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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of bone fractures in women over the age of 65 who have experienced a recent fracture due to bone fragility. The study is particularly interested in preventing new fractures in the spine, known as vertebral fractures, or worsening of existing ones. The trial will compare two treatments: a medication called Teriparatide, which is given as an injection, and Alendronate, which is taken as a tablet.

The purpose of the study is to evaluate how effective these treatments are in reducing the risk of new vertebral fractures or the worsening of existing fractures over a period of one year. Participants will receive either Teriparatide or Alendronate and will be monitored for any new fractures or changes in their bone health. The study will also look at other factors such as changes in bone density, pain levels, and overall quality of life during the treatment period.

Participants will be randomly assigned to receive one of the two treatments and will be followed for 52 weeks. Throughout the study, regular check-ups will be conducted to assess the health of the participants' bones and to monitor any side effects or changes in their condition. The goal is to determine which treatment is more effective in preventing fractures in women with fragile bones.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age and recent fracture history through X-ray confirmation of a vertebral or hip fracture within the last three months.

  2. Step 2

    Treatment allocation

    Participants are randomly assigned to one of two treatment groups. One group receives alendronate sodium trihydrate in the form of a 70 mg tablet taken orally once a week. The other group receives teriparatide as a 20 micrograms/80 microliters solution for injection, administered subcutaneously daily using a pre-filled pen.

  3. Step 3

    Treatment period

    The treatment period lasts for 52 weeks (1 year). During this time, participants follow the prescribed medication regimen based on their assigned group.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, participants undergo regular monitoring to assess the occurrence of new vertebral fractures or worsening of existing fractures. This includes periodic X-rays using the Genant semi-quantitative method to evaluate vertebral fractures.

    Additional assessments include monitoring bone mineral density (BMD), vertebral pain using a visual analog scale (VAS), and quality of life through the EQ-5D questionnaire.

  5. Step 5

    Completion and follow-up

    At the end of the 52-week treatment period, a final evaluation is conducted to determine the effectiveness of the treatment in preventing new fractures or worsening of existing fractures.

    Participants may be asked to provide feedback on their adherence to the treatment and any side effects experienced during the study.

Who can join the trial?

3 criteria

  • Must be a woman older than 65 years.
  • Must have had a recent clinical vertebral fragility fracture, which is a type of bone break in the spine due to weak bones, confirmed by an X-ray, or a recent hip fragility fracture, which is a break in the hip area, within the last 3 months.
  • Must agree to participate in the study by signing a written informed consent, which is a document that explains the study and confirms your willingness to take part.

Who cannot join the trial?

4 criteria

  • Men cannot participate in the study. Only women are eligible.
  • Women under the age of 65 cannot participate. Only women over 65 are eligible.
  • Individuals who have not experienced a recent clinical vertebral fracture or hip fracture due to **bone fragility** cannot participate. **Bone fragility** means that the bones are weak and more likely to break.
  • Individuals who are part of a vulnerable population cannot participate. A **vulnerable population** includes groups of people who may need special protection or care.
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Investigated drugs

  • Teriparatide (Biosimilar)

    is a medication used in this study to help strengthen bones and reduce the risk of fractures. It works by stimulating bone growth, which can help prevent new fractures and worsening of existing fractures in women with fragile bones.

  • Alendronate

    is another medication used in the study to help prevent bone loss. It works by slowing down the process that breaks down bone, which can help maintain bone strength and reduce the risk of fractures in women with fragile bones.

What is already known about the treatment

  • Teriparatide

    This medication is administered via injection and is used to treat osteoporosis by stimulating new bone growth. It is currently being studied in clinical trials to assess its effectiveness in preventing new vertebral fractures and worsening of existing fractures in women with bone fragility. Teriparatide works by mimicking the action of parathyroid hormone, which increases bone formation by stimulating osteoblast activity. It is classified as an anabolic (bone-building) agent.

  • Alendronate

    This medication is taken orally and is used to prevent and treat osteoporosis by slowing bone loss. It is part of ongoing clinical trials to compare its efficacy with teriparatide in reducing vertebral fractures in women with fragile bones. Alendronate works by inhibiting osteoclast-mediated bone resorption, which helps maintain or increase bone density. It belongs to the class of drugs known as bisphosphonates.

Investigated diseases

Vertebral Fracture – A vertebral fracture occurs when one of the bones in the spine collapses or breaks. This can happen due to weakened bones, often from conditions like osteoporosis, or from trauma. The fracture can lead to back pain, loss of height, and a hunched posture. Over time, multiple fractures can cause significant changes in the spine's shape and function. The condition can progress with additional fractures, leading to increased pain and further spinal deformity. Monitoring and managing bone health is crucial to prevent further fractures.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2025-521301-40-00Estimated enrolment127 patientsSponsorGedeon Richter Iberica S.A.

sourced from the EU Clinical Trials Register and site verification

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