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

Pfizer20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Osteoporosis

Interventions

ForteoDRUG

Open label single arm study with Forteo as an intervention

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (3)

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Capital Federal - Buenos Aires, Argentina

Outcomes

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

Data from ClinicalTrials.gov

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