Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005005
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2000-03-24
Brief Title:
PaTH Study Parathyroid Hormone and Alendronate for Osteoporosis
Sponsor:
Dennis Black
Organization:
University of California San Francisco
Study Overview
Official Title:
Clinical Trial of Parathyroid Hormone PTH and Alendronate in Combination in the Treatment of Osteoporosis
Status:
COMPLETED
Status Verified Date:
2013-02
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:
This 2-year study will test the effectiveness of combining parathyroid hormone PTH and alendronate for treating osteoporosis in postmenopausal women Alendronate is a drug used to treat osteoporosis and primarily prevents bone loss whereas PTH increases bone formation We will treat the study participants either with PTH and alendronate alendronate alone or PTH alone We will determine the effects of these treatments by looking for changes in bone mineral density in the hip and spine
Detailed Description:
The PaTH study is a 2-year multicenter double-blind placebo-controlled trial to test the efficacy of combining hPTH 1-84 and alendronate for treating osteoporosis in postmenopausal women
238 women were randomized between 55 and 85 years of age to receive either 1 PTH for 1 year followed by alendronate for 1 year 2 PTH and alendronate for 1 year followed by alendronate for 1 year 3 alendronate for 2 years or 4 PTH for 1 year followed by placebo for 1 year The primary endpoints are changes in bone mineral density at several sites and changes in biochemical markers
In addition we will assess specific biochemical markers of bone turnover eg osteocalcin deoxypridinoline N-telopeptide bone-specific alkaline phosphatase and bone sialoprotein to determine if they can predict the skeletal response to combination therapy We will also determine whether PTH positively affects ultrasound measurements in the calcaneus
238 women were randomized between 55 and 85 years of age to receive either 1 PTH for 1 year followed by alendronate for 1 year 2 PTH and alendronate for 1 year followed by alendronate for 1 year 3 alendronate for 2 years or 4 PTH for 1 year followed by placebo for 1 year The primary endpoints are changes in bone mineral density at several sites and changes in biochemical markers
In addition we will assess specific biochemical markers of bone turnover eg osteocalcin deoxypridinoline N-telopeptide bone-specific alkaline phosphatase and bone sialoprotein to determine if they can predict the skeletal response to combination therapy We will also determine whether PTH positively affects ultrasound measurements in the calcaneus
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 |
|---|---|---|---|
| NIAMS-045 | US NIH GrantContract | None | httpsreporternihgovquickSearchN01AR002245-000 |
| N01AR002245-000 | NIH | None | None |