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

Study Overview
=================
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.

Official Title
-----------------
An Open Label, International, Multi Centre, Parallel Group, Phase III b, Randomised Trial, Investigating Lumbar Spine Bone Mineral Density (BMD) Changes in Postmenopausal Women With Primary Osteoporosis Initially Treated With 12 Months of Full Length Parathyroid Hormone (PTH 1-84) Followed by 12 Months of Treatment With Risedronate Followed by Either 12 Months Treatment With PTH (1-84) or Risedronate.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Parathyroid Hormone (PTH)
* Drug: Risedronate


Participation Criteria
=================
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 < -3.0 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)?

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTH (1-84)<br> | Drug: Parathyroid Hormone (PTH)<br>* Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen.<br>|
| Active Comparator: Risedronate<br> | Drug: Risedronate<br>* Orally once weekly as one 35 mg tablet.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III. | BMD was measured by Dual X-ray Absorptiometry (DXA). | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lumbar Spine Bone Mineral Density (BMD)