Post-fracture Medication and Mortality

NCT05366621 | Completed

• 1 other identifier: Osteoporosis and Mortality
• Study Type: observational
• Target: 216,155
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Osteoporosis Fracture; Drug Therapy; Mortality; Adherence, Medication

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Used osteoporosis medication

Patients who had used osteoporosis medication after osteoporotic fractures.

Drug: Anti-osteoporosis medications

Did not use osteoporosis medication

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

Drug: Anti-osteoporosis medications

Interventions

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).

Also known as: Bisphosphonates, Denosumab, Hormone-related therapy, Bone-building medication

Did not use osteoporosis medication; Used osteoporosis medication

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Department of Family Medicine, National Cheng Kung Univ Hosp

Tainan, Taiwan

Location

MeSH Terms

Conditions

Osteoporosis; Osteoporotic Fractures; Medication Adherence

Interventions

Diphosphonates; Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chih-Hsing Wu, MD

  National Cheng Kung University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 9, 2022
• Study Start: November 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: October 31, 2021
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)