Ignite Creation Date:
2024-05-06 @ 12:52 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03868033
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2019-03-06
Brief Title:
Denosumab Sequential Therapy
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Department of Orthopedics National Taiwan University Hospital
Status:
COMPLETED
Status Verified Date:
2023-09
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:
DST
Brief Summary:
Denosumab is a potent anti-resorptive agent and is now widely used in the treatment of osteoporosis Although denosumab has excellent effect to increase bone mass and prevent fracture in FREEDOM study with very low complications even up to ten years its effect is reversible After holding the drug circulating denosumab levels fall rapidly and bone resorption reaching twice baseline levels for about 6 months How to prevent bone loss after denosumab therapy is an important issue especially when considering the compliance persistence or other comorbidities of the patient We want to verify if zoledronic acid could be used as a sequential therapy after denosumab to prevent rapid bone loss by randomized clinical trial
Detailed Description:
Denosumab is a monoclonal antibody directed against the protein RANK-L the principal regulator of osteoclast development Thus it acts as a potent anti-resorptive agent and is now widely used in the treatment of osteoporosis Because its easily to be used with very low risk of complications patient has better compliance and persistence of denosumab than bisphosphonates Its market share increasing very rapidly in Taiwan
Although denosumab has excellent effect to increase bone mass and prevent fracture in FREEDOM study with very low complications even up to ten years its effect is reversible After holding the drug circulating denosumab levels fall rapidly and bone resorption reaching twice baseline levels for about 6 months Over the first 12 months off therapy all the bone density gained on treatment is lost4 According to previous meta-analysis study although the persistence of denosumab therapy is better than bisphosphonates only 62 patients keep the treatment after two years We could image how low the persistence is after five-year or ten-year treatment in the real world
How to prevent bone loss after denosumab therapy is an important issue especially when considering the compliance persistence or other comorbidities of the patient There is only one randomized controlled trial dealing with this problem although the primary goal of the study is designed to compare the compliance and persistence1 After switching from denosumab to alendronate for one year bone mineral density does not decrease rapidly although there is mild elevation of bone turn over marker
We want to verify if zoledronic acid could be used as a sequential therapy after denosumab to prevent rapid bone loss by randomized clinical trial
Although denosumab has excellent effect to increase bone mass and prevent fracture in FREEDOM study with very low complications even up to ten years its effect is reversible After holding the drug circulating