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PRA-XTABHQ02-0D1UOX

Osteoporosis

  • M
  • 25 - 55 years old
  • Healthy

Clinical trial of a new compound that is being developed for the treatment of bone conditions such as osteoporosis

  • From July 2024
  • 3 days
  • 16 visits

€6373,-

Very positive experience, with a very professional staff.

Sven

Deelnemer ICON

Find out if you qualify for this trial

  • You are a healthy male
  • You are between 25 and 55 years old
  • You weigh between 50 and 110 kg
  • Your Body Mass Index (BMI) is between 18 and 32.9 kg/m2

Good to know about this trial

  • The study compound is comparable to the approved drug Prolia. Prolia is already used by patients to treat osteoporosis. In this study we compare the research drug with Prolia.
  • The study only has one short stay period (3 days, 2 nights), the remainder of the study consists of short visits lasting approximately one hour.
  • You can participate in a group in Groningen or in Utrecht. Note: period of stay + the first short visit always take place in Groningen.
  • After the 10th short visit, you will receive half of the reimbursement.

 

How does it work

How does it work?

Read more

Study groups

Register without obligation for the group of your preference

THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH

Additional information

  • The study compound is a new product that may potentially be used for the treatment of osteoporosis and other bone loss associated conditions. Osteoporosis is a disease that weakens the bones. It makes bones thinner and less dense than they should be. People with osteoporosis are more likely to experience broken bones.
  • The study compound is similar to the approved medicine Prolia. Prolia is already being used by patients for the treatment of osteoporosis. In this trial we will compare the study compound to Prolia. The purpose of this trial is to compare how quickly and to what extent the study compound and Prolia are absorbed, broken down, and eliminated from the body.
  • For this study you will need to have an adequate vitamin D level at screening. If your vitamin D level is too low to qualify, you may be given a supplement in order to replenish your vitamin D.

WHO CAN PARTICIPATE?

Target group

  • You are a healthy male.
  • You are at least 25 and at most 55 years old.
  • Your weight is at least 50 kg and at most 110 kg and your Body Mass Index (BMI) is higher than or equal to 18.0 and lower than or equal to 32.9 kg/m2
  • Both non-smokers and smokers (maximum of 10 cigarettes per day, 2 cigars or 2 pipes per day) are allowed to participate in this clinical trial. During the visits in our research facility you are not allowed to smoke.

Note:

  • You cannot participate in the trial if you have participated in another clinical trial in the 2 months prior to the first compound administration in this clinical trial (counting from the last compound administration in the previous trial).
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

You can only participate if you meet one of the following conditions:

  • You are using a condom in combination with an additional contraception method used by your female partner;
  • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

  • You will receive a gross compensation of € 6.373 for participation in this trial. Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation.

HOW LONG DOES THIS RESEARCH TAKE?

Period of stay and research

  • The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 3 days (2 nights), followed by a total of 16 additional visits. The follow-up visit will take place during the last visit.

 

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website.

More information

Veelgestelde vragen

Je mag maximaal 4 keer per jaar deelnemen aan een onderzoek. Tussen twee onderzoeken moeten minstens 30 dagen zitten. Voor sommige onderzoeken geldt een langere wachttijd.

Je kunt tijdens het onderzoek last krijgen van milde klachten als hoofdpijn of misselijkheid. Dat kan door het geneesmiddel komen. Maar het kan ook komen doordat je voor het onderzoek bijvoorbeeld nuchter moet blijven. Die bijwerkingen zijn vervelend, maar gelukkig niet gevaarlijk.

Voordat een geneesmiddel op mensen mag worden getest, is het al uitgebreid onderzocht in een laboratorium. Daardoor kunnen we goed voorspellen welke bijwerkingen je eventueel kunt krijgen en kunnen we je daarop voorbereiden. Het komt dus bijna nooit voor dat deelnemers last krijgen van onverwachte bijwerkingen. Een allergische reactie op het middel komt gemiddeld bijvoorbeeld één keer per jaar voor.

Je deelname aan geneesmiddelenonderzoek is altijd vrijwillig. Je mag dus op elk moment besluiten om te stoppen. Soms ben je genoodzaakt om te stoppen. Bijvoorbeeld vanwege familieomstandigheden, of als de arts besluit dat dat voor jouw gezondheid beter is. Als je stopt, bekijken we op welk deel van de vergoeding je recht hebt. Wel zo eerlijk!

Als je meedoet aan een onderzoek waarvoor je langer dan 10 dagen in het onderzoekscentrum verblijft, is het soms mogelijk om (in overleg) bezoek te ontvangen.

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