Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172120
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2005-09-12
Brief Title:
Open Label Extension
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
An 18-month Open-label Extension Study of Once-daily ALX1-11 for the Treatment of Postmenopausal Women With Osteoporosis TRES
Status:
COMPLETED
Status Verified Date:
2021-05
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:
TRES
Brief Summary:
TRES will evaluate the effects of continued ALX1-11 treatment on the safety and efficacy variables assessed in the OLE study for a maximum treatment duration of 36 months in OLES and TRES combined
Detailed Description:
The primary goal of osteoporosis therapy is to prevent fracture and anabolic agents can accomplish this by strengthening bone structure which is accompanied by changes in BMD Effects of ALX1-11 on BMD have been previously documented in a dose-finding Phase II clinical trial in osteoporotic postmenopausal women taking calcium and vitamin D supplements who were otherwise naive to osteoporosis therapies The anabolic effects of ALX1-11 on lumbar vertebrae were statistically significant compared to placebo after 12 months of treatment In addition animal studies showed that the new bone formed by treatment with ALX1 11 is of good quality both histologically and biomechanically Mosekilde et al 1991 Kimmel et al 1993
Protocol ALX1-11-93001 TOP assessed the effect of 18 months of ALX1-11 treatment on fracture incidence as a primary efficacy variable and Protocol CL1-11-002 OLES assessed the effect on BMD for up to 24 months of treatment Subjects who will be enrolled in the current study TRES will be those who received placebo in TOP and ALX1-11 in OLES TRES will evaluate the effects of continued ALX1-11 treatment on the safety and efficacy variables assessed in the OLE study for a maximum treatment duration of 36 months in the OLES and TRES combined
Protocol ALX1-11-93001 TOP assessed the effect of 18 months of ALX1-11 treatment on fracture incidence as a primary efficacy variable and Protocol CL1-11-002 OLES assessed the effect on BMD for up to 24 months of treatment Subjects who will be enrolled in the current study TRES will be those who received placebo in TOP and ALX1-11 in OLES TRES will evaluate the effects of continued ALX1-11 treatment on the safety and efficacy variables assessed in the OLE study for a maximum treatment duration of 36 months in the OLES and TRES combined
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