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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02419105
Recruitment Status : Terminated (Delayed recruitment mainly due to a screening to inclusion rate much lower than expected. Due to the delayed recruitment IMP reached the end of its shelf life.)
First Posted : April 17, 2015
Last Update Posted : June 18, 2020
Sponsor:
Collaborators:
Swiss National Science Foundation
Besins Healthcare (funding: investigator-initiated and independent grant)
Dr. Wild & Co. (funding: investigator-initiated and independent grant)
Cantonal Hospital of St. Gallen (PD Dr. Thomas Müntzer)
Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging
Centre on Ageing and Mobility (Dr. Andreas Egli)
University Hospital of Zurich, Dept. of Geriatrics (Prof. Robert Theiler, Dr. Gregor Freystaetter)
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Hypogonadism Pre-frail Seniors Drug: Testosterone Drug: Colecalciferol Drug: Placebo drink solution Drug: Placebo transdermal gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2015
Actual Primary Completion Date : May 2020
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls Vitamin D

Arm Intervention/treatment
Active Comparator: Testosterone + Vitamin D
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
transdermal gel, 75 mg daily
Other Name: ATC code: G03BA03

Drug: Colecalciferol
drink solution, 24000 IU once per month
Other Name: Vitamin D3, CAS No: 67-97-0, ATC code: A11CC05

Active Comparator: Testosterone + Placebo
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
transdermal gel, 75 mg daily
Other Name: ATC code: G03BA03

Drug: Placebo drink solution
drink solution, 0 IU Colecalciferol once per month

Active Comparator: Placebo + Vitamin D
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
drink solution, 24000 IU once per month
Other Name: Vitamin D3, CAS No: 67-97-0, ATC code: A11CC05

Drug: Placebo transdermal gel
transdermal gel, 0 mg testosterone daily

Placebo Comparator: Control
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
drink solution, 0 IU Colecalciferol once per month

Drug: Placebo transdermal gel
transdermal gel, 0 mg testosterone daily




Primary Outcome Measures :
  1. Number of fallers [ Time Frame: 12 months ]
    The participant will fill in a falls diary.

  2. Rate of falls [ Time Frame: 12 months ]
    The participant will fill in a falls diary.


Secondary Outcome Measures :
  1. Appendicular lean skeletal muscle mass (aLSM) [ Time Frame: 12 months ]
    measured by dual energy X-ray absorptiometry (aLSM is defined as of skeletal muscles in upper and lower extremities)

  2. Lower extremity function [ Time Frame: 12 months ]
    assessed with the Short Physical Performance Battery (SPPB)

  3. Reaction time [ Time Frame: 12 months ]
    assessed by repeated sit-to-stand test (part of the SPPB)

  4. Gait Speed [ Time Frame: 12 months ]
    assessed by 4 meter walk test (part of the SPPB)

  5. Quality of life [ Time Frame: 12 months ]
    assessed by EuroQol (EQ5D-3L)


Other Outcome Measures:
  1. Cognitive function [ Time Frame: 12 months ]
    assessed by the Montreal Cognitive Assessment (MoCA) test

  2. Body composition [ Time Frame: 12 months ]
    measured by dual energy X-ray absorptiometry

  3. Hip bone density [ Time Frame: 12 months ]
    measured by dual energy X-ray absorptiometry

  4. Incidence of sarcopenia [ Time Frame: 12 months ]
    Since there is no consensus on a universally accepted definition of sarcopenia to date, all previously used and newly proposed composite definitions of sarcopenia based on lean mass and the SPPB, its components and/or grip strength, will be considered.

  5. Bone quality (bone micro-architecture and bone strength) [ Time Frame: 12 months ]
    measured by high-resolution peripheral quantitative computed tomography (XtremeCT)

  6. serum concentrations of 25(OH)D [ Time Frame: 12 months ]
    Adherence, Laboratory measures at the Institute of Clinical Chemistry at the University Hospital Zürich

  7. free and bioavailable testosterone (serum concentration of total testosterone, sex hormone binding globulin, albumin) [ Time Frame: 12 months ]
    Adherence, Laboratory measures at the Institute of Clinical Chemistry at the University Hospital Zürich, total testosterone will be measured, free and bioavailable testosterone will be calculated

  8. haemoglobin, haematocrit, prostate-specific antigen, calcium, creatinine, alanine aminotransferase, aspartate aminotransferase, Gamma-glutamyl transferase, alkaline phosphatase [ Time Frame: 12 months ]
    Laboratory measures at the laboratory of the City Hospital Waid, Zürich

  9. Incidence of cardiovascular adverse events [ Time Frame: 12 months ]
    "cardiovascular event" defined as: myocardial infarction, stroke, revascularization procedure of coronary artery bypass graft and percutaneous coronary intervention, incident congestive heart disease (heart insufficiency), cardiovascular mortality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419105


Locations
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Switzerland
Dept. of Geriatrics and Aging Research, University of Zurich / Geriatric Clinic University Hospital Zurich
Zürich, ZH, Switzerland, 8037
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
Besins Healthcare (funding: investigator-initiated and independent grant)
Dr. Wild & Co. (funding: investigator-initiated and independent grant)
Cantonal Hospital of St. Gallen (PD Dr. Thomas Müntzer)
Tufts University Jean Mayer USDA Human Nutrition Research Center on Aging
Centre on Ageing and Mobility (Dr. Andreas Egli)
University Hospital of Zurich, Dept. of Geriatrics (Prof. Robert Theiler, Dr. Gregor Freystaetter)
Investigators
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Principal Investigator: Heike A Bischoff-Ferrari, MD, DrPH University of Zurich
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02419105    
Other Study ID Numbers: T&D Study
32003B_135192 ( Other Grant/Funding Number: Swiss National Science Foundation )
SNCTP: 000001224 ( Registry Identifier: Swiss Clinical Trials Portal )
KEK-ZH-2014-0436 ( Other Identifier: Cantonal Ethics Committee Zurich, Switzerland )
2105DR3024 ( Other Identifier: Swiss Agency for Therapeutic Products (Swissmedic) )
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Keywords provided by University of Zurich:
Falls
hypogonadal men
Seniors
Testosterone
Colecalciferol
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Vitamin D
Cholecalciferol
Testosterone
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists