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This clinical trial is focused on studying the effects of a medication called Zoledronic Acid on the healing process after surgery for a shoulder condition known as a chronic rotator cuff tear. This condition involves a tear in the tendons around the shoulder joint, which can occur due to injury or wear and tear over time. The study also considers patients with osteoporosis, a condition where bones become weak and fragile. The purpose of the study is to see if Zoledronic Acid can help improve the healing of the tendon after it has been repaired through a procedure called arthroscopic surgery, which is a minimally invasive surgery using small incisions and a camera to guide the repair.
Participants in the study will receive either Zoledronic Acid or a placebo, which is a substance with no active medication, to compare the effects. The medication will be given through an infusion, which means it is delivered directly into the bloodstream via a vein. The study will monitor the healing of the tendon using magnetic resonance imaging (MRI), a type of scan that uses magnets and radio waves to create detailed images of the inside of the body. These scans will be done at several points over a period of up to five years after the surgery to assess the integrity of the tendon and see if it has healed properly without re-tearing.
In addition to the primary focus on tendon healing, the study will also look at other factors such as muscle condition, shoulder movement, strength, and pain levels. These will be evaluated using various scores and assessments to provide a comprehensive view of the shoulder's recovery. The study aims to provide valuable insights into whether Zoledronic Acid can be a beneficial addition to the treatment plan for individuals undergoing surgery for chronic rotator cuff tears, particularly those who also have osteoporosis.
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
5 criteria
2 criteria
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This condition occurs when a tendon, which connects muscle to bone, is torn or ruptured. It often results from a sudden injury or overuse, leading to pain, swelling, and difficulty moving the affected area. The severity of the rupture can vary, with partial tears causing less dysfunction than complete tears. Over time, the body attempts to heal the tendon, but the process can be slow and may not fully restore the tendon's original strength or flexibility. Recovery often involves a combination of rest, physical therapy, and gradual return to activity. In some cases, surgical intervention may be necessary to repair the tendon.
This is a condition characterized by weakened bones that become fragile and more likely to fracture. It develops gradually over many years, often without symptoms until a fracture occurs. The disease is most common in older adults, particularly postmenopausal women, due to changes in hormone levels that affect bone density. As bones lose density, they become porous and brittle, increasing the risk of breaks from minor falls or even normal activities. The progression of osteoporosis can lead to a decrease in height, a stooped posture, and persistent back pain due to vertebral fractures. Maintaining bone health through diet and lifestyle is crucial in managing the condition.
Other trials in this disease – keep exploring while you decide
Portugal
France
Spain
The Netherlands
GermanyFrancesourced from the EU Clinical Trials Register and site verification
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