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Zoetermeer Study.


- candidate number1454
- NTR NumberNTR263
- ISRCTNISRCTN72714576
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR7-sep-2005
- Secondary IDsME95159 
- Public TitleZoetermeer Study.
- Scientific TitleDouble-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.
- ACRONYMN/A
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedPhysical frailty
- Inclusion criteria1. 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.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-1996
- planned closingdate31-aug-1997
- Target number of participants100
- InterventionsAtamestane (100 mg/day), - dehydroepiandrosterone (50 mg/day), the combined regimen of atamestane (100 mg/day) and dehydroepiandrosterone (50 mg/day).
- Primary outcome1. Isometric Grip Strength;
3. Physical Performance (according to Guralnik).
- Secondary outcome1. Activities od Daily Living;
2. Fragen of LiebensZufriedenheid (quality of life);
3. Mini Mental State examination;
4. Body composition;
5. Bone density of hip;
6. Bone metabolism;
7. Hormonal parameters total testosterone, DHEA, DHEA-S, estradiol, estrone, SHBG, IGF-1, IGFBP, IGFBP3;
8. Glucose, insulin HbA1c;
9. Immunological parameters (lymphocyte sub-populations and surface markers);
10. Lipid metabolism (HDL, LDL, triglycerides, cholesterol);
11. Carotid intima-media thickness.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. A.W. Beld, van den
- CONTACT for SCIENTIFIC QUERIESProf. Dr. S.W.J. Lamberts
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Schering Berlin, SBU FC & HT/Department HT
- PublicationsJ Clin Endocrinol Metab. 2006 Oct;91(10):3988-91. Epub 2006 Jun 27.
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD8-sep-2005 - 14-aug-2008


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