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

• Status: Terminated
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The overall purpose of this study is to test the individual and combined effect of transdermal testosterone and/or Vitamin D in reducing fall risk and improve function in pre-frail hypogonadal senior men.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Collaborators: Besins Healthcare (funding: investigator-initiated and independent grant); Cantonal Hospital of St. Gallen (PD Dr. Thomas Müntzer); Centre on Ageing and Mobility (Dr. Andreas Egli); Dr. Wild & Co. (funding: investigator-initiated and independent grant); Swiss National Science Foundation; Swiss National Science Foundation (funding: primary funding source); Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging; University Hospital of Zurich, Dept. of Geriatrics (Prof. Robert Theiler, Dr. Gregor Freystaetter); University Hospital, Zürich
• Treatments: Cholecalciferol; Ergocalciferols; Methyltestosterone; Pharmaceutical Solutions; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate; Vitamin D; Vitamins

Criteria

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