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 |
| Secondary identifying numbers | ME95159; NTR263 |
- 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
Scientific
Erasmus Medical Center
Department of Internal Medicine
40 Molewaterplein
Amsterdam
3015 GD
Netherlands
Study information
| Study design | Randomised, double blind, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Atamestane, dehydroepiandrosterone |
| Primary outcome measure | 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 study start date | 01/01/1996 |
| Completion date | 31/08/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Male |
| Target number of participants | 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
3015 GD
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
University/education
University/education
Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
| Website | http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Industry
Schering AG (Germany) - Strategic Business Unit Fertility Control and Hormone Therapy (SBU FC/HT)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
