Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM) (PEAK)
|ClinicalTrials.gov Identifier: NCT00365456|
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : July 20, 2012
Last Update Posted : August 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Drug: Parathyroid Hormone (PTH) Drug: Risedronate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||407 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||August 2011|
|Experimental: PTH (1-84)||
Drug: Parathyroid Hormone (PTH)
Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen.
|Active Comparator: Risedronate||
Orally once weekly as one 35 mg tablet.
- Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III. [ Time Frame: 12 months ]BMD was measured by Dual X-ray Absorptiometry (DXA).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365456
|Study Chair:||Nycomed Clinical Trial Operations||Headquaters|