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The purpose of this study is to increase the functional level of the elderly to thereby reduce fall risk, improve motor skills, and increase psychological well-being, as well as to assess whether the restoration of a normal testosterone level contributes to a faster recovery. The effect of testosterone is investigated as measured by physical and mental functional capacity, including cognition, in hypogonadal elderly men with a significant loss of function. The study is aimed at participants who are too weak to participate in the progressive strength training.
Please see the uploaded study protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | No Intervention | Patients receiving placebo | |
| Intervention | Active Comparator | Patients receiving testosterone undecanoate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebido (Testosterone Undecanoate) | Drug | Testosterone supplementation is given intramuscularly with 1000 mg testosterone undecanoate, which has an effect for approx. 12 weeks, but which can be repeated more frequently between the 1st and 2nd administration. The injection is thus repeated in week 6. 3 injections per trial subject are expected, i.e., in weeks 1, 6, and 16. If the participants are motivated to continue so that long-term effects can be measured, the participants will be asked in week 12 whether they wish to continue to week 52. Upon acceptance of continuation to week 52, testosterone and placebo injections are offered according to original groups in weeks 26, 36, and 46, after which testing of primary and secondary endpoints is not only performed in week 20 but also in week 52. |
| Measure | Description | Time Frame |
|---|---|---|
| Chair-stand test | A measure of general strength in extremities. Number of times the participant can stand up and sit down from a chair in 30 seconds. A good correlation (r=0.78) has been found with leg press and acceptable test-retest reliability (ICC=0.86). It has recently been scientifically documented that the ability among elderly persons to perform this simple test correlates with the risk of serious fall accidents | At weeks 0, 4 and 20. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of fall frequency and severity | Registered via a questionnaire for each trial subject and is also included in the monitoring of adverse events. | At weeks 0, 4 and 20. |
| Balance ability |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria: Men aged 70 or over.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rune S. Rasmussen, MSc, PhD | Contact | +4528757500 | rsr@sund.ku.dk | |
| Karsten Overgaard, MD, Neurologist | Contact | 26172611 | Karsten.Overgaard@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Mette Midttun, MD, DMSc | Holbaek Sygehus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holbæk Hospital | Holbæk | 4300 | Denmark |
If there is interest, we will consider sharing data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 23, 2026 | Apr 23, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C010792 | testosterone undecanoate |
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Participants are randomized equally into 2 different treatment groups with 48 participants each:
Randomization is thus into two arms so that the effect of testosterone can be evaluated against placebo.
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Treatment with testosterone is made double-blind. We will ensure that the persons evaluating a patient do not have knowledge of the patient's treatment group.
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Tested via the Tandem test, which contains three starting positions: 1) Standing with feet together, standing in semi-tandem stance, and standing in tandem stance.
| At weeks 0, 4 and 20. |
| Avlund's mobility scale | Questions about experiencing fatigue and need for support in common activities of daily living. Avlund's mobility scale is correlated with isometric muscle strength, simple functional tests, increased risk of hospitalizations, and mortality. Good inter- and intra-reliability (kappa 0.72-1.00) has been shown. Scores range from 0 to 6, and higher scores indicate worse outcome. | At weeks 0, 4 and 20. |
| Geriatric Depression Scale (GDS) | Questionnaire about depression and psychological well-being. Scores range from 0 til 15. Score below 5 are normal, while scores of 5 or higher indicate varying degrees of depression, scoring 13-15 indicates severe depression. | At weeks 0, 4 and 20. |
| Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment is a cognitive screening instrument which provides an estimate of the level of intellectual functioning. Scores are from 0 to 30, where a score of 26 or higher is considered normal. Montreal Cognitive Assessment is moreover sensitive to mild cognitive problems as well as dementia. Studies have shown that Montreal Cognitive Assessment is more sensitive than Mini Mental State Examination to detecting mild cognitive changes and is as effective in identifying the incidence of Alzheimer's disease. | At weeks 0, 4 and 20. |
| Mini Mental State Examination (MMSE) | Cognitive screening test that provides an estimate of the intellectual functional level. This test is included as it is performed as standard at the Geriatric Outpatient Clinic. Combined, MMSE and MoCA provide a broader assessment of cognitive functional level. Scores range from 0 to 30, higher scores indicate better cognitive status. Scores from 26 to 30 are considered normal. | At weeks 0, 4 and 20. |
| Quality of life EQ-5D | Questionnaire about perceived quality of life. Scores range from 0 to 1 (first scale) and from 0 to 100 (second scale). Higher scores indicate better quality of life. | At weeks 0, 4 and 20. |
| Clinical Frailty Scale (CFS) | General assessment of health and functional level in the elderly. Scoring ranges from 1 to 9, and higher scores indicate more frailty. | At weeks 0, 4 and 20. |
| Falls Efficacy Scale - International (FES-I, Fear of falling). Scores range from 16 to 64, and higher scores indicate increased anxiety of having a severe fall accident. | Assessment of fall risk in the elderly. | At weeks 0, 4 and 20. |