Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221299
Status:
COMPLETED
Last Update Posted:
2015-06-25
First Post:
2005-09-14
Brief Title:
Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Can Risedronate and Parathyroid Hormone Reverse Glucocorticoid Induced Osteoporosis
Status:
COMPLETED
Status Verified Date:
2015-06
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 the study is to learn if one year of treatment with parathyroid hormone PTH either alone or with risedronate will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use During the second year the study will also look at whether taking risedronate will preserve the bone thickness created by one year of rhPTH 1-34 treatment
Detailed Description:
Dr Nancy Lane and colleagues at the University of California Davis and University of California San Francisco will be conducting this 2-year study of human parathyroid hormone rhPTH 1-34 alone and rhPTH 1-34 with risedronate compared to risedronate alone in men and women with osteopenia on chronic low dose glucocorticoids GC This is an investigator-initiated study funded by Aventis Pharmaceuticals
The study will be divided into 2 phases All study subjects will receive supplemental calcium citrate and Vitamin D during the 2-year study In year one subjects will be randomly assigned to receive PTH subcutaneously daily or placebo and risedronate tablets or placebo In year two PTH will be stopped and subjects in group 1 will be re-randomized to receive risedronate tablets or placebo Subjects in group 2 and 3 will continue on risedronate tablets
In year one of the study subjects were randomly assigned to one of the following treatment groups
1 Group 1 rhPTH 1-34 20ug subcutaneously daily riesdronate placebo tablets
2 Group 2 rhPTh 1-34 20ug subcutaneously daily risedronate tablets 35mgwk
3 Group 3 rhPTh placebo subcutaneous injections of normal saline risedronate tablets 35mgwk
In year two of the study beginning at the 12 month timepoint
1 Group 1 subjects were re-randomized to either
Group 1a risedronate 35mgwk or Group 1b risedronate placebo
2 Group 2 subjects continued risedronate 35mgwk
3 Group 3 subjects continued risedronate 35mgwk
Potential study subjects will have dual x-ray absorptiometry measurements DEXA of the spine and hip at the screening visit Those study subjects who meet the inclusion criteria will be invited back for a baseline visit
DEXA scans of the spine hip and forearm will be done at Baseline visit 6-month 12-month 18-month and 24-month follow-up visits DEXA scan of the spine hip and forearm takes approximately 20 minutes to complete To assess incident vertebral and non-vertebral fractures lateral thoracic and lumbar spine evaluation using Instant Vertebral Assessment IVA will be done at Baseline 12-month and 24-month follow-up visits
The specific aims of the study are as follows
1 To determine if changes in bone mineral density in the spine and hip caused by 1 year of treatment with rhPTH 1-34 alone then followed by risedronate or rhPTH 1-34 with risedronate are greater than PTH placebo and risedronate in patients with GIO who are taking calcium MVIs and chronic low doses of glucocorticoids
2 To determine if risedronate will preserve the high bone mass state created by 1 year of rhPTH 1-34 treatment
3 To determine the association of biochemical markers of bone turnover with rhPTH 1-34 and risedronate both during and after treatment
4 To compare as possible the fracture incidence between the rhPTH 1-34 alone followed by risedronate and rhPTH 1-34 with risedronate compared to risedronate placebo groups
The study will be divided into 2 phases All study subjects will receive supplemental calcium citrate and Vitamin D during the 2-year study In year one subjects will be randomly assigned to receive PTH subcutaneously daily or placebo and risedronate tablets or placebo In year two PTH will be stopped and subjects in group 1 will be re-randomized to receive risedronate tablets or placebo Subjects in group 2 and 3 will continue on risedronate tablets
In year one of the study subjects were randomly assigned to one of the following treatment groups
1 Group 1 rhPTH 1-34 20ug subcutaneously daily riesdronate placebo tablets
2 Group 2 rhPTh 1-34 20ug subcutaneously daily risedronate tablets 35mgwk
3 Group 3 rhPTh placebo subcutaneous injections of normal saline risedronate tablets 35mgwk
In year two of the study beginning at the 12 month timepoint
1 Group 1 subjects were re-randomized to either
Group 1a risedronate 35mgwk or Group 1b risedronate placebo
2 Group 2 subjects continued risedronate 35mgwk
3 Group 3 subjects continued risedronate 35mgwk
Potential study subjects will have dual x-ray absorptiometry measurements DEXA of the spine and hip at the screening visit Those study subjects who meet the inclusion criteria will be invited back for a baseline visit
DEXA scans of the spine hip and forearm will be done at Baseline visit 6-month 12-month 18-month and 24-month follow-up visits DEXA scan of the spine hip and forearm takes approximately 20 minutes to complete To assess incident vertebral and non-vertebral fractures lateral thoracic and lumbar spine evaluation using Instant Vertebral Assessment IVA will be done at Baseline 12-month and 24-month follow-up visits
The specific aims of the study are as follows
1 To determine if changes in bone mineral density in the spine and hip caused by 1 year of treatment with rhPTH 1-34 alone then followed by risedronate or rhPTH 1-34 with risedronate are greater than PTH placebo and risedronate in patients with GIO who are taking calcium MVIs and chronic low doses of glucocorticoids
2 To determine if risedronate will preserve the high bone mass state created by 1 year of rhPTH 1-34 treatment
3 To determine the association of biochemical markers of bone turnover with rhPTH 1-34 and risedronate both during and after treatment
4 To compare as possible the fracture incidence between the rhPTH 1-34 alone followed by risedronate and rhPTH 1-34 with risedronate compared to risedronate placebo groups
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