Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004993
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2000-03-17
Brief Title:
Can Parathyroid Hormone Injections Reverse Glucocorticoid-induced Osteoporosis
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Can PTH Reverse Glucocorticoid-induced Osteoporosis
Status:
COMPLETED
Status Verified Date:
2010-03
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:
Glucocorticoids are potent anti-inflammatory and immunosuppressive agents However prolonged use of these potent agents results in severe bone loss and osteoporotic fractures Parathyroid hormone 1-34 when given as a daily injection has been found to dramatically increase bone mass in osteoporotic animals and postmenopausal women The purpose of this study is to determine whether 2 years of daily PTH 1-34 injections will increase bone mass and reduce the development of new fractures In addition we will follow the study subjects for 2 more years to determine which type of anti-resorptive agent is required to maintain the newly formed bone
We are enrolling postmenopausal women that are on chronic corticosteroid therapy prednisone etc and have bone loss osteopenia by DXA to be a part of this four-year-long study The patients will receive two-year therapy with either PTH 1-34 or placebo and for the second part of the study subjects receive either estrogen and placebo or alendronate and placebo We will measure bone gain by standard bone densitometry special x-rays of the spine and hip and serum and urine bone markers
We are enrolling postmenopausal women that are on chronic corticosteroid therapy prednisone etc and have bone loss osteopenia by DXA to be a part of this four-year-long study The patients will receive two-year therapy with either PTH 1-34 or placebo and for the second part of the study subjects receive either estrogen and placebo or alendronate and placebo We will measure bone gain by standard bone densitometry special x-rays of the spine and hip and serum and urine bone markers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DK46661 | None | None | None |