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Clinical Trials/NCT06621069
NCT06621069
Completed
Not Applicable

The Effect of Long-term Use of Bisphosphonates on Femur Morphology

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country140 target enrollmentJune 1, 2024

Overview

Phase
Not Applicable
Intervention
Bisphosphonates
Conditions
Osteoporosis
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
140
Locations
1
Primary Endpoint
femoral lateral bowing
Status
Completed
Last Updated
last year

Overview

Brief Summary

Recent studies have shown that bone modeling can occur throughout life, suggesting bone has a persistent ability of adapting structure to loading. Some bone medications have a significant effect on the process of bone modeling based on histological studies. Bisphosphonates (BP), a classical anti-resorption drug which impacts the process of bone turnover, is related with atypical femur fractures while the mechanism is unclear. Several hypotheses are considered competitive. Among them, increased femur bowing is associated with atypical femoral fractures. However, it remains doubtful whether long-term BP use increases femur bowing. Thus, the investigators design this retrospective cohort study.

Detailed Description

If the participants meet the Inclusion Criteria, the investigators will collect the baseline characteristics of patients including age, gender, body mass index (BMI), as well as characteristics of BMD by dual-energy X-ray absorptiometry (DXA), BP treatment (type of drugs, duration before baseline). The primary outcome was femoral lateral bowing (FLB), femoral neck shaft angle (FNSA), and hip knee shaft angle (HKSA) from the frontal plane in standing radiographs of the lower limbs.

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
August 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • standing radiographs of the lower limb

Exclusion Criteria

  • non-standard lower limbs X-ray , rheumatoid arthritis, tumor of the femur, congenital anomalies of the lower extremity

Arms & Interventions

patients with over 5-year BP history

patients who took bisphosphonates over 5 years

Intervention: Bisphosphonates

control patients without BP usage

patients who do not receive bisphosphonates therapy

Intervention: Control

Outcomes

Primary Outcomes

femoral lateral bowing

Time Frame: through study completion, an average of 8 years

Angle between axes of 20% proximal and distal sections of femur diaphysis

Secondary Outcomes

  • femoral neck shaft angle (FNSA)(through study completion, an average of 8 year)
  • hip knee shaft angle(through study completion, an average of 8 years)

Study Sites (1)

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