Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130403
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2005-08-12
Brief Title:
OPTAMISE Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Open-Label Study to Determine How Prior Therapy With Alendronate or Risedronate in Postmenopausal Women With Osteoporosis Influences the Clinical Effectiveness of Teriparatide
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide The primary objective of the study is to compare the teriparatide human recombinant PTH1-34-associated change from baseline in a marker of bone formation N-terminal propeptide of type I collagen P1NP between subjects previously treated with risedronate and those previously treated with alendronate
Detailed Description:
All subjects will be treated with teriparatide human recombinant PTH1-34human recombinant PTH1-34 20 microgram subcutaneously daily for 12 months Subjects will consist of 290 postmenopausal women previously treated with either risedronate or alendronate for at least 24 months An approximately equal number of subjects will have been previously treated with risedronate and alendronate and the subjects will be balanced with regard to duration of previous treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2004-002317-37 | None | None | None |