Zoetermeer Study.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28735

Enrollment

100

Registered

2005-09-07

Start date

1996-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical frailty

Interventions

Atamestane (100 mg/day), - dehydroepiandrosterone (50 mg/day), the combined regimen of atamestane (100 mg/day) and dehydroepiandrosterone (50 mg/day).

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
1. Isometric Grip Strength;<br 2. Leg Extension Power; 3. Physical Performance (according to Guralnik).	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactA.W. Beld, van den

Erasmus Medical Center, Department of Internal Medicine, Molewaterplein 40

+31 (0)10 4639222

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)