Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005006
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2000-03-24
Brief Title:
Parathyroid Hormone PTH With Alendronate for Osteoporosis
Sponsor:
Helen Hayes Hospital
Organization:
Helen Hayes Hospital
Study Overview
Official Title:
Cyclical vs Daily Continuous PTH in Combination With Alendronate vs Alendronate Alone
Status:
COMPLETED
Status Verified Date:
2015-08
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 study investigates the effectiveness of parathyroid hormone PTH in combination with alendronate a standard treatment for osteoporosis that blocks or reduces bone loss We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion The entire study is 21 months long the active treatment period is 18 months with a 6-month followup period
The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown and changes in bone density throughout the skeleton We will randomly assign all study participants who are women aged 50 and over to either stay on alendronate alone receive daily continuous PTH plus alendronate or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate
The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown and changes in bone density throughout the skeleton We will randomly assign all study participants who are women aged 50 and over to either stay on alendronate alone receive daily continuous PTH plus alendronate or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate
Detailed Description:
Osteoporosis is a significant disease because it increases the risk of fractures throughout the skeleton most importantly in the spine and hip regions The current medications for osteoporosis which include estrogens bisphosphonates raloxifene and calcitonin all primarily prevent bone loss although each may be associated with small bone gains Another class of drugs the anabolic drugs will increase bone formation more substantially leading to bigger gains in bone mass One of these sodium fluoride clearly increases bone mass but may or may not reduce fracture risk Another bone-forming agent is human parathyroid hormone PTH We and others have demonstrated substantial bone mass gains as well as a reduction in vertebral fracture with the use of PTH administered by daily subcutaneous injection
The current study seeks to capitalize on the knowledge gleaned about PTH-induced stimulation of bone formation prior to resorption in subjects on antiresorptive therapy such as estrogen or alendronate In this protocol we have chosen to give PTH by daily subcutaneous injection in the presence of alendronate We have already shown that with 6 weeks of daily subcutaneous h1-34PTH 400 Uday in patients on established alendronate biochemical indicators of bone formation are substantially increased 30-60 percent with no stimulation of resorption over this time frame
We hypothesize that over 3 months the combination of PTH plus alendronate will like the combination of PTH plus hormone replacement therapy result in increments in bone formation exceeding those of bone resorption We also theorize that this biochemical profile will be reflected in a greater effect on bone mass than during therapy with alendronate alone when both formation and resorption are elevated Furthermore we believe that the changes over the first 3 months can be repeated over additional discrete 3-months cycles after bone turnover returns to baseline
Therefore we plan to study the difference in bone mass and biochemical indicators of bone turnover when in the presence of established alendronate therapy we give PTH by daily subcutaneous injection continuously for 15 months in which bone resorption is elevated substantially for more than half of the time versus discontinuously in three discrete 3-month cycles in which bone formation will dramatically exceed bone resorption for the entire treatment period
The candidates for this study are postmenopausal women who have osteoporosis defined by either bone density andor prior osteoporotic fracture occurrence and in addition have used alendronate for at least 18 months prior to entering into the study Patients must be over the age of 50
The entire study is 21 months long the active treatment period is 18 months with a 6- month followup period The primary outcomes in this study are biochemistry and bone density throughout the skeleton We will randomly assign all participants to either remain on alendronate alone receive daily continuous PTH plus alendronate or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH both with PTH given in addition to daily or weekly alendronate
The current study seeks to capitalize on the knowledge gleaned about PTH-induced stimulation of bone formation prior to resorption in subjects on antiresorptive therapy such as estrogen or alendronate In this protocol we have chosen to give PTH by daily subcutaneous injection in the presence of alendronate We have already shown that with 6 weeks of daily subcutaneous h1-34PTH 400 Uday in patients on established alendronate biochemical indicators of bone formation are substantially increased 30-60 percent with no stimulation of resorption over this time frame
We hypothesize that over 3 months the combination of PTH plus alendronate will like the combination of PTH plus hormone replacement therapy result in increments in bone formation exceeding those of bone resorption We also theorize that this biochemical profile will be reflected in a greater effect on bone mass than during therapy with alendronate alone when both formation and resorption are elevated Furthermore we believe that the changes over the first 3 months can be repeated over additional discrete 3-months cycles after bone turnover returns to baseline
Therefore we plan to study the difference in bone mass and biochemical indicators of bone turnover when in the presence of established alendronate therapy we give PTH by daily subcutaneous injection continuously for 15 months in which bone resorption is elevated substantially for more than half of the time versus discontinuously in three discrete 3-month cycles in which bone formation will dramatically exceed bone resorption for the entire treatment period
The candidates for this study are postmenopausal women who have osteoporosis defined by either bone density andor prior osteoporotic fracture occurrence and in addition have used alendronate for at least 18 months prior to entering into the study Patients must be over the age of 50
The entire study is 21 months long the active treatment period is 18 months with a 6- month followup period The primary outcomes in this study are biochemistry and bone density throughout the skeleton We will randomly assign all participants to either remain on alendronate alone receive daily continuous PTH plus alendronate or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH both with PTH given in addition to daily or weekly alendronate
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 |
|---|---|---|---|
| Subproject 5 | US NIH GrantContract | None | httpsreporternihgovquickSearchP50AR039191 |
| P50AR039191 | NIH | None | None |
| NIAMS-019 | None | None | None |