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. 2017 Jul 13;40(6):733–747. doi: 10.1080/10790268.2017.1350341

Table 2.

Primary and secondary outcomes of interest related to endocrine-metabolic disease risk (EMD).

Outcomes of interest
Primary outcomes

  1. Incident fragility fractures of the hip, vertebra or other sites confirmed by X-ray;

  2. Incident diabetes mellitus was defined as self-report of physician-diagnosed diabetes, recent diabetes medication use, a blood glucose level of ≥126 mg/dL fasting, or a blood glucose level of ≥200 mg/dL non-fasting;

  3. Incident HF defined as the first occurrence of either (1) a hospitalization that included an International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) discharge diagnosis code for HF beginning with “428″ or (2) a death certificate ICD-9 code beginning with “428” HF or ICD-10 code “I50” in any position56,57;

  4. Incident MI or coronary heart disease defined as self-report of physician-diagnosed MI or silent MI identified by electrocardiography, coronary revascularization, or coronary artery bypass surgery;

  5. Incident hypertension was defined by either a DBP ≥90 mmHg or a SBP ≥140 mmHg measured with random-zero mercury manometers, or recent antihypertensive medication use;

  6. Adverse events related and unrelated to the intervention

Secondary outcomes

  1. BMD of lumbar spine, hip, or knee via DXA;

  2. Bone turnover markers using urinary/blood analysis;

  3. Body composition/adiposity of whole body, trunk, and limbs using DXA, bioelectrical impedance analysis, or magnetic resonance imaging;

  4. Bone microarchitecture and bone geometry of the radius or tibia using pQCT;

  5. Skeletal muscle and fat CSA, mass, or density of the legs using pQCT;

  6. Muscle fiber type composition via muscle biopsy;

  7. Lipid and carbohydrate metabolism biomarkers using blood sample analysis, including, but not limited to, triglycerides, cholesterol, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol, fasting insulin and glucose, and homeostatic model assessment;

  8. DBP and SBP measured at rest with random-zero mercury manometers;

  9. Anthropometric measures of body weight, body mass index, or site circumference/girth (e.g., waist, thigh);

  10. Inflammatory, antioxidant, and other endocrine biomarkers using blood analysis.

Note: HF = Heart failure; MI = Myocardial infarction; BMD = Bone mineral density; DXA = Dual energy X-ray absorptiometry; pQCT = Peripheral quantitative computed tomography; DBP = Diastolic blood pressure; SBP = Systolic blood pressure.