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

September 27, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310058
        • 1. Department of Orthopedics Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

patients are mostly from Zhejiang Province

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with over 5-year BP history
patients who took bisphosphonates over 5 years
Drug: Bisphosphonates
Alendronate Sodium or Zoledronic acid
control patients without BP usage
patients who do not receive bisphosphonates therapy
Other: Control
control without BP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 8 year
hip knee shaft angle
Time Frame: through study completion, an average of 8 years
Angle between mechanical and anatomical femoral axes
through study completion, an average of 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0641

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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