Phase 3
Completed N=407
Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
Source: ClinicalTrials.gov NCT00365456 ↗Enrolled (actual)
407
Serious AEs
9.5%
Results posted
Jul 2012
Primary outcomePrimary: 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
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.
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 |
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)?
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. Informational only — not medical advice.