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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pfizer Investigational Site, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Forteo

Drug

Open label single arm study with Forteo as an intervention

Other names: Recombinant Human PTH 1-34

Primary outcomes

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

Time frame: 12 months

Secondary outcomes

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

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Recombinant Human Parathyroid Hormone, PTH (Forteo)

Important dates

Study start: 2006
Study completion: 2008
First posted: Aug 18, 2006
Registry last updated: Mar 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed