OsteoporosisNCT05366621
Post-fracture Medication and Mortality
An observational study of Osteoporosis and Osteoporosis Fracture, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Osteoporotic fracture is a common public-health problem in the whole world. Although postfracture usage of anti-osteoporosis medications, may reduce mortality, recent results have been inconsistent. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteoporosis Fracture, Drug Therapy
- What is being tested?
- Anti-osteoporosis medications
- How many people
- 216,155 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2020to 31 Oct 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The final study participants included those who satisfied the inclusion criteria for both osteoporosis and hip fracture cohorts, and they were followed until 2018.
Who may be able to join
- Newly diagnosed osteoporosis and hip fracture are defined as a claim record from the NHIRD between 2009 and 2017.
Who cannot join
- Patients with a diagnosis of osteoporosis or osteoporotic fractures in 2008 or before were excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Family Medicine, National Cheng Kung Univ Hosp
Tainan
About this study
Official title: The Association Between Anti-osteoporosis Medications and Lowered All Cause Mortality After Osteoporotic Fractures
Osteoporotic fracture is a common public-health problem in the whole world. Although postfracture usage of anti-osteoporosis medications, may reduce mortality, recent results have been inconsistent. The investigators aim to examine associations between osteoporosis medication and mortality in older adults and any type of fracture patients. The investigators also aim to discuss the pleiotropic effects of different types of anti-osteoporosis medications.
Read the detailed description
Osteoporotic fracture has become a serious health and economic burden as life expectancy increases. In a WHO report, the burden of osteoporotic fractures in 2002 was 2.8 million disability-adjusted life years, which is more than that for hypertension and slightly less than that for diabetes mellitus or chronic obstructive pulmonary diseases. Many patients who have had a diagnosed fracture have never been diagnosed with osteoporosis, therefore, closing the gap in osteoporosis treatment is important. This situation is primarily due to the fact that osteoporosis symptoms are often not recognized until a fracture occurs. Osteoporotic fractures, especially those of the hip and vertebral, are associated with an increased risk of death. Early detection of high risk for osteoporotic fractures is important; however, post-fracture management, especially interventions intended to lower mortality, is an emerging public health issue in rapidly aging societies. The burden of osteoporotic fracture is higher than that of hypertension, however, osteoporosis is always given less attention than other chronic diseases by health professionals and the general population.
- Being tested
- Anti-osteoporosis medications
- Medical subject headings
- Osteoporosis, Osteoporotic Fractures, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-osteoporosis medicationsDrug
Also called Bisphosphonates, Denosumab, Hormone-related therapy, Bone-building medication
Medication exposure was defined as the usage of osteoporosis medications approved by the Taiwan Food and Drug Administration (TFDA), including alendronate, risedronate, ibandronate, zoledronic acid, denosumab, raloxifene, bazedoxifene, calcitonin, and teriparatide, but excluded patients using the osteoporosis medication for cancer-related treatments (such as high dosing frequency of zoledronic acid or denosumab).
| Study group | Role | What they receive |
|---|---|---|
| Used osteoporosis medication | Patients who had used osteoporosis medication after osteoporotic fractures. Receives: Drug: Anti-osteoporosis medications | |
| Did not use osteoporosis medication | Patients who didn't use osteoporosis medication after osteoporotic fractures. Receives: Drug: Anti-osteoporosis medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of deaths with and without anti-osteoporotic therapy after hip fracture surgery
This is the number of participants who died during the time of observation from Taiwan's National Health Insurance Research Database.
Measured: 12 years
Number of deaths with or without anti-osteoporosis therapy after hip or vertebral fracture surgery among older adults
This is the number of participants who died during the time of observation from Taiwan's National Health Insurance Research Database.
Measured: 12 years
Number of deaths with and without bisphosphonates after hip or spine fracture surgery
This is the number of participants who died during the time of observation from Taiwan's National Health Insurance Research Database.
Measured: 12 years
Number of deaths with different types of anti-osteoporosis treatments after post-fracture
This is the number of participants who died during the time of observation from Taiwan's National Health Insurance Research Database.
Measured: 12 years
Number of deaths in five leading causes of death with and without anti-osteoporosis treatment after post-fracture
This is the number of participants who died during the time of observation from Taiwan's National Death Registry. The five leading causes are defined as the main five leading causes.
