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

Completed

• Conditions: Osteoporosis; Knee Osteoarthristis
• Interventions: Drug: Bisphosphonates; Other: Control

• Registration Number: NCT06621069
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2024-06-01
• Primary Completion: 2024-07-01
• Status Verified: 2024-08
• Study Completion: 2024-08-01
• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with over 5-year BP history	Bisphosphonates	patients who took bisphosphonates over 5 years
control patients without BP usage	Control	patients who do not receive bisphosphonates therapy

Primary Outcome Measures

Name	Time	Method
femoral lateral bowing	through study completion, an average of 8 years	Angle between axes of 20% proximal and distal sections of femur diaphysis

Secondary Outcome Measures

Name	Time	Method
femoral neck shaft angle (FNSA)	through study completion, an average of 8 year	Angle between the femoral neck axis and mechanical axis of the femur
hip knee shaft angle	through study completion, an average of 8 years	Angle between mechanical and anatomical femoral axes

Trial Locations

Locations (1)

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