Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00138983
Status:
COMPLETED
Last Update Posted:
2006-11-29
First Post:
2005-08-29
Brief Title:
Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases Alendronate Versus Alfacalcidol
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases The STOP-Study a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol
Status:
COMPLETED
Status Verified Date:
2000-03
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:
The purpose of this study is to determine wich treatment is the most effective in prevention of glucocorticoid-induced osteoporosis in patients with rheumatic diseases The STOP-study a randomized placebo controlled trial with alendronate versus alfacalcidol
Detailed Description:
Treatment with glucocorticoids GCs is associated with bone loss initiated already early in therapy causing increased vertebral fracture risk Bone loss is caused by inhibition of bone formation by GCs Active vitamin D analogues like alfacalcidol directly stimulate osteoblasts leading to an increase in bone formation Bisphosphonates like alendronate induce apoptosis of osteoclasts leading to inhibition of bone resorption
We performed a randomized double-placebo double-blind clinical trial of 18 months duration in patients with a rheumatic disease starting GCs in a dosage of 75 mg prednisone equivalent daily or higher Two hundred one patients were allocated to receive either alendronate 10 mg and alfacalcidol-placebo daily or alfacalcidol 1 microgram and alendronate-placebo daily Primary outcome was change in bone mineral density of the lumbar spine in 18 months secondary outcome incidence of symptomatic morphometric vertebral deformities
We performed a randomized double-placebo double-blind clinical trial of 18 months duration in patients with a rheumatic disease starting GCs in a dosage of 75 mg prednisone equivalent daily or higher Two hundred one patients were allocated to receive either alendronate 10 mg and alfacalcidol-placebo daily or alfacalcidol 1 microgram and alendronate-placebo daily Primary outcome was change in bone mineral density of the lumbar spine in 18 months secondary outcome incidence of symptomatic morphometric vertebral deformities
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