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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00365924

Enrollment

Registered

2006-08-18

Start date

2006-12-31

Completion date

2008-04-30

Last updated

2009-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

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

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.

Interventions

DRUGForteo

Open label single arm study with Forteo as an intervention

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

55 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026