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
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)
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
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
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
History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism,
hypoor hyperparathyroidism or malabsorptive syndromes within the past year.
40 Years to 85 Years
Accepts Healthy Volunteers