Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172133
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2005-09-12
Brief Title:
Open Label Extension Study of PREOS
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
An 18-Month Open Label Extension Study OLES of the Safety and Efficacy of Recombinant Human Parathyroid Hormone rhPTH1-84 ALX1-11 in Women With Postmenopausal Osteoporosis Who Participated in Protocol ALX1-11-93001 TOP Study
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OLES
Brief Summary:
This is an Open Label Extension Study OLES for patients who participated in the 18 month double-blind placebo-controlled Phase III trial Protocol ALX1 11 93001 the TOP Study studying the effect of ALX1-11 recombinant human parathyroid hormone rhPTH1-84 on vertebral fracture incidence The primary objective of this study is to evaluate the safety of continued dosing with ALX1-11 up to a maximum of 24 months in postmenopausal osteoporotic women who participated in Protocol ALX1 11 93001
Detailed Description:
Effects of ALX1-11 on bone mineral density BMD have been documented in a dose-finding Phase II clinical trial in osteoporotic postmenopausal women supplemented with calcium and Vitamin D3 but without any other treatment for osteoporosis The anabolic effects of ALX1-11 in the lumbar vertebrae were statistically significant after the 12-month treatment period and more pronounced than any approved therapy Additionally animal studies have shown that the new bone formed by treatment with ALX1 11 is of good quality both histologically and biomechanically
The primary objective of this OLES is to evaluate the safety of continued dosing with ALX1-11 up to a maximum of 24 months in postmenopausal osteoporotic women who participated in Protocol ALX1-11-93001 A secondary objective is to assess the change in vertebral BMD and compare the changes observed in patients who received ALX1-11 or placebo in Protocol ALX1-11-93001
Patients will receive 100 µgday of ALX1-11 daily via subcutaneous injection in this study Patients should continue the study drug dosing frequency they were following at the end of Protocol ALX1-11-93001
To enhance their safety all patients will continue to take their daily supplements of 700 mg calcium and 400 IU Vitamin D3 prior to and during this OLES Patients whose calcium supplement was discontinued during Protocol ALX1-11-93001 should maintain that discontinuation during this OLES However upon completion of ALX1-11 dosing in the OLES oral calcium supplement at a dose of 700 mg each morning should be restarted and maintained for the remainder of the OLES Additional supplemental calcium andor Vitamin D3 will not be permitted A daily multivitamin supplement may be taken during the study However the multivitamin must contain no more than 200 mgday calcium and 400 IUday Vitamin D3 Patients will be monitored for the development of hypercalcemia andor hypercalciuria and managed as described in Appendices 4 and 5
There will be a stopping rule in this OLES Any patient who reaches a BMD T score of -05 or above at the site or sites vertebral total hip or femoral neck that were used in the qualification of the patient for Protocol ALX1 11-93001 will stop ALX1-11 treatment The patient must continue on calcium and Vitamin D3 and be followed for the remainder of this 18-month OLES At the time of discontinuation the patient must complete the Month 18 evaluations Appendix 1A or 1B
The Clinical Advisory Board CAB used in Protocol ALX1-11-93001 will be involved in reviewing any patient issues that arise in this OLES This group will provide not only continuity of care for all the patients but also enhanced and consistent safety monitoring for patients participating in the OLES
The primary objective of this OLES is to evaluate the safety of continued dosing with ALX1-11 up to a maximum of 24 months in postmenopausal osteoporotic women who participated in Protocol ALX1-11-93001 A secondary objective is to assess the change in vertebral BMD and compare the changes observed in patients who received ALX1-11 or placebo in Protocol ALX1-11-93001
Patients will receive 100 µgday of ALX1-11 daily via subcutaneous injection in this study Patients should continue the study drug dosing frequency they were following at the end of Protocol ALX1-11-93001
To enhance their safety all patients will continue to take their daily supplements of 700 mg calcium and 400 IU Vitamin D3 prior to and during this OLES Patients whose calcium supplement was discontinued during Protocol ALX1-11-93001 should maintain that discontinuation during this OLES However upon completion of ALX1-11 dosing in the OLES oral calcium supplement at a dose of 700 mg each morning should be restarted and maintained for the remainder of the OLES Additional supplemental calcium andor Vitamin D3 will not be permitted A daily multivitamin supplement may be taken during the study However the multivitamin must contain no more than 200 mgday calcium and 400 IUday Vitamin D3 Patients will be monitored for the development of hypercalcemia andor hypercalciuria and managed as described in Appendices 4 and 5
There will be a stopping rule in this OLES Any patient who reaches a BMD T score of -05 or above at the site or sites vertebral total hip or femoral neck that were used in the qualification of the patient for Protocol ALX1 11-93001 will stop ALX1-11 treatment The patient must continue on calcium and Vitamin D3 and be followed for the remainder of this 18-month OLES At the time of discontinuation the patient must complete the Month 18 evaluations Appendix 1A or 1B
The Clinical Advisory Board CAB used in Protocol ALX1-11-93001 will be involved in reviewing any patient issues that arise in this OLES This group will provide not only continuity of care for all the patients but also enhanced and consistent safety monitoring for patients participating in the OLES
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