Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172172
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2005-09-13
Brief Title:
Calcium Supplementation in Postmenopausal Women
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
A Study to Evaluate the Effects of Calcium Supplementation on the Efficacy and Safety of Recombinant Human Parathyroid Hormone ALX1-11 in Postmenopausal Women With Osteoporosis CAP 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:
CAP
Brief Summary:
This study is evaluating the effects of calcium supplementation on the efficacy and safety of recombinant parathyroid hormone ALX1-11 in postmenopausal women with osteoporosis The primary objective of this clinical study is to evaluate whether increases in bone mineral density BMD for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases in BMD observed for subjects treated with ALX1-11 and receiving calcium supplementation
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 clinical study is to evaluate whether increases in bone mineral density BMD for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases in BMD observed for subjects treated with ALX1-11 and receiving calcium supplementation
A secondary objective of this clinical study are to evaluate whether changes in other efficacy parameters such as bone mineral content BMC and biochemical markers of bone turnover for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases observed for subjects treated with ALX1-11 and receiving calcium supplementation
This is a double-blind multi-centered randomized placebo-controlled parallel-group study comprised of 3 treatment groups ALX1-11 injection plus oral calcium ALX1-11 injection plus oral placebo calcium and placebo ALX1-11 injection plus oral calcium All subjects also receive 400 IU oral vitamin D3 The dose of ALX1-11 to be used in this study is 100 μg self administered by daily sc injection The calcium dose is 700 mgday
Additional supplemental calcium andor Vitamin D3 will not be permitted Patients will be monitored for the development of hypercalcemia andor hypercalciuria
The primary objective of this clinical study is to evaluate whether increases in bone mineral density BMD for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases in BMD observed for subjects treated with ALX1-11 and receiving calcium supplementation
A secondary objective of this clinical study are to evaluate whether changes in other efficacy parameters such as bone mineral content BMC and biochemical markers of bone turnover for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases observed for subjects treated with ALX1-11 and receiving calcium supplementation
This is a double-blind multi-centered randomized placebo-controlled parallel-group study comprised of 3 treatment groups ALX1-11 injection plus oral calcium ALX1-11 injection plus oral placebo calcium and placebo ALX1-11 injection plus oral calcium All subjects also receive 400 IU oral vitamin D3 The dose of ALX1-11 to be used in this study is 100 μg self administered by daily sc injection The calcium dose is 700 mgday
Additional supplemental calcium andor Vitamin D3 will not be permitted Patients will be monitored for the development of hypercalcemia andor hypercalciuria
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