Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
- Registration Number
- NCT00365456
- Lead Sponsor
- Takeda
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 407
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 < -3.0 SD (at lumbar spine L1-L4, with a minimum of two evaluable vertebrae)?
- Does the subject have a life expectancy of >3 years?
- Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)?
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PTH (1-84) Parathyroid Hormone (PTH) - Risedronate Risedronate -
- Primary Outcome Measures
Name Time Method Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III. 12 months BMD was measured by Dual X-ray Absorptiometry (DXA).
- Secondary Outcome Measures
Name Time Method