Investigating Alendronate's Effect on Knee Function After ACL Reconstruction
The Effect of Oral Administration of Alendronate on Knee Functions Following Anterior Cruciate Ligament Reconstruction - A Pilot Study of Single-Blind Randomized Controlled Trial
PHASE4 · Chinese University of Hong Kong · NCT05527548
This study is testing if the osteoporosis medication Alendronate can help people aged 18-40 recover better and improve knee function after their first ACL surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Sha Tin) |
| Trial ID | NCT05527548 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of Alendronate, a medication commonly used to treat osteoporosis, on knee function following anterior cruciate ligament reconstruction (ACLR). The study involves male and female participants aged 18-40 who are undergoing their first ACLR and aims to determine if Alendronate can improve recovery outcomes and reduce the risk of post-traumatic osteoarthritis. Participants will be monitored for knee function improvements post-surgery, with a focus on the effectiveness of the intervention in enhancing healing and stability of the knee joint.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-40 who are undergoing their first ACL reconstruction.
Not a fit: Patients with chronic diseases affecting bone metabolism or those with contraindications to Alendronate therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery and knee function for patients undergoing ACL reconstruction.
How similar studies have performed: While the use of Alendronate in this context is novel, similar studies have shown promising results in improving bone health and recovery in other orthopedic settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female with age 18-40 at the time of surgery * First ACLR * Single leg involvement * Able to attend pre-operative assessment * Voluntarily agreed to participate and signed the informed consent form Exclusion Criteria: * Known chronic disease or receiving long-term medications affecting bone metabolism including BPs * Contraindication to alendronate therapy such as poor dental fitness * ACL injury less than 6 weeks * Injury on duty cases * Patients who have undergone arthroscopy or open surgery in the index knee in the last 12 months * Other associated injuries (fractures and other ligament involvement such as neurovascular bundles injury) * Chondral lesion with concomitant intervention * Presence of X-ray features of osteoarthritis including decrease in joint space, presence of osteophytes and subchondral cysts * Neurological deficit * Pregnant or breastfeeding * Inability to give informed consent
Where this trial is running
Sha Tin
- Prince of Wales Hospital — Sha Tin, Hong Kong (RECRUITING)
Study contacts
- Study coordinator: Patrick Shu-hang YUNG
- Email: patrickyung@cuhk.edu.hk
- Phone: +852 3505 2728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ACL Reconstruction