Phase 3 N=407 Randomized Treatment

Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)

Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT00365456 ↗

Enrolled (actual)

407

Serious AEs

9.5%

Results posted

Jul 2012

Primary outcome: Primary: Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III. — 1.002; 0.990 Percentage Change — p=0.010

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Parathyroid Hormone (PTH) (Drug); Risedronate (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: Female
Sponsor: Takeda
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.	1.002; 0.990	0.010 sig

Summary

The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.

Eligibility Criteria

Inclusion Criteria

Women above the age of 50 years with the diagnosis of postmenopausal primary osteoporosis may be enrolled in the trial if the following inclusion/exclusion criteria apply.

All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.

Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject).
Is the subject above 50 years old?
Is the subject postmenopausal (more than 5 years) - in the judgement of the investigator?
Does the subject have primary osteoporosis with a lumbar spine T score 3 years?
Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)?

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00365456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.