Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ME95159; NTR263
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Randomised, double blind, placebo controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Atamestane, dehydroepiandrosterone
Primary outcome measures
1. Isometric grip strength
2. Leg extension power
3. Physical performance (according to Guralnik)
Secondary outcome measures
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
Overall trial start date
01/01/1996
Overall trial end date
31/08/1997
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Male
Target number of participants
100
Participant 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
Recruitment start date
01/01/1996
Recruitment end date
31/08/1997
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Amsterdam
3015 GD
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Schering AG (Germany) - Strategic Business Unit Fertility Control and Hormone Therapy (SBU FC/HT)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary