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

NCT02419105 | Terminated Phase 3

• 5 other identifiers: T&D Study32003B_135192SNCTP: 000001224KEK-ZH-2014-04362105DR3024
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Falls; hypogonadal men; Seniors; Testosterone; Colecalciferol

Outcome Measures

Primary Outcomes (2)

• Number of fallers

  The participant will fill in a falls diary.

  12 months

• Rate of falls

  The participant will fill in a falls diary.

  12 months

Secondary Outcomes (5)

• Appendicular lean skeletal muscle mass (aLSM)

  12 months

• Lower extremity function

  12 months

• Reaction time

  12 months

• Gait Speed

  12 months

• Quality of life

  12 months

Other Outcomes (9)

• Cognitive function

  12 months

• Body composition

  12 months

• Hip bone density

  12 months

Study Arms (4)

Testosterone + Vitamin D

ACTIVE COMPARATOR

Testosterone, transdermal gel, 75 mg, once per day, for 12 months AND Colecalciferol, oral drink solution, 24000 IU, once per month, for 12 months

Drug: Testosterone; Drug: Colecalciferol

Testosterone + Placebo

ACTIVE COMPARATOR

Testosterone, transdermal gel, 75 mg, once per day, for 12 months AND Placebo: Colecalciferol, oral drink solution, 0 IU, once per month, for 12 months

Drug: Testosterone; Drug: Placebo drink solution

Placebo + Vitamin D

ACTIVE COMPARATOR

Placebo: Testosterone, transdermal gel, 0 mg, once per day, for 12 months AND Colecalciferol, oral drink solution, 24000 IU, once per month, for 12 months

Drug: Colecalciferol; Drug: Placebo transdermal gel

Control

PLACEBO COMPARATOR

Placebo: Testosterone, transdermal gel, 0 mg, once per day, for 12 months AND Placebo: Colecalciferol, oral drink solution, 0 IU, once per month, for 12 months

Drug: Placebo drink solution; Drug: Placebo transdermal gel

Interventions

Testosterone DRUG

transdermal gel, 75 mg daily

Also known as: ATC code: G03BA03

Testosterone + Placebo; Testosterone + Vitamin D

Colecalciferol DRUG

drink solution, 24000 IU once per month

Also known as: Vitamin D3, CAS No: 67-97-0, ATC code: A11CC05

Placebo + Vitamin D; Testosterone + Vitamin D

Placebo drink solution DRUG

drink solution, 0 IU Colecalciferol once per month

Control; Testosterone + Placebo

Placebo transdermal gel DRUG

transdermal gel, 0 mg testosterone daily

Control; Placebo + Vitamin D

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
• Treatment with vitamin K-antagonists, insulin, adrenocorticotropic hormone (ACTH), corticosteroid (\>5mg/d)
• Elevated (≥ 4.0 ng/ml) prostate-specific antigen levels (at screening) and/or palpable signs of prostate cancer
• Palpable signs of breast-cancer
• Haemoglobin ≤ 100 g/l
• Haematocrit ≥ 0.50 L/L
• Liver function values (alanine aminotransferase, aspartate aminotransferase, Gamma-glutamyl transferase, alkaline phosphatase) more than 3 times the upper limit of normal.
• 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.
• Elevated serum calcium ≥ 2.60 mmol/l (adjusted for albumin )
• Estimated (Cockcroft and Gault formula ) creatinine clearance ≤ 30 ml/min
• Severe visual or hearing impairment
• History of cancer \< 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer
• Myocardial infarction in the last 3 months, unstable angina pectoris and/or exertional dyspnoea \>=NYHA III
• Treatment worthy but untreated sleep apnoea or chronic (obstructive) pulmonary disease, epilepsy
• 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

Sponsors & Collaborators

• University of Zurich: lead
• Swiss National Science Foundation: collaborator
• Besins Healthcare (funding: investigator-initiated and independent grant): collaborator
• Dr. Wild & Co. (funding: investigator-initiated and independent grant): collaborator
• Cantonal Hospital of St. Gallen: collaborator
• Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging: collaborator
• Centre on Ageing and Mobility (Dr. Andreas Egli): collaborator
• University Hospital, Zürich: collaborator

Study Sites (1)

Dept. of Geriatrics and Aging Research, University of Zurich / Geriatric Clinic University Hospital Zurich

Zurich, Canton of Zurich, 8037, Switzerland

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone; Cholecalciferol

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Cholestenes; Cholestanes; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Heike A Bischoff-Ferrari, MD, DrPH

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 17, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

CH (1)