Effect of HMB and vitamin D supplementation on osteosarcopenia in older persons

Exclusion Criteria16

• History of a lower limb fracture (e.g., femur, tibia) within the past 6 months with persistent negative impact on lower extremity function or any significant impairment or disease adversely impacting gait (e.g., intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip);
• Neurological injury/disorder with significant persistent neurological or functional deficit (e.g., stroke with hemiparesis, spinal cord injury, muscular dystrophy, myopathy, myasthenia gravis, Parkinson’s disease, peripheral polyneuropathy);
• Medical conditions associated with muscle loss;
• Chronic kidney disease [estimated glomerular filtration rate (GFR) < 30 mL/min];
• History of confirmed chronic obstructive pulmonary disease with a severity grade > 2 on the Medical Research Council Dyspnea Scale;
• Uncontrolled hypothyroidism or hyperthyroidism. Hypothyroid patients who have changed their dose of hormone replacement therapy in the 6 weeks prior to screening are not eligible for the study;
• Underlying muscle diseases, including history of or currently active myopathy (e.g., dermatomyositis, polymyositis, etc.) or muscular dystrophies;
• Confirmed rheumatoid arthritis, acquired immunodeficiency syndrome (AIDS), or type 1 diabetes mellitus;
• History of or ongoing gastrointestinal diseases known to cause malabsorption of protein or energy, such as inflammatory bowel disease, celiac disease, short bowel syndrome, pancreatic insufficiency;
• Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis) or conditions with hepatotoxic potential (e.g., known gallbladder or bile duct disease, acute or chronic pancreatitis);
• Active cancer (i.e., under current treatment), or cancer requiring treatment in the last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis (e.g., early stage prostate or breast cancer, or carcinoma in situ of the uterine cervix);
• Uncontrolled type 2 diabetes mellitus (i.e., HbA1C greater than or equal to 8.0% or frequent hypoglycemia);
• Any chronic active infection (e.g., HIV, hepatitis B or C, tuberculosis, etc.).
• Active alcohol/drug abuse, or alcohol/drug treatment < 12 months prior to screening; subjects having successfully completed an alcohol/drug treatment program >12 months prior to screening with sustained abstinence are eligible;
• Use of any therapies known to affect muscle mass, including androgens, androgen supplements [including over-the-counter dehydroepiandrosterone (DHEA)], gonadotropin releasing hormone (GnRH) analogues, anti-androgens, anti-estrogens (e.g., tamoxifen), progestins with known androgenic component (e.g., norethindrone acetate), megestrol acetate, high-dose tibolone (2.5 mg), recombinant human growth hormone, growth hormone receptor antagonists (e.g., pregvisomant), oral selective beta-2 agonists, or dronabinol within 3 months prior to randomisation; and any nutritional supplement marketed as a muscle anabolic.
• Ongoing corticosteroid use, or history of systemic corticosteroid use for at least 3 months (in the last year) prior to screening at a daily dose greater than or equal to 10 milligram (mg) prednisone equivalent.