Table of Contents

• Trial overview
• Conditions and patient groups
• Trial designs and comparison groups
• Outcomes being measured
• Trial-specific highlights
• What these trials aim to answer

Trial overview

The trial data show studies of Zoledronic Acid in bone, fracture, spine, and tendon repair settings.^{[1][2][3][4][5][6][7]}

Across the listed studies, the statuses are Authorised, and the phases include Phase 2, Phase 3, and Low Intervention studies.^{[1][2][3][4][5][6][7]}

The studies are interventional, which means the researchers give a treatment and then measure what happens.^{[1][2][3][4][5][6][7]}

Conditions and patient groups

Several trials focus on osteoporosis, a condition where bones become weak and break more easily.^[1][4]

One study includes people with hip fracture after surgery, while another includes patients with primary hyperparathyroidism around the time of parathyroid surgery.^[2][3]

Another trial studies people with chronic low back pain and Modic changes, which are scan findings linked with back pain.^[5]

One trial is in children or young people with osteogenesis imperfecta, a genetic condition that makes bones break more easily.^[6]

One study looks at people with chronic rotator cuff lesions after shoulder repair, which is a tendon injury in the shoulder.^[7]

One osteoporosis study also focuses on people who previously used denosumab and are being followed after stopping that treatment.^[1]

Trial designs and comparison groups

Some studies compare Zoledronic Acid with a placebo, which is an inactive treatment used for comparison.^[2][5]

Some use saline or electrolytes as the control treatment, so researchers can see whether the active treatment works better than no active drug.^[1][3][5]

The ZEBRA study in hip fracture patients compares early treatment after surgery with later treatment after surgery.^[3]

The osteoporosis study after denosumab discontinuation tests whether repeated infusions at fixed times or based on bone turnover changes may help prevent bone loss.^[1]

The rotator cuff study tests whether adjuvant intravenous therapy improves tendon healing after arthroscopic repair.^[7]

The pediatric osteogenesis imperfecta study compares setrusumab with intravenous bisphosphonates, including Zoledronic Acid among the listed options.^[6]

Outcomes being measured

Several trials measure bone mineral density (BMD), which shows how dense and strong the bone is.^[1][2][4]

Some studies measure bone turnover markers, such as P1NP, which help show how active bone building is.^[3][1]

The low back pain study measures the Oswestry Disability Index (ODI), a score that shows how much back pain affects daily life.^[5]

The hip fracture study uses the proportion of patients with P1NP above a set level after treatment, which is a way to measure bone suppression.^[3]

The rotator cuff study measures tendon integrity, meaning whether the repaired tendon stays intact or tears again.^[7]

The osteogenesis imperfecta study measures the annual rate of confirmed fractures, including vertebral fractures, which are breaks in the bones of the spine.^[6]

Trial-specific highlights

ZOLARMAB2 studies whether multiple infusions after stopping denosumab can prevent rebound bone loss and whether yearly infusions can stop later bone loss from returning.^[1]

The primary hyperparathyroidism trial looks at bone, kidney, and cardiovascular effects one year after surgery when bisphosphonate treatment is given at the time of parathyroidectomy.^[2]

The ZEBRA trial asks whether giving Zoledronic Acid within 5 days after hip fracture surgery is not worse than giving it 3 months later, using a bone marker at 12 months as the main measure.^[3]

The OPTIMIST study is mainly about romosozumab strategies, but it includes Aclasta as one of the treatment options in the study design for osteoporosis.^[4]

The ZAMBA study tests whether two infusions of 5 mg zoledronic acid reduce back-specific disability better than placebo in people with chronic low back pain and Modic changes.^[5]

The COSMIC study in pediatric osteogenesis imperfecta measures fracture reduction across treatment groups that include intravenous bisphosphonates such as Zoledronic Acid.^[6]

The ZORRO trial checks whether adjuvant intravenous Zoledronic Acid improves tendon healing after arthroscopic repair of chronic rotator cuff tears compared with no adjuvant therapy.^[7]

What these trials aim to answer

These trials are trying to find out which patients may benefit from Zoledronic Acid, when it should be given, and what outcome it changes most clearly.^[1][3][5][7]

They also check whether treatment can help prevent bone loss, reduce fractures, improve disability, or support healing after surgery.^{[1][2][3][5][6][7]}

Because the studies use different patient groups and different endpoints, they help build a clearer picture of where this treatment strategy may fit in clinical care.^{[1][2][3][4][5][6][7]}