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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02419105
• Date of registration: 30/03/2015
• Prospective Registration: Yes
• Primary sponsor: University of Zurich
• Public title: Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors T&D
• Scientific title: Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors. Double Blind, 2x2 Factorial, Randomized Placebo--Controlled Clinical Trial
• Date of first enrolment: September 2015
• Target sample size: 91
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02419105
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Switzerland

Contacts

• Name: Heike A Bischoff-Ferrari, MD, DrPH
• Affiliation: University of Zurich

Key inclusion & exclusion 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



Age minimum: 65 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Pre-frail Seniors

Hypogonadism

Intervention(s)

Drug: Testosterone

Drug: Colecalciferol

Drug: Placebo transdermal gel

Drug: Placebo drink solution

Primary Outcome(s)

Number of fallers [Time Frame: 12 months]

Rate of falls [Time Frame: 12 months]

Secondary Outcome(s)

Appendicular lean skeletal muscle mass (aLSM) [Time Frame: 12 months]

Quality of life [Time Frame: 12 months]

Lower extremity function [Time Frame: 12 months]

Reaction time [Time Frame: 12 months]

Gait Speed [Time Frame: 12 months]

Secondary ID(s)

KEK-ZH-2014-0436

32003B_135192

SNCTP: 000001224

2105DR3024

T&D Study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Swiss National Science Foundation

Centre on Ageing and Mobility (Dr. Andreas Egli)

Cantonal Hospital of St. Gallen (PD Dr. Thomas Müntzer)

Dr. Wild & Co. (funding: investigator-initiated and independent grant)

University Hospital of Zurich, Dept. of Geriatrics (Prof. Robert Theiler, Dr. Gregor Freystaetter)

Besins Healthcare (funding: investigator-initiated and independent grant)

Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging