A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Forteo

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00365924
First received: August 16, 2006
Last updated: March 20, 2009
Last verified: June 2008
  Purpose

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.


Condition Intervention
Osteoporosis
Drug: Forteo

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Recombinant Human Parathyroid Hormone, PTH (Forteo)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in BMD and bone biomarkers following 12 months of therapy with Forteo [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2006
Study Completion Date: April 2008
Arms Assigned Interventions
Forteo Drug: Forteo
Open label single arm study with Forteo as an intervention
Other Name: Recombinant Human PTH 1-34

  Eligibility

Ages Eligible for Study:   55 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women with osteoporosis

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365924

Locations
Argentina
Pfizer Investigational Site
Buenos Aires, Argentina, C1055AAK
Pfizer Investigational Site
Buenos Aires, Argentina, C1428AQK
Pfizer Investigational Site
Capital Federal - Buenos Aires, Argentina, C1012AAP
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00365924     History of Changes
Other Study ID Numbers: A9001294
Study First Received: August 16, 2006
Last Updated: March 20, 2009
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Pfizer:
12 month therapy with postmenopausal women with osteoporosis to examine changes in bone quality parameters

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014