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

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NCT01293487

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Miami, Florida, 33126 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

- 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.
Show details

- 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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Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.
A Phase I Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of RN564 In Women With Osteopenia And In Healthy Men
The purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteopenia
  • Osteoporosis
  • Bone Disease
Biological: RN564
Intravenous, single dose with experimental dose
Experimental: Arm 1
Intervention: Biological: RN564
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
May 2012
May 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
55 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01293487
B1151001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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