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Alendronic Acid

Clinical trials investigating Alendronic Acid are studying its role in people with osteoporosis. These studies look at whether stopping treatment changes fracture risk and measure how well the research works in large patient groups. The main focus is on safety and effectiveness in adults with osteoporosis.

Table of Contents

Trial overview

The source data include one authorised clinical trial called ALEXIS, which is studying people with osteoporosis.[1]

This study is investigating the effect on fracture risk of discontinuing alendronate, and it is described as a randomized controlled study.[1]

Study design and phase

The trial is an interventional study, which means researchers are assigning the study treatment plan rather than just observing what happens naturally.[1]

It is in Phase 3, which is a later research stage used to test how well a treatment strategy works in a larger group of people.[1]

The planned enrollment is 1400 participants, showing that this is a large study.[1]

Who can participate

The trial targets people with osteoporosis.[1]

The data do not provide more detailed entry rules, such as age limits or other health requirements, so the main known target group is adults with this bone condition.[1]

What is being measured

The primary outcome is the incidence of fragility fractures during the study period.[1]

This means the researchers are counting how often weak-bone fractures happen while people are being followed in the trial.[1]

Because the study looks at fracture risk after stopping alendronate, the main question is whether changing treatment affects the chance of these fractures.[1]

Trial treatments listed in the data

The intervention list includes ALENDRONIC ACID and TETRACYCLINE.[1]

The data show ALENDRONIC ACID as 10 mg oral use, and TETRACYCLINE as 1000 mg oral.[1]

The brief summary specifically says the study investigates the effect on fracture risk of discontinuing alendronate, so the treatment question is about stopping therapy rather than starting a new one.[1]

Why this trial matters

People with osteoporosis have a higher risk of bone fractures, so studies that measure fragility fractures are important for understanding long-term care choices.[1]

This trial may help show whether stopping treatment changes fracture risk in a large, controlled research setting.[1]

Because the study is authorised and in Phase 3, it is one of the more advanced types of clinical research in the source data.[1]

Trial ID Phase Condition studied Status Enrollment
2023-510042-24-01 Phase 3 Osteoporosis Authorised 1400

FAQ

  • What is being studied in trials of Alendronic Acid? The trial data focus on whether stopping alendronate changes the risk of fragility fractures. A fragility fracture is a break that can happen after a small fall or minor injury.
  • Who may be included in these trials? The main target group is people with osteoporosis. The study is designed for a large group of participants, with an enrollment of 1400.
  • What phase is the Alendronic Acid trial? The trial is in Phase 3. This means it is a later-stage study that checks how well the treatment strategy works in a larger group of people.
  • What outcome is the trial measuring? The main outcome is the incidence of fragility fractures during the study period. This means the researchers count how often these fractures happen over time.
  • Is the study testing Alendronic Acid alone? The trial includes Alendronic Acid and also TETRACYCLINE as listed in the study data. The brief summary says the study is randomized and looks at the effect of discontinuing alendronate.

Ongoing Clinical Trials on Alendronic Acid

  • Study on the Effects of Stopping Alendronic Acid in Patients with Osteoporosis

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Osteoporosis: A condition where bones become weaker and can break more easily.
  • Fragility fracture: A bone break that happens after a small fall, a minor injury, or even normal daily activity.
  • Phase 3: A late stage of clinical research that tests how well a study treatment strategy works in a larger group of people.
  • Interventional study: A trial where researchers assign a treatment or study plan to see what happens.
  • Randomized controlled study: A study that puts participants into groups by chance and compares the results between them.
  • Enrollment: The number of people planned to join the study.
  • Primary outcome: The main result the researchers want to measure.
  • Incidence: How often a new event happens during the study.
  • Study period: The time during which the trial follows participants.
  • Discontinuing: Stopping a treatment.

References

  1. https://clinicaltrials.gov/study/2023-510042-24-01