Clinical Trials for Bone Metabolism Disorder
There is currently 1 ongoing clinical trial for Bone Metabolism Disorder, focused on preventing bone fractures in women over 65 with fragile bones. The trial compares two different medications to determine which is more effective in reducing the risk of new fractures in the spine.
Clinical trial locations
Study Comparing Teriparatide and Alendronate for Preventing Bone Fractures in Women Over 65 with Fragile Bones
This clinical trial is being conducted in Spain and focuses on preventing bone fractures in women who have recently experienced a fracture due to fragile bones. The study specifically targets women over the age of 65 who have had a recent vertebral fracture (a break in the spine) or hip fracture within the last three months.
Main inclusion criteria:
- Must be a woman older than 65 years
- Must have experienced a recent vertebral or hip fragility fracture confirmed by X-ray within the last 3 months
- Must agree to participate and sign an informed consent document
Main exclusion criteria:
- Men are not eligible for this study
- Women under 65 years of age cannot participate
- Individuals who have not had a recent vertebral or hip fracture due to bone fragility
- People who belong to vulnerable populations requiring special protection
Focus and goal of the trial:
The primary goal of this study is to evaluate how effective two different treatments are in preventing new vertebral fractures or the worsening of existing fractures over a one-year period. Participants are randomly assigned to receive either Teriparatide or Alendronate and are monitored throughout the 52-week treatment period. The study also examines other important factors such as changes in bone density, pain levels measured using a visual analog scale, and overall quality of life through questionnaires. Regular check-ups and periodic X-rays are conducted to assess bone health and monitor for any new fractures or side effects.
Investigational drugs:
The trial compares two medications:
- Teriparatide (Biosimilar) – This medication is given as a daily injection under the skin using a pre-filled pen. The dose is 20 micrograms per injection. Teriparatide works by stimulating bone growth, helping to strengthen bones and reduce the risk of fractures. It mimics the action of parathyroid hormone and increases bone formation by stimulating the cells that build new bone.
- Alendronate – This medication is taken as a 70 mg tablet by mouth once a week. Alendronate works by slowing down the process that breaks down bone, helping to maintain bone strength and density. It belongs to a class of drugs called bisphosphonates that prevent bone loss.
Summary
Currently, there is one active clinical trial for bone metabolism disorder, taking place in Spain. This trial specifically focuses on postmenopausal women over 65 with recent fragility fractures, comparing two established bone-strengthening approaches: an anabolic agent (Teriparatide) that builds new bone versus an anti-resorptive agent (Alendronate) that prevents bone loss. The study aims to determine which treatment strategy is more effective in preventing new vertebral fractures over the course of one year. This targeted research reflects the ongoing effort to optimize treatment strategies for women with severe bone fragility following recent fractures.