Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264609
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-20
First Post:
2024-02-09
Brief Title:
Precision Medicine Approach for Osteoporosis - Follow Up Study
Sponsor:
Hartmut Malluche MD
Organization:
University of Kentucky
Study Overview
Official Title:
Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover - Follow Up Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
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:
Osteoporosis is a health problem of major proportions It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone Hospital admissions for osteoporotic fractures exceed those of heart attacks strokes and breast cancer combined Osteoporosis is commonly considered a disease associated with menopause This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation It is in contrast to age-related bone loss which starts as early as in the fourth decade of life and continues with increasing age Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality
Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status Thus the current standard of care relies on starting with an antiresorber which is of limited effectiveness in age-related osteoporosis and in fact impedes the effectiveness of the appropriate anabolic medication In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover EIRB70781 efforts are focused on addressing this particular problem
Our follow-up study seeks to achieve one specific aim to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one to the other drug at year two for the same duration of treatment
Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status Thus the current standard of care relies on starting with an antiresorber which is of limited effectiveness in age-related osteoporosis and in fact impedes the effectiveness of the appropriate anabolic medication In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover EIRB70781 efforts are focused on addressing this particular problem
Our follow-up study seeks to achieve one specific aim to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one to the other drug at year two for the same duration of treatment
Detailed Description:
This will be a prospective longitudinal crossover trial for participants who have completed therapy in the main trial - Novel precision medicine approach to treatment of osteoporosis based on bone turnover EIRB70781
Participants will be informed of the continuation follow-up study at enrollment into the main trial Participants will be approached for further participation in the continuation trial near the end of the initial 12 months treatment period Consent will be obtained at the final visit of the main trial and crossover therapy will be initiated at that time
Participants in Group 1 low turnover who have received Teriparatide in the main trial and if it is determined that the participant did not respond well to therapy will be assigned to Alendronate for 12 months Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant did not respond well to therapy will be assigned to Teriparatide for 12 months Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant responded to therapy will be continued on Alendronate for 12 months
Participants will be informed of the continuation follow-up study at enrollment into the main trial Participants will be approached for further participation in the continuation trial near the end of the initial 12 months treatment period Consent will be obtained at the final visit of the main trial and crossover therapy will be initiated at that time
Participants in Group 1 low turnover who have received Teriparatide in the main trial and if it is determined that the participant did not respond well to therapy will be assigned to Alendronate for 12 months Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant did not respond well to therapy will be assigned to Teriparatide for 12 months Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant responded to therapy will be continued on Alendronate for 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None