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Nov 2020
- Primary completion30 Sep 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Retrospective
- Enrolment
- 216,155 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Hsing Wu, National Cheng-Kung University Hospital
- Investigators
- Chih-Hsing Wu, MD, Study director, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366621
- Sponsor's protocol ID
- Osteoporosis and Mortality
- Status last verified
- Mar 2023
- First submitted
- 2 May 2022
- Last updated
- 4 Apr 2023
- 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 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Anti-osteoporosis Medications and Lowered All Cause Mortality After Osteoporotic Fractures
- ClinicalTrials.gov ID
- NCT05366621
- Acronym / sponsor ID
- Osteoporosis and Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216,155 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 9 May 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.
Osteoporotic fracture is a common public-health problem in the whole world. Although postfracture usage of anti-osteoporosis medications, may reduce mortality, recent results have been inconsistent. The investigators aim to examine associations between osteoporosis medication and mortality in older adults and any type of fracture patients. The investigators also aim to discuss the pleiotropic effects of different types of anti-osteoporosis medications.
Detailed description
Osteoporotic fracture has become a serious health and economic burden as life expectancy increases. In a WHO report, the burden of osteoporotic fractures in 2002 was 2.8 million disability-adjusted life years, which is more than that for hypertension and slightly less than that for diabetes mellitus or chronic obstructive pulmonary diseases. Many patients who have had a diagnosed fracture have never been diagnosed with osteoporosis, therefore, closing the gap in osteoporosis treatment is important. This situation is primarily due to the fact that osteoporosis symptoms are often not recognized until a fracture occurs. Osteoporotic fractures, especially those of the hip and vertebral, are associated with an increased risk of death. Early detection of high risk for osteoporotic fractures is important; however, post-fracture management, especially interventions intended to lower mortality, is an emerging public health issue in rapidly aging societies. The burden of osteoporotic fracture is higher than that of hypertension, however, osteoporosis is always given less attention than other chronic diseases by health professionals and the general population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Used osteoporosis medication | – | Drug: Anti-osteoporosis medicationsPatients who had used osteoporosis medication after osteoporotic fractures. |
| Did not use osteoporosis medication | – | Drug: Anti-osteoporosis medicationsPatients who didn't use osteoporosis medication after osteoporotic fractures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The final study participants included those who satisfied the inclusion criteria for both osteoporosis and hip fracture cohorts, and they were followed until 2018.
Key inclusion criteria (1 listed)
- Newly diagnosed osteoporosis and hip fracture are defined as a claim record from the NHIRD between 2009 and 2017.
Key exclusion criteria (1 listed)
- Patients with a diagnosis of osteoporosis or osteoporotic fractures in 2008 or before were excluded.
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 |
|---|---|---|
| Anti-osteoporosis medicationsAlso: Bisphosphonates, Denosumab, Hormone-related therapy, Bone-building medicationMedication exposure was defined as the usage of osteoporosis medications approved by the Taiwan Food and Drug Administration (TFDA), including alendronate, risedronate, ibandronate, zoledronic acid, denosumab, raloxifene, bazedoxifene, calcitonin, and teriparatide, but excluded patients using the osteoporosis medication for cancer-related treatments (such as high dosing frequency of zoledronic acid or denosumab). | Drug | Did not use osteoporosis medication, Used osteoporosis medication |
Primary outcome
Number of deaths with and without anti-osteoporotic therapy after hip fracture surgery
Time frame: 12 years
This is the number of participants who died during the time of observation from Taiwan's National Health Insurance Research Database.
Number of deaths with or without anti-osteoporosis therapy after hip or vertebral fracture surgery among older adults
Time frame: 12 years
This is the number of participants who died during the time of observation from Taiwan's National Health Insurance Research Database.
Number of deaths with and without bisphosphonates after hip or spine fracture surgery
Time frame: 12 years
This is the number of participants who died during the time of observation from Taiwan's National Health Insurance Research Database.
Number of deaths with different types of anti-osteoporosis treatments after post-fracture
Time frame: 12 years
This is the number of participants who died during the time of observation from Taiwan's National Health Insurance Research Database.
Number of deaths in five leading causes of death with and without anti-osteoporosis treatment after post-fracture
Time frame: 12 years
This is the number of participants who died during the time of observation from Taiwan's National Death Registry. The five leading causes are defined as the main five leading causes.
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 Apr 2023.
- 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.
Chih-Hsing Wu, MD study director
National Cheng Kung University
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 Osteoporosis and Osteoporosis Fracture, run by National Cheng-Kung University Hospital 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 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: finished, as of the sponsor's last update on 4 Apr 2023. 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?
Number of deaths with and without anti-osteoporotic therapy after hip fracture surgery (time frame: 12 years). The study lists 5 primary outcomes in all. 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 Apr 2023.