No registrations found.
ID
Source
Brief title
Health condition
Physical frailty
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Isometric Grip Strength;
3. Physical Performance (according to Guralnik).
Secondary outcome
1. 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.
Background summary
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.
Study objective
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.
Study design
N/A
Intervention
Atamestane (100 mg/day), - dehydroepiandrosterone (50 mg/day),
the combined regimen of atamestane (100 mg/day) and dehydroepiandrosterone (50 mg/day).
Department of Internal Medicine,
Molewaterplein 40
A.W. Beld, van den
Molewaterplein 40
Rotterdam 3015 GD
The Netherlands
+31 (0)10 4639222
Department of Internal Medicine,
Molewaterplein 40
A.W. Beld, van den
Molewaterplein 40
Rotterdam 3015 GD
The Netherlands
+31 (0)10 4639222
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL226 |
| NTR-old | NTR263 |
| Other | : ME95159 |
| ISRCTN | ISRCTN72714576 |