- Diagnosis of osteopenia for women (BMD T-scores between -1.0 and - 2.5 SD at the
lumbar spine, the femoral neck or total hip)
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- Have at least 3 vertebral bodies in the L1-L4 region and one femoral neck site that
are accessible by DXA.
- Evidence or history of any underlying condition, other than primary osteopenia, that
affect bone metabolism (eg, hyperparathyroidism, hypoparathyroidism).
- Subjects with pre-existing periodontal/dental disease or those who have undergone
invasive dental procedures (eg, tooth extraction, oral surgery) within 60 days prior
to Day -1.
- If QTcF exceeds 455 msec, the ECG should be repeated two more times and the average of
the three QTcF values should be used to determine the subject's eligibility.