Het onderzoek

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

  • 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.

Periode

  • 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.

Vergoeding

  • 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.

Overige informatie

  • 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.
Wallet

Wil je meedoen aan dit onderzoek?

Dat kan! Vul je gegevens in via dit aanmeldformulier. Het onderzoekscentrum dat dit onderzoek uitvoert zal vervolgens contact met je opnemen over je mogelijke deelname.

Ik wil meedoen

Let op: Voor deelnemers die roken; maximaal 10 sigaretten per dag.