Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004358
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Study of Calcitonin for Tumoral Calcinosis
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-12
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:
OBJECTIVES I Determine whether intermittent long-term subcutaneous administration of calcitonin increases phosphaturia reduces hyperphosphatemia and increases intact parathyroid hormone levels in patients with tumoral calcinosis
II Determine whether calcitonin reduces or prevents tumor recurrence III Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus
IV Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis
II Determine whether calcitonin reduces or prevents tumor recurrence III Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus
IV Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis
Detailed Description:
PROTOCOL OUTLINE Patients are treated with subcutaneous injections of salmon calcitonin every 3 weeks Ondansetron premedication and intravenous hydration are also administered
Patients are followed for disease progression and tumor recurrence
Patients are followed for disease progression and tumor recurrence
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 |
|---|---|---|---|
| NU-477 | None | None | None |