Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112437
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2005-06-02
Brief Title:
A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis MK-0822-004
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Assess the Safety Tolerability and Efficacy of MK-0822 Cathepsin K Inhibitor in the Treatment of Postmenopausal Women With Osteoporosis
Status:
COMPLETED
Status Verified Date:
2017-12
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:
This is a 1-year base study with a 1-year extension to examine the effects of a new experimental medication odanacatib MK-0822 on postmenopausal osteoporosis This study will enroll approximately 375 postmenopausal women and randomly assign them to 4 different doses of odanacatib or to placebo Measurements performed during the study include bone mineral density scans spine x-rays laboratory blood and urine tests height measurements and optional bone biopsies at the end of 2 years
Detailed Description:
Study Extension
Participants who completed 12 months of the base study and 12 months of the first extension were invited to continue in three additional extensions MK0-822-004-10 which extended the study to 36 months MK-0822-004-20 NCT00112437 which extended the study to 60 months and MK-0822-004-30 NCT00112437 which extended the study to 120 months
In the first extension participants continued to receive the same treatment they received in the 12-month base study
In the second extension participants were re-randomized to odanacatib 50 mg OW or placebo OW for 12 months
In the third extension participants who were initially randomized to odanacatib 3 mg or placebo OW in the base study received odanacatib 50 mg weekly in Years 4 and 5 all other participants remained on the same treatment they were during Year 3
In the fourth extension all participants received odanacatib weekly in Years 6-10
Study arms for extensions include only odanacatib 50 mg and placebo for the first two extensions and odanacatib 50 mg only for the third extension
Extension Studies
MK-0822-004-10 NCT00112437 Extension Participant has participated in and completed 24 months of treatment in the base study
MK-0822-004-20 NCT00112437 Extension Participant participated in and completed 36 months of treatment in base and extension studies
MK-0822-004-30 NCT00112437 Extension Participant participated in and completed 60 months of treatment in the base and extension studies
Participants who completed 12 months of the base study and 12 months of the first extension were invited to continue in three additional extensions MK0-822-004-10 which extended the study to 36 months MK-0822-004-20 NCT00112437 which extended the study to 60 months and MK-0822-004-30 NCT00112437 which extended the study to 120 months
In the first extension participants continued to receive the same treatment they received in the 12-month base study
In the second extension participants were re-randomized to odanacatib 50 mg OW or placebo OW for 12 months
In the third extension participants who were initially randomized to odanacatib 3 mg or placebo OW in the base study received odanacatib 50 mg weekly in Years 4 and 5 all other participants remained on the same treatment they were during Year 3
In the fourth extension all participants received odanacatib weekly in Years 6-10
Study arms for extensions include only odanacatib 50 mg and placebo for the first two extensions and odanacatib 50 mg only for the third extension
Extension Studies
MK-0822-004-10 NCT00112437 Extension Participant has participated in and completed 24 months of treatment in the base study
MK-0822-004-20 NCT00112437 Extension Participant participated in and completed 36 months of treatment in base and extension studies
MK-0822-004-30 NCT00112437 Extension Participant participated in and completed 60 months of treatment in the base and extension studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2005_023 | None | None | None |