Condition category
Not Applicable
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A W van den Beld

ORCID ID

Contact details

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

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

http://www.erasmusmc.nl/

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

Publication citations

Additional files

Editorial Notes