Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00092053
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2004-09-21
Brief Title:
Study of Investigational Drug in Osteoporosis MK-0217-908
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Persistence of the Effect of Oral Monthly Ibandronate on Bone Reception in Postmenopausal Women in Osteoporosis
Status:
COMPLETED
Status Verified Date:
2022-02
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:
The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis The primary hypothesis of this study is that in postmenopausal women with osteoporosis oral monthly ibandronate at doses of 100 mg and 150 mg does not achieve persistence in reduction of bone resorption throughout the monthly dosing interval as demonstrated by a larger change in the serum carboxyterminal crosslinked telopeptide of Type I collagen CTX-I log-transformed fraction from baseline four weeks post dose compared to one week post dose during the third month of treatment in the participants taking ibandronate than in the participants taking placebo
Detailed Description:
None
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