Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074711
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2003-12-19
Brief Title:
Adding Phosphorus to Osteoporosis Drug Treatment
Sponsor:
Creighton University
Organization:
Creighton University
Study Overview
Official Title:
Bone Sparing by Calcium Salts With and Without Extra Phosphorus
Status:
COMPLETED
Status Verified Date:
2016-07
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:
Osteoporosis causes bones to weaken and break more easily Calcium and phosphorus are two minerals that are essential for normal bone formation Unfortunately calcium salts commonly prescribed in anti-osteoporosis treatment bind phosphorus from food and restrict phosphorus available for bone building Teriparatide is a drug that reduces the risk of fractures by increasing bone thickness and strength Vitamin D is also necessary for strong bones and teeth The purpose of this study is to evaluate the bone-building effectiveness of two calcium supplements one with a source of phosphorus and one without in combination with teriparatide and vitamin D in women with osteoporosis
Detailed Description:
Osteoporosis is the most common type of bone disease Calcium supplements normally used in anti-osteoporosis treatment are calcium salts of carbonate or citrate however these salts bind phosphorus from food in the intestine and restrict phosphorus available for bone building This study will evaluate the efficacy of adding calcium phosphate to a regimen of teriparatide and vitamin D in increasing bone mineral density in women with osteoporosis It is hypothesized that the group taking the phosphate-containing calcium supplement will have greater gains in bone mineral density BMD during the course of the study than the group not receiving phosphate
All participants will receive teriparatide and vitamin D during the course of the 12-month study Participants will be randomly assigned to one of two groups One group will receive calcium phosphate and the other will receive calcium carbonate BMD will be measured at spine and hip at baseline and at 3 6 and 12 months of treatment
All participants will receive teriparatide and vitamin D during the course of the 12-month study Participants will be randomly assigned to one of two groups One group will receive calcium phosphate and the other will receive calcium carbonate BMD will be measured at spine and hip at baseline and at 3 6 and 12 months of treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AR048846 | NIH | None | httpsreporternihgovquickSearchR01AR048846 |