In short
Clinical trials of ALENDRONATE SODIUM TRIHYDRATE are studying how it is used in people with bone fragility and fracture risk. These studies look at whether it helps prevent new fractures and how it compares with other treatments in older adults and people with osteogenesis imperfecta.
Key points
- Clinical trials of ALENDRONATE SODIUM TRIHYDRATE are focused on bone fragility and fracture prevention. The listed studies are both Phase 3 and include people with osteogenesis imperfecta and older women at high risk of spine or hip fractures. One trial compares treatment approaches over a long follow-up period, while another looks at fracture prevention over 52 weeks. The main results being measured are new fractures, worsening of old vertebral fractures, and fractures confirmed by imaging. These trials are designed to see how ALENDRONATE SODIUM TRIHYDRATE performs in real patient groups with a high risk of breaking bones.
Trial overview
Clinical trials of ALENDRONATE SODIUM TRIHYDRATE in the source data are focused on people with fragile bones and a high risk of fractures. The studies are looking at fracture prevention and how this treatment compares with other bone medicines or standard care.
Both listed studies are Phase 3 trials, which means they are later-stage studies that test how well a treatment works in larger patient groups. One study is completed, and the other is authorised.
Study populations and who may take part
One trial studied people with osteogenesis imperfecta, a condition where bones break more easily than normal. This trial planned to include 360 participants.
The other trial studied women over 65 years old with a recent clinical vertebral fracture or recent hip fracture caused by bone fragility. The study description calls this an imminent risk of fracture, which means the person is at very high short-term risk of another fracture. This trial planned to enroll 127 participants.
Trial design and phases
Both studies are interventional, meaning researchers assign treatments and compare outcomes. The osteogenesis imperfecta study compares a treatment plan with teriparatide followed by zoledronic acid against standard care, which may include no active treatment or bisphosphonates depending on usual care choices.
The second study is a prospective, randomized, multicentre study, which means it follows participants forward in time, assigns treatment by chance, and takes place at more than one center. It compares biosimilar teriparatide with ALENDRONATE SODIUM TRIHYDRATE over 52 weeks.
In the second trial, the fracture grading method is the Genant semi-quantitative method, a standard way to measure and classify spine fractures on thoracic and lumbar radiographs, which are X-rays of the middle and lower back.
Main outcomes being measured
The main outcome in the osteogenesis imperfecta trial is the proportion of participants who experience a clinical fracture confirmed by X-ray or other imaging. This study is event driven, meaning it will end when a set number of fracture events have happened. The study was expected to finish after an average follow-up of 62 months, once 139 participants had experienced a fracture.
The main outcome in the second trial is the percentage of patients with at least one new morphometric vertebral fracture or worsening of a known vertebral fracture during the 52-week study period. This outcome focuses on whether the spine fracture is new or becomes more severe over time.
Trial-by-trial summary
Trial 2024-519705-36-00 studied osteogenesis imperfecta in a Phase 3 interventional design with 360 planned participants and a completed status. Its main goal was to measure clinical fractures confirmed by imaging, with a long follow-up period and an event-driven end point.
Trial 2025-521301-40-00 studied prevention of new morphometric vertebral fractures and worsening of previous vertebral fractures in women over 65 with recent vertebral or hip fracture caused by bone fragility. It is a Phase 3 authorised study with 127 planned participants and a 52-week primary evaluation period.
Key terms explained
Vertebral fracture means a break in a spine bone. Clinical fracture means a fracture that is found because of symptoms and then confirmed by imaging, such as X-ray.
Bisphosphonates are mentioned in the trial data as part of standard care options in one study, but the source does not give more detail about them. Randomized means treatment is assigned by chance, which helps compare groups fairly.
Multicentre means the study is run at more than one hospital or clinic. Follow-up is the time researchers keep track of participants after treatment begins.