Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018447
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-07-03
Brief Title:
Combination Osteogenic Therapy in Established Osteoporosis
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Combination Osteogenic Therapy in Established Osteoporosis
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to determine if combining parathyroid PTH 1-34 with fluoride MFPSR therapy in a cyclic treatment regimen will 1 produce a greater increase in bone density of the spine than would be produced by either treatment alone 2 prevent the resistance ie decreased bone formation and no further increase in bone density that is observed within 18-24 months of PTH therapy 3 eliminate the calcium deficiency and osteomalacia that can occur with fluoride 4 prevent excessive bone fluoride content and 5 result in an increase in bone density which is maintained after treatment is discontinued
Detailed Description:
This is a 3-yr single center open label active controlled randomized study of approximately 99 postmenopausal females with osteoporosis of spine or femoral neck Patients will be assigned to 1 of 3 groups 1 PTH 1-34 2 Fluoride 3 PTH and fluoride The treatment period is 3 years with 3-month cycles of therapy PTH will be administered subcutaneously by injection 600 units daily for 28 days the first month of each 3-month cycle Fluoride will be administered orally one 76mg tablet twice daily providing 20 mg fluorideday during the last 2 months of each cycle Calcium will be provided 800mgday during month 1 and 1500-2000mg for months 2 and 3 of each cycle
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