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

The primary objective of this prospective controlled study is to evaluate the efficacy and
the safety of abaloparatide-SC 80 mcg per day compared to placebo as assessed by change in
bone mineral density over 12 months.

INCLUSION CRITERIA

- Healthy ambulatory male from 40 to 85 years of age (inclusive) with primary
osteoporosis or osteoporosis associated with hypogonadism.

- The patient has a BMD T-score (based on the female reference range as assessed by the
central imaging vendor) of ≤ -2.5 at the lumbar spine (L1-L4) or hip (femoral neck or
total hip) by DXA or ≤-1.5 and with radiologic evidence of vertebral fracture or a
documented history of low-trauma nonvertebral fracture sustained in the past 5 years.
Men older than 65 years may be enrolled if they have a BMD T-score ≤ -2.0 even if they
do not meet the fracture criteria.

- Normal medical history, physical examination, including vital signs, and body mass
index (BMI).

- Hypogonadal patients whose doses of androgens have been stable for at least twelve
months before randomization are eligible and may continue therapy during the study.

- Laboratory tests within the normal range including serum calcium (albumin-corrected),
PTH, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone (TSH)
values.

EXCLUSION CRITERIA

- Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal
bone mineral density, 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 upon the
female reference range.

- Unevaluable hip BMD or patients 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 (e.g., Paget's disease) other than osteoporosis.

- Patients 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
patient.

- History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism,
hypo- or hyperparathyroidism or malabsorptive syndromes within the past year.