Clinical Trial: Clinical Comparison of Efficacy and Safety of Two Teriparatide Formulations: Osteofortil and Forteo
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Comparación de la Eficacia y Seguridad clínicas de Osteofortil Respecto de Forteo
Brief Summary: The primary objective of this study is to compare efficacy and safety of two formulations of teriparatide 20 mcg/day plus calcium and vitamin D in postmenopausal women with osteoporosis.
Detailed Summary:
Sponsor: Bio Sidus SA
Current Primary Outcome: Change from baseline in Bone mineral Density at 6 months. [ Time Frame: Basal, Six months and One Year ]
Original Primary Outcome: Change from baseline in Bone mineral Density at 6 months. [ Time Frame: Basal and Six months ]
Current Secondary Outcome: Change from baseline in P1NP, Osteocalcin, C-terminal cross-linked telopeptide of type I collagen levels at 3 and 6 months [ Time Frame: Basal, 3, 6 and 12 months ]
Original Secondary Outcome: Change from baseline in P1NP, Osteocalcin, C-terminal cross-linked telopeptide of type I collagen levels at 3 and 6 months [ Time Frame: Basal, 3 and 6 months ]
Information By: Bio Sidus SA
Dates:
Date Received: September 11, 2013
Date Started: June 2013
Date Completion: November 2014
Last Updated: January 21, 2014
Last Verified: September 2013
