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NCT Number: NCT05366621

Post-fracture Medication and Mortality

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.

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Key information

Conditions

Osteoporosis Adherence, Medication Behavior Bone Diseases Bone Diseases, Metabolic Drug Therapy Fractures, Bone Health Behavior Medication Adherence Metabolic Diseases Mortality Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Fracture Osteoporotic Fractures Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Family Medicine, National Cheng Kung Univ Hosp

Tainan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-osteoporosis medications

Drug

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).

Other names: Bisphosphonates, Denosumab, Hormone-related therapy, Bone-building medication

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 9, 2022
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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