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Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.

Last updated on February 22, 2019

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Study Location
Pfizer Investigational Site
Miami, Florida, 33126 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteopenia, Osteoporosis, Bone Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT01293487
Pfizer
Completed
Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.

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