The study hypothesis is that that daily oral atamestane (100 mg/day), dehydroepiandrosterone (50 mg/day) alone and the combined regimen improve physical frailty, muscle strength and functional performance compared to placebo.
ID
Bron
Verkorte titel
Aandoening
Physical frailty
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Isometric Grip Strength;<br
2. Leg Extension Power;<br>
3. Physical Performance (according to Guralnik).
Achtergrond van het onderzoek
The Zoetermeer Study is double-blind randomised, placebo-controlled clinical study to investigate the effects of daily oral atamestane (100 mg/day) and dehydroepiandrosterone (50 mg/day) alone and in a combined regimen on physical frailty and quality of life in 100 elderly male volunteers over a treatment period of 36 weeks. The trial has been finished, and a study report is in preparation.
Doel van het onderzoek
The study hypothesis is that that daily oral atamestane (100 mg/day), dehydroepiandrosterone (50 mg/day) alone and the combined regimen improve physical frailty, muscle strength and functional performance compared to placebo.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Atamestane (100 mg/day), - dehydroepiandrosterone (50 mg/day),
the combined regimen of atamestane (100 mg/day) and dehydroepiandrosterone (50 mg/day).
Publiek
Department of Internal Medicine,
Molewaterplein 40
A.W. Beld, van den
Molewaterplein 40
Rotterdam 3015 GD
The Netherlands
+31 (0)10 4639222
Wetenschappelijk
Department of Internal Medicine,
Molewaterplein 40
A.W. Beld, van den
Molewaterplein 40
Rotterdam 3015 GD
The Netherlands
+31 (0)10 4639222
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Men;
2. 70 years or older;
3. Participant in previous cross-sectional study among 400 men;
4. Low performance score on IGS and LEP test compared to mean of 400 men in cross-sectional study.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Severe arthropathic deformation of knee joint severly limiting mobility;
2. Severe systemic disease interfering with conduct of study or interpretation of results;
3. Abnormal lab functions from preceding cross-sectional study considered clinically significant and giving suspicion of specific organ dysfunction;
4. Myocardial infarction within 6 months prior to first visit or clinical evidence of congestive heart failure;
5. History of stroke or TIAs;
6. Sitting systolic blood rpessure of 200 mmHg or higher or diastolic blood pressure of 105 mmHg or higher at any of pretreatment visits;
7. Active malignant disease with significant impact of physical condition;
8. History of prostatic cancer;
9. Diabetes mellitus treated with insulin;
10. Preexisting signs of abnormal liver function with clinical significance;
11. History of alcohol abuse within last 2 years;
12. Participation in another clinical trial or systemic administration of an investigational drug within the last 3 months prior to start of study.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL226 |
| NTR-old | NTR263 |
| Ander register | : ME95159 |
| ISRCTN | ISRCTN72714576 |