Post-fracture Medication and Mortality

Completed

• Conditions: Drug Therapy; Mortality; Adherence, Medication; Osteoporosis; Osteoporosis Fracture
• Interventions: Drug: Anti-osteoporosis medications

• Registration Number: NCT05366621
• Lead Sponsor: National Cheng-Kung University Hospital

Brief 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.

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 Timeline

• Study Start: 2020-11-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-31
• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216155

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Used osteoporosis medication	Anti-osteoporosis medications	Patients who had used osteoporosis medication after osteoporotic fractures.
Did not use osteoporosis medication	Anti-osteoporosis medications	Patients who didn't use osteoporosis medication after osteoporotic fractures.

Primary Outcome Measures

Name	Time	Method
Number of deaths with and without bisphosphonates after hip or spine fracture surgery	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 anti-osteoporotic therapy after hip fracture surgery	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	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	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	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.

Trial Locations

Locations (1)

Department of Family Medicine, National Cheng Kung Univ Hosp; 🇨🇳 Tainan, Taiwan