Post-fracture Medication and Mortality

NCT ID: NCT05366621

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 216155 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-10-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Used osteoporosis medication

Patients who had used osteoporosis medication after osteoporotic fractures.

Anti-osteoporosis medications

Intervention Type: 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).

Did not use osteoporosis medication

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

Anti-osteoporosis medications

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Bisphosphonates; Denosumab; Hormone-related therapy; Bone-building medication

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chih-Hsing Wu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chih-Hsing Wu, MD

Role: STUDY_DIRECTOR

National Cheng Kung University

Locations

Department of Family Medicine, National Cheng Kung Univ Hosp

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

Osteoporosis and Mortality

Identifier Type: -

Identifier Source: org_study_id