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

Pfizer

Status: Completed

Conditions: Osteoporosis

Treatments: Drug: Forteo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00365924

A9001294

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 55 to 70 years old

Volunteers: No 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.

Trial design

20 participants in 1 patient group

Forteo

Other group

Treatment:

Drug: Forteo