Short summary

The use of opioids as long-term treatment for chronic pain has increased. Opioid treatment is associated with opioid induced endocrinopathy (OPIAD), defined by hypogonadotroph hypogonadism. Hypogonadism is known to be associated with sarcopenia, insulin resistance, increased body fat, loss of libido and sexual function and reduced quality of life. The indication for testosterone treatment of men with OPIAD is currently debated. In the present study we aim to examine the efficacy of 24 weeks testosterone replacement therapy in men with OPIAD on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life.

Rationale

The use of opioids as long-term treatment for chronic pain has increased. Opioid treatment is associated with opioid induced endocrinopathy (OPIAD), defined by hypogonadotroph hypogonadism. Hypogonadism is known to be associated with sarcopenia, insulin resistance, increased body fat, loss of libido and sexual function and reduced quality of life. The indication for testosterone treatment of men with OPIAD is currently debated.

Aim: To examine the efficacy of testosterone replacement therapy in men with OPIAD on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life.

Description of the cohort

Male patients aged 18-75 years treated with opioids for non-malignant diseases and diagnosed with hypogonadotroph hypogonadism. Participants are referred from day hospitals and outpatient populations. 40 patients are randomized to either testosterone undecanoate 1000 mg i.m. or placebo i.m., i.e. 20 patients per arm.

Data and biological material

Primary endpoint:

• Change in lean body mass from baseline (DXA-scan)

• Haemostatic status
• Pulse pressure
• 24 h blood pressure
• Lipid profile
• Waist
• Body fat (DXA-scan)
• Glucose tolerance (OGTT)
• HOMA- IR
• ACTH test
• Serum testosterone
• Bone mineral density (DXA-scan)
• Bone structure (HR-pQCT)
• Physical and muscle strength tests
• Pain threshold and tolerance tests
• Sexual function (questionnaires)
• Quality of life (questionnaires)

Collaborating researchers and departments

Deparment of Endocrinology, Odense University Hospital

• Primary investigator Marianne Skovsager Andersen
• Investigator Dorte Glintborg

Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

Department of Clinical Biochemistry, pharmacology and genetics, Odense University Hospital Department of Imaging, Odense University Hospital

Unit of Pain Research, Department of anesthesiology, Odense University Hospital

Unit for Thrombosis Research, Institute of Public Health, University of Southern Denmark