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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Hospital Universitario Rio Hortega	Valladolid	Spain
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hospital De Merida	Merida	Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Hospital General Universitario De Castellon	Castello De La Plana	Spain
Hospital General Universitario De Ciudad Real	Ciudad Real	Spain
Pxag Tvjwc Htpfqvev Utgobvtuyyvi	Sabadell	Spain
Hhwgbalo Do Ls Sthmf Cjdh I Sttr Poq	Barcelona	Spain
Fggwsubjt Pzil Lu Iucpxbdkwlvnj Bmvzspuop Daj Hjbvluzi Unpzckyibghur Lh Pgg	Madrid	Spain
Hyysenbv Vbdk dotlrrhw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.09.2021

Trial locations

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.

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 ID:

2025-521301-40-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?