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NCT Number: NCT06621069

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Knee Osteoarthristis Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hangzhou, Zhejiang, 310058, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bisphosphonates

Drug

Alendronate Sodium or Zoledronic acid

Control

Other

control without BP

Primary outcomes

  1. 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

  1. femoral neck shaft angle (FNSA)

    Time frame: through study completion, an average of 8 year

    Angle between the femoral neck axis and mechanical axis of the femur

  2. hip knee shaft angle

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

    Angle between mechanical and anatomical femoral axes

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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