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
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 April 16, 2014