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ALENDRONATE SODIUM TRIHYDRATE

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.

Table of contents

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.[1][2] The studies are looking at fracture prevention and how this treatment compares with other bone medicines or standard care.[1][2]

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.[1][2] One study is completed, and the other is authorised.[1][2]

Study populations and who may take part

One trial studied people with osteogenesis imperfecta, a condition where bones break more easily than normal.[1] This trial planned to include 360 participants.[1]

The other trial studied women over 65 years old with a recent clinical vertebral fracture or recent hip fracture caused by bone fragility.[2] The study description calls this an imminent risk of fracture, which means the person is at very high short-term risk of another fracture.[2] This trial planned to enroll 127 participants.[2]

Trial design and phases

Both studies are interventional, meaning researchers assign treatments and compare outcomes.[1][2] 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.[1]

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.[2] It compares biosimilar teriparatide with ALENDRONATE SODIUM TRIHYDRATE over 52 weeks.[2]

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.[2]

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.[1] This study is event driven, meaning it will end when a set number of fracture events have happened.[1] The study was expected to finish after an average follow-up of 62 months, once 139 participants had experienced a fracture.[1]

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.[2] This outcome focuses on whether the spine fracture is new or becomes more severe over time.[2]

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.[1] Its main goal was to measure clinical fractures confirmed by imaging, with a long follow-up period and an event-driven end point.[1]

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.[2] It is a Phase 3 authorised study with 127 planned participants and a 52-week primary evaluation period.[2]

Key terms explained

Vertebral fracture means a break in a spine bone.[2] Clinical fracture means a fracture that is found because of symptoms and then confirmed by imaging, such as X-ray.[1]

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.[1] Randomized means treatment is assigned by chance, which helps compare groups fairly.[2]

Multicentre means the study is run at more than one hospital or clinic.[2] Follow-up is the time researchers keep track of participants after treatment begins.[1][2]

Trial IDPhaseCondition studiedStatusEnrollment
2024-519705-36-00Phase 3Osteogenesis imperfectaCompleted360
2025-521301-40-00Phase 3Prevention of new morphometric vertebral fractures and/or worsening of previous vertebral fracturesAuthorised127

FAQ

  • What are the clinical trials of ALENDRONATE SODIUM TRIHYDRATE studying? The trials are studying fracture prevention in people with weak or fragile bones. One study compares ALENDRONATE SODIUM TRIHYDRATE with teriparatide in women at high risk of vertebral and hip fractures.
  • Who may take part in these trials? The target groups include women over 65 years old with a recent vertebral fracture or hip fracture caused by bone fragility, and people with osteogenesis imperfecta in another study. Each trial has its own entry rules.
  • What phase are these trials? Both trials listed are Phase 3 studies. Phase 3 trials compare treatments in larger groups to see how well they work in real patient groups.
  • What outcomes are being measured? The main outcomes are the number of new fractures and the worsening of existing vertebral fractures. One study also uses x-ray or other imaging to confirm fractures.
  • Is ALENDRONATE SODIUM TRIHYDRATE being studied alone or with other treatments? In the listed trials, it is studied as one treatment option compared with other bone medicines. The studies are designed to see how it performs against standard care or teriparatide.

Ongoing Clinical Trials on ALENDRONATE SODIUM TRIHYDRATE

  • Study Comparing Teriparatide and Alendronate for Preventing Bone Fractures in Women Over 65 with Fragile Bones

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    Spain

  • Study on Treating Osteogenesis Imperfecta in Patients Using Teriparatide and Zoledronic Acid

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Ireland The Netherlands

Glossary

  • Osteogenesis imperfecta: A genetic condition that makes bones break more easily than normal.
  • Bone fragility: A condition where bones are weak and can fracture more easily.
  • Vertebral fracture: A break in one of the bones of the spine.
  • Morphometric vertebral fracture: A spine fracture seen and measured on an X-ray, even if the symptoms are not obvious.
  • Incident fracture: A new fracture that happens during a study.
  • Re-fracture: A fracture that gets worse or breaks again in a bone that was already broken.
  • Phase 3: A later stage of clinical research that tests how well a treatment works in larger groups.
  • Interventional study: A study where researchers give a treatment and compare the results with another treatment or care plan.
  • Enrollment: The number of people planned to join a study.
  • Primary outcome: The main result that a study is designed to measure.
  • X-ray or other imaging: Tests that let doctors look at bones and confirm whether a fracture has happened.
  • Standard care: The usual treatment people would normally receive outside the study.

References

  1. https://clinicaltrials.gov/study/2024-519705-36-00
  2. https://clinicaltrials.gov/study/2025-521301-40-00