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

Last updated on November 15, 2019

FOR MORE INFORMATION
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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Descriptive Information
Brief Title  ICMJE Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.
Official Title  ICMJE 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
Brief SummaryThe purpose of this study is to determine the safety and tolerability of RN564 in women with osteopenia and healthy men.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteopenia
  • Osteoporosis
  • Bone Disease
Intervention  ICMJE Biological: RN564
Intravenous, single dose with experimental dose
Study Arms  ICMJE Experimental: Arm 1
Intervention: Biological: RN564
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2011)
68
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion DateMay 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01293487
Other Study ID Numbers  ICMJE B1151001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2012

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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