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

Completed · Phase 1

Conditions studied: Osteopenia, Osteoporosis, Bone Disease

In brief

The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.

Key facts

Study ID

NCT01293487

Run by

Pfizer

People needed

68

Starts

2011-04-01

Expected to finish

2012-05-24

Last updated by the study team

2024-09-24

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ambulatory Diagnostic Center — Coral Gables, Florida, United States
• Gable Diagnostics — Coral Gables, Florida, United States
• Gables Diagnostics — Coral Gables, Florida, United States
• SeaView Research, Inc. — Miami, Florida, United States
• SeaView Research, Inc. — Miami, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• MRA Clinical Research — South Miami, Florida, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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