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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06621069

Enrollment

140

Registered

2024-10-01

Start date

2024-06-01

Completion date

2024-08-01

Last updated

2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Knee Osteoarthristis

Keywords

bisphosphonates, atypical femur fracture

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.

Interventions

DRUGBisphosphonates

Alendronate Sodium or Zoledronic acid

OTHERControl

control without BP

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026