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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-01

Study Completion Date

2012-05-24

Brief Summary

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

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Detailed Description

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Conditions

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Osteopenia Osteoporosis Bone Disease

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

RN564

Intervention Type BIOLOGICAL

Intravenous, single dose with experimental dose

Interventions

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RN564

Intravenous, single dose with experimental dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes