Post-fracture Medication and Mortality

Sponsor
National Cheng-Kung University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05366621
Collaborator
(none)
216,155
1
12
18074.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 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

Study Type:
Observational
Actual Enrollment :
216155 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Association Between Anti-osteoporosis Medications and Lowered All Cause Mortality After Osteoporotic Fractures
Actual Study Start Date :
Nov 1, 2020
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Used osteoporosis medication

Patients who had used osteoporosis medication after osteoporotic fractures.

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).
Other Names:
  • Bisphosphonates
  • Denosumab
  • Hormone-related therapy
  • Bone-building medication
  • Did not use osteoporosis medication

    Patients who didn't use osteoporosis medication after osteoporotic fractures.

    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).
    Other Names:
  • Bisphosphonates
  • Denosumab
  • Hormone-related therapy
  • Bone-building medication
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    5. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Family Medicine, National Cheng Kung Univ Hosp Tainan Taiwan

    Sponsors and Collaborators

    • National Cheng-Kung University Hospital

    Investigators

    • Study Director: Chih-Hsing Wu, MD, National Cheng Kung University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chih-Hsing Wu, Associate Professor, National Cheng-Kung University Hospital
    ClinicalTrials.gov Identifier:
    NCT05366621
    Other Study ID Numbers:
    • Osteoporosis and Mortality
    First Posted:
    May 9, 2022
    Last Update Posted:
    May 13, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 13, 2022