NCT00365924

Brief Summary

This methodology trial will be conducted in patients with osteoporosis and will measure the changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone density following therapy with the approved drug, Forteo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 23, 2009

Status Verified

June 1, 2008

First QC Date

August 16, 2006

Last Update Submit

March 20, 2009

Conditions

Osteoporosis

Keywords

12 month therapy with postmenopausal women with osteoporosis to examine changes in bone quality parameters

Outcome Measures

Primary Outcomes (1)

  • Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo

    12 months

Secondary Outcomes (1)

  • Changes in BMD and bone biomarkers following 12 months of therapy with Forteo

    12 months

Study Arms (1)

Forteo

OTHER
Drug: Forteo

Interventions

ForteoDRUG

Open label single arm study with Forteo as an intervention

Also known as: Recombinant Human PTH 1-34
Forteo

Eligibility Criteria

Age55 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women with osteoporosis

You may not qualify if:

  • Any therapies or products affecting bone turnover within 12 months of Screening.
  • Bisphosphonate treatment \>1 month in total duration at any time in the past.
  • In addition, patients must be bisphosphonate-treatment-free for at least 12 months prior to Screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Buenos Aires, C1055AAK, Argentina

Location

Pfizer Investigational Site

Buenos Aires, C1428AQK, Argentina

Location

Pfizer Investigational Site

Capital Federal - Buenos Aires, C1012AAP, Argentina

Location

Related Links

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 18, 2006

Study Start

December 1, 2006

Study Completion

April 1, 2008

Last Updated

March 23, 2009

Record last verified: 2008-06

Locations

AR(3)