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

ISRCTN	ISRCTN72714576
DOI	https://doi.org/10.1186/ISRCTN72714576
Protocol serial number	ME95159; NTR263
Sponsor	Erasmus Medical Centre (Netherlands)
Funder	Schering AG (Germany) - Strategic Business Unit Fertility Control and Hormone Therapy (SBU FC/HT)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 17/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A W van den Beld
Scientific

Erasmus Medical Center
Department of Internal Medicine
40 Molewaterplein
Amsterdam
3015 GD
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised, double blind, placebo controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Physical frailty
Intervention	1. Atamestane (100 mg/day) 2. Dehydroepiandrosterone (50 mg/day) 3. Combined regimen of atamestane (100 mg/day) and dehydroepiandrosterone (50 mg/day)
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Atamestane, dehydroepiandrosterone
Primary outcome measure(s)	1. Isometric grip strength 2. Leg extension power 3. Physical performance (according to Guralnik)
Key secondary outcome measure(s)	1. Activities of Daily Living 2. Quality of life 3. Mini Mental State Examination 4. Body composition 5. Bone density of hip 6. Bone metabolism 7. Hormonal parameters total testosterone, dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulphate (DHEAS), oestradiol, oestrone, sex hormone binding globulin (SHBG), insulin-like growth factor 1 (IGF-1), IGF-binding proteins (IGFBP), IGF-binding protein 3 (IGFBP3) 8. Glucose, insulin HbA1c 9. Immunological parameters (lymphocyte sub-populations and surface markers) 10. Lipid metabolism (high density lipoproetin [HDL], low density lipoprotein [LDL], triglycerides, cholesterol) 11. Carotid intima-media thickness
Completion date	31/08/1997

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Male
Target sample size at registration	100
Key inclusion criteria	1. Men 2. 70 years or older 3. Participant in previous cross-sectional study among 400 men 4. Low performance score on isometric grip strength (IGS) and leg extensor power (LEP) test compared to mean of 400 men in cross-sectional study
Key exclusion criteria	1. Severe arthropathic deformation of knee joint severely 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 transient ischaemic attacks (TIAs) 6. Sitting systolic blood pressure 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
Date of first enrolment	01/01/1996
Date of final enrolment	31/08/1997

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medical Center

Amsterdam
3015 GD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan