Study on the Effects of Somatropin and Letrozole in Boys with Short Predicted Height

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What is this study about?

This clinical trial is focused on boys with a condition known as short predicted height, which means they are expected to be shorter than average when they grow up. The study is examining the effects of two treatments: Omnitrope, which is a form of growth hormone, and Letrozole, an aromatase inhibitor. Aromatase inhibitors are medications that can help increase height by affecting hormone levels during puberty.

The purpose of the study is to see if boys who receive a combination of both Omnitrope and Letrozole during puberty will grow taller than those who receive only Omnitrope. The study will last for four years, during which participants will receive their assigned treatment. The growth of the boys will be monitored to determine if the combination therapy leads to a greater increase in height compared to the growth hormone alone.

Participants in the study will receive their treatments either as a solution for injection in the case of Omnitrope or as film-coated tablets for Letrozole. The study aims to provide valuable information on the effectiveness and safety of these treatments in helping boys with short predicted height achieve a taller adult height.

1 initiation of treatment

The treatment begins with the administration of growth hormone (Omnitrope) and possibly an aromatase inhibitor (Letrozole).

Omnitrope is provided as a solution for injection and is administered through a subcutaneous injection. The dosage and frequency are determined by the healthcare provider.

Letrozole is provided in the form of film-coated tablets and is taken orally. The dosage and frequency are determined by the healthcare provider.

2 treatment duration

The treatment is planned to last for a period of 4 years.

The objective is to evaluate the increase in adult height compared to the predicted height at the start of the treatment.

3 monitoring and assessments

Regular monitoring and assessments are conducted to evaluate the progress of the treatment.

These assessments may include measuring height, monitoring bone age, and evaluating any side effects of the medications.

4 completion of treatment

At the end of the 4-year treatment period, a final assessment is conducted to determine the adult height gain.

The final height is compared to the predicted adult height to evaluate the effectiveness of the treatment.

Who Can Join the Study?

  • Must be of male gender.
  • Have a predicted adult height that is below or equal to -2.5 standard deviations, which means less than 164.0 cm, based on a specific growth chart.
  • Must be in puberty, which is shown by having at least 4 ml of testicular volume.
  • Have a bone age between 11 and 13 years. Bone age is a way to measure how mature the bones are.
  • Must have signed informed consent, meaning they agree to participate in the study after understanding what it involves.

Who Cannot Join the Study?

  • Only boys can participate in the study. Girls are not eligible.
  • Participants must be at the beginning of puberty. If puberty has not started or is already advanced, they cannot join the study.
  • The study is for boys with a short predicted height. If a boy’s predicted adult height is not considered short, he cannot participate.
  • Participants should not belong to any vulnerable population. This means they should not be in a group that needs 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 Status
Uowftlblaj Or Ahcrqzx Edegem Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
03.03.2012

Trial locations

Investigated drugs:

Omnitrope is a growth hormone used in this study to help boys with a short predicted height grow taller. It is given to support their natural growth processes during puberty.

Letrozole is an aromatase inhibitor used in combination with growth hormone in this study. It works by reducing the levels of estrogen in the body, which can help increase the effectiveness of the growth hormone therapy in promoting height growth.

Investigated diseases:

Short Stature – Short stature refers to a condition where an individual’s height is significantly below the average for their age and gender. It can be due to genetic factors, hormonal imbalances, or other underlying health issues. In children, it often becomes noticeable when they fall below the growth curve on standard growth charts. The condition may progress as the child continues to grow at a slower rate compared to peers. It is important to monitor growth patterns over time to determine if the short stature is part of a normal variation or indicative of a medical condition.

Trial ID:
2024-519935-41-00
Protocol code:
BSGPE2
Trial Phase:
Therapeutic confirmatory (Phase III)

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