Overview

This trial is active, not recruiting.

Condition postmenopausal osteoporosis with pathological fracture
Treatment teriparatide (rdna origin)
Phase phase 4
Sponsor Bio Sidus SA
Start date June 2013
End date October 2014
Trial size 110 participants
Trial identifier NCT01945788, 1301

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
20 micrograms/day plus calcium and vitamin D
teriparatide (rdna origin)
(Experimental)
20 micrograms/day plus calcium and vitamin D
teriparatide (rdna origin)

Primary Outcomes

Measure
Change from baseline in Bone mineral Density at 6 months.
time frame: Basal, Six months and One Year

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 50 years up to 81 years old.

Inclusion Criteria

    Exclusion Criteria

      Additional Information

      Official title Comparación de la Eficacia y Seguridad clínicas de Osteofortil Respecto de Forteo
      Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
      Information provided to ClinicalTrials.gov by Bio Sidus SA.