Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172081
Status:
COMPLETED
Last Update Posted:
2021-05-14
First Post:
2005-09-09
Brief Title:
TOP Recombinant Human Parathyroid Hormone ALX1-11 on Fracture Incidence in Women With Postmenopausal Osteoporosis
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
An 18-Month Double-Blind Placebo-Controlled Phase III Trial With a 12-Month Interim Analysis of the Effect of Recombinant Human Parathyroid Hormone ALX1-11 on Fracture Incidence in Women With Postmenopausal Osteoporosis
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:
None
Brief Summary:
This is an 18-month double-blind placebo-controlled Phase III trial with a 12-month interim analysis of the effect of ALX1-11 recombinant human parathyroid hormone 1-84 rhPTH 1-84 on fracture incidence in women with postmenopausal osteoporosis the TOP study
Detailed Description:
Parathyroid hormone PTH a polypeptide consisting of 84 amino acids that is synthesized and secreted by the parathyroid glands is a principal regulator of calcium homeostasis through concerted action on kidney intestine and bone Parathyroid hormone exerts its action on bone to release calcium into the extracellular fluid as a process of bone remodeling and also to maintain the serum calcium concentration but the exact mechanisms are not fully understood In some circumstances PTH may exert an anabolic action on bone and can stimulate osteoblast proliferation and mature osteoblast function The net effect of exogenous PTH administration on bone turnover depends on the pattern of delivery A continuous long-term infusion gives a net decrease in trabecular bone volume whereas daily single injections result in a net increase
NPS Allelix Corp is developing ALX1-11 recombinant human parathyroid hormone 1-84 for the treatment of osteoporosis ALX1-11 is identical to the endogenous intact 84 amino acid human hormone and will be self-administered on a daily basis by subcutaneous sc injection
Currently there is no approved therapy for osteoporosis capable of stimulating the formation of new bone of normal composition and structure Most therapies in development are anti-catabolic and only prevent further bone loss eg estrogen replacement bisphosphonates and calcitonins ALX1-11 has the potential to stimulate new bone formation in osteoporotic patients thereby increasing bone mass and preventing fractures Patients with moderately or severely reduced bone density and a fracture would be expected to benefit from treatment thereby improving functional status and alleviating symptoms
NPS Allelix Corp is developing ALX1-11 recombinant human parathyroid hormone 1-84 for the treatment of osteoporosis ALX1-11 is identical to the endogenous intact 84 amino acid human hormone and will be self-administered on a daily basis by subcutaneous sc injection
Currently there is no approved therapy for osteoporosis capable of stimulating the formation of new bone of normal composition and structure Most therapies in development are anti-catabolic and only prevent further bone loss eg estrogen replacement bisphosphonates and calcitonins ALX1-11 has the potential to stimulate new bone formation in osteoporotic patients thereby increasing bone mass and preventing fractures Patients with moderately or severely reduced bone density and a fracture would be expected to benefit from treatment thereby improving functional status and alleviating symptoms
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