Last updated on June 2018

Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pre-frail Seniors | Hypogonadism
  • Age: Between 65 - 100 Years
  • Gender: Male

Inclusion Criteria:

  1. Men with documented total testosterone levels < 11.30 nmol/l
  2. Able to come to the study centre (Community-dwelling or institutionalized)
  3. Age 65+ years
  4. At a higher risk for falling
  5. Body mass index > 18.0 and < 35.0 kg/m2
  6. Understands German in reading and writing plus able to read, understand, and complete questionnaires and tests.
  7. Willingness to limit additional vitamin D3 intake to a maximum of 800 IU per day
  8. Willingness to limit calcium supplement intake to 500 mg/day
  9. Willingness to stop active vitamin D metabolites
  10. Willingness to forgo any additional use/application of testosterone products for the duration of the trial.
  11. Participant understands the study procedures, alternative treatments available and risks involved with the study and voluntarily agrees to participate by giving a written informed consent.
  12. Participant meets the routine clinical laboratory safety screening tests performed at screening visit.
  13. Participant is able and willing to perform all study tests, attend all required office visits, and provide blood and urine samples.
  14. Participant is able to apply the testosterone/placebo gel and is able to drink the vitamin D/placebo solution.
  15. Participant is mentally competent (judicious) defined by having score > 24 on the Folstein's mini mental state examination (MMSE) at the screening visit.

Exclusion Criteria:

  1. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
  2. Treatment with vitamin K-antagonists, insulin, adrenocorticotropic hormone (ACTH), corticosteroid (>5mg/d)
  3. Elevated ( 4.0 ng/ml) prostate-specific antigen levels (at screening) and/or palpable signs of prostate cancer
  4. Palpable signs of breast-cancer
  5. Haemoglobin 100 g/l
  6. Haematocrit 0.50 L/L
  7. Liver function values (alanine aminotransferase, aspartate aminotransferase, Gamma-glutamyl transferase, alkaline phosphatase) more than 3 times the upper limit of normal.
  8. Consumption of >800 IU vitamin D on any day in the 6 months prior to enrolment. Provision: a person can be enrolled as soon as the mean intake in the last 6 months and since the last dose is 800 IU.
  9. Elevated serum calcium 2.60 mmol/l (adjusted for albumin )
  10. Estimated (Cockcroft and Gault formula ) creatinine clearance 30 ml/min
  11. Severe visual or hearing impairment
  12. History of cancer < 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer
  13. Myocardial infarction in the last 3 months, unstable angina pectoris and/or exertional dyspnoea >=NYHA III
  14. Treatment worthy but untreated sleep apnoea or chronic (obstructive) pulmonary disease, epilepsy
  15. Significant end-stage disease, i.e. genitourinary, cardiovascular, hepatic, renal, endocrine, hematologic, psychiatric, or pulmonary disease, which, in the opinion of the investigator, may pose a high risk to the patient or impair the patient's ability to complete the trial or confound the results
  16. Uncontrolled hypertension (blood pressure mm Hg 180 systolic or 110 diastolic)
  17. Alcohol abuse or alcoholic disease
  18. Participation in another interventional research trial within the last 6 months prior to screening
  19. Severe gait impairment, e.g. due to Parkinson's disease or hemiplegia
  20. Previous enrolment into the current study
  21. Enrolment of the investigator, his/her family members, employees and other dependent persons

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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