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

NCT06621069 | Completed DMC

• 1 other identifier: 2024-0641
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Knee Osteoarthristis

Keywords

bisphosphonates; atypical femur fracture

Outcome Measures

Primary Outcomes (1)

• femoral lateral bowing

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

  through study completion, an average of 8 years

Secondary Outcomes (2)

• 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 Arms (2)

patients with over 5-year BP history

patients who took bisphosphonates over 5 years

Drug: Bisphosphonates

control patients without BP usage

patients who do not receive bisphosphonates therapy

Other: Control

Interventions

Bisphosphonates DRUG

Alendronate Sodium or Zoledronic acid

patients with over 5-year BP history

Control OTHER

control without BP

control patients without BP usage

Eligibility Criteria

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

Study Population

patients are mostly from Zhejiang Province

You may qualify if:

• standing radiographs of the lower limb

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310058, China

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Diphosphonates

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 1, 2024
• Study Start: June 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-08

Locations

CN (1)