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

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.

Conditions

• Hypogonadism
• Pre-frail Seniors

Interventions

DRUG

Testosterone

transdermal gel, 75 mg daily

DRUG

Colecalciferol

drink solution, 24000 IU once per month

DRUG

Placebo drink solution

drink solution, 0 IU Colecalciferol once per month

DRUG

Placebo transdermal gel

transdermal gel, 0 mg testosterone daily

Sponsors & Collaborators

• Swiss National Science Foundation

  collaborator OTHER

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

  collaborator UNKNOWN

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

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging

  collaborator OTHER

• Centre on Ageing and Mobility (Dr. Andreas Egli)

  collaborator UNKNOWN

• University Hospital, Zürich

  collaborator OTHER

• University of Zurich

  lead OTHER

Principal Investigators

• Heike A Bischoff-Ferrari, MD, DrPH · University of Zurich

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

65 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2020-05-31

Completion

2020-06-30

Countries

• Switzerland

Study Locations