Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)

Exclusion Criteria

• •Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal BMD, defined as having at least 2 radiologically evaluable vertebrae within L1-L4.
• •A BMD T-score of ≤-3.5 at the total hip, femoral neck, or lumbar spine based on female or male reference range (depending on date of enrollment).
• •Unevaluable hip BMD or participants who have undergone bilateral hip replacement.
• •Fragility fracture within the prior twelve months.
• •History of severe vertebral fracture or \>2 moderate vertebral fractures.
• •History of bone disorders (for example, Paget's disease) other than osteoporosis.
• •participant with clinical signs of hypogonadism present at screening who plan to initiate testosterone replacement.
• •History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine.
• •History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the participant.
• •History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year.