Post-fracture Medication and Mortality

Osteoporosis Clinical Trial

Official title:

The Association Between Anti-osteoporosis Medications and Lowered All Cause Mortality After Osteoporotic Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05366621
• Other study ID #: Osteoporosis and Mortality
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: March 2023
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216155
• Est. completion date: October 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Newly diagnosed osteoporosis and hip fracture are defined as a claim record from the NHIRD between 2009 and 2017.

Exclusion Criteria:

• Patients with a diagnosis of osteoporosis or osteoporotic fractures in 2008 or before were excluded.

Related Conditions & MeSH terms

• Adherence, Medication
• Drug Therapy
• Fractures, Bone
• Mortality
• Osteoporosis
• Osteoporosis Fracture
• Osteoporotic Fractures

Intervention

Drug:
• Anti-osteoporosis medications
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).

Locations

Country	Name	City	State
Taiwan	Department of Family Medicine, National Cheng Kung Univ Hosp	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 years
Primary	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.	12 years
Primary	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.	12 years
Primary	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.	12 years
Primary	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.	12 years