RecruitingRare disease

Study on Losartan and Hydrochlorothiazide for Osteogenesis Imperfecta in Patients Aged 16 and Above

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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 a condition known as Osteogenesis Imperfecta, which is a genetic disorder characterized by fragile bones that break easily. The study aims to explore the effects of a treatment using a medication called Losartan, which is commonly used to treat high blood pressure but is being investigated here for its potential benefits in reducing bone fragility in individuals with Osteogenesis Imperfecta.

The purpose of the study is to determine the most effective dose of Losartan for patients aged 16 and older with Osteogenesis Imperfecta. Participants will receive the medication over a period of six months. During this time, researchers will monitor changes in a specific marker related to bone health, known as the carboxy-terminal crosslink of type I collagen telopeptide (CTX), to assess how well the treatment is working.

Throughout the study, participants will undergo regular check-ups to track their progress and any changes in their condition. The study will also evaluate other health indicators, such as quality of life and physical function, to gain a comprehensive understanding of the treatment's impact. This research is important for finding new ways to improve the lives of those living with Osteogenesis Imperfecta.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
The study begins with an initial assessment to confirm eligibility. This includes verifying age (16 years and above) and diagnosis of osteogenesis imperfecta.
Previous treatments are reviewed to ensure compliance with washout periods for bisphosphonates and denosumab.
Step 2
Baseline measurements
Baseline measurements are taken, including the bone resorption marker CTX (carboxy-terminal crosslink of type I collagen telopeptide), and other markers such as TGFβ and P1NP.
Additional assessments include DXA (dual-energy X-ray absorptiometry) for bone density, and HRpQCT (high-resolution peripheral quantitative computed tomography) for bone structure.
Step 3
Medication administration
The medication losartan is administered orally. The dosage and frequency are determined based on the study protocol.
The goal is to establish the effective dose for reducing the bone resorption marker CTX.
Step 4
Follow-up assessments
Follow-up assessments occur at week 8 and week 24 to measure changes in CTX, TGFβ, and P1NP.
Additional evaluations include changes in bone density and structure, as well as physical performance using the Timed Up and Go test.
Step 5
Quality of life evaluation
Quality of life is assessed using the OI-QOL (Osteogenesis Imperfecta Quality of Life) and EQ-5D-5L-VAS (EuroQol 5-Dimension 5-Level Visual Analogue Scale) from baseline to week 24.
Step 6
Study completion
The study is estimated to end by December 1, 2026. Final assessments are conducted to evaluate the overall effectiveness of the treatment.

Who can join the trial?

11 criteria

Must be **16 years or older**.
Can have had more than **6 weeks of oral bisphosphonate therapy** or more than one single intravenous bisphosphonate treatment, as long as it was **10 years ago**.
Must not be eligible for certain treatments or not have access to them, like **neridronate** in Italy.
Can have had more than one dose of **denosumab**, as long as it was **1 year ago**.
Must be diagnosed with **osteogenesis imperfecta** (any type).
Can have had up to **6 weeks of oral bisphosphonate therapy**, as long as it was **12 months ago**.
Can have had a single dose of an intravenous bisphosphonate, as long as it was **18 months ago**.
If a woman can have children, she must agree to use an effective method of **birth control** during the study.
Must agree not to join another research project while participating in this study.
Must not be taking any medications that are not allowed in the study.
Must not have any other health issues that would make it unsafe to participate, according to the study doctor.

Who cannot join the trial?

8 criteria

Patients who are under 16 years old cannot participate.
Patients who are pregnant or breastfeeding are not allowed to join the study.
Patients with severe kidney or liver problems cannot take part.
Patients who have had a recent heart attack or stroke are excluded.
Patients who are currently taking certain medications that might interfere with the study drug cannot participate.
Patients with a history of allergic reactions to similar medications are not eligible.
Patients who are unable to follow the study procedures or attend study visits are excluded.
Patients with other serious health conditions that might affect the study results cannot join.

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Verified sites

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Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
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Istituto Ortopedico Rizzoli
Bologna, Italy

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Investigated drugs

Losartan is a medication that is being studied for its potential to help patients with Osteogenesis Imperfecta, a condition that affects bone strength. The goal of the study is to find the most effective dose of losartan that can reduce a specific marker in the body related to bone breakdown. This could help improve bone health in patients aged 16 years and older.

What is already known about the treatment

Losartan – Losartan is typically administered orally in tablet form. It is currently being studied in clinical trials for its potential use in treating Osteogenesis Imperfecta, a condition characterized by fragile bones. The main therapeutic indication being explored is its ability to reduce bone resorption, which is a process where bone is broken down and its minerals released into the bloodstream. At the molecular level, Losartan works by blocking the action of a substance in the body called angiotensin II, which helps to relax blood vessels and may also influence bone metabolism. It is classified pharmacologically as an angiotensin II receptor blocker (ARB).

Investigated diseases

Osteogenesis Imperfecta – Osteogenesis Imperfecta is a genetic disorder characterized by fragile bones that break easily, often with little or no apparent cause. It is caused by a defect in the production of collagen, a protein that helps strengthen bones. People with this condition may experience frequent fractures, bone deformities, and short stature. The severity of symptoms can vary widely, with some individuals having only a few fractures in a lifetime, while others may have hundreds. In addition to bone issues, some may have hearing loss, dental problems, and a blue tint to the whites of their eyes. The condition is present from birth and affects individuals throughout their lives.