, which also lists 1 linked publication.
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 Nov 2022.