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

NCT ID: NCT06621069

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-08-01

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.

Conditions

Osteoporosis; Knee Osteoarthristis

Study Design

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

Study Groups

patients with over 5-year BP history

patients who took bisphosphonates over 5 years

Bisphosphonates

Intervention Type: DRUG

Alendronate Sodium or Zoledronic acid

control patients without BP usage

patients who do not receive bisphosphonates therapy

Control

Intervention Type: OTHER

control without BP

Interventions

Bisphosphonates

Alendronate Sodium or Zoledronic acid

Intervention Type: DRUG

Control

control without BP

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

1. Department of Orthopedics Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2024-0641

Identifier Type: -

Identifier Source: org_study_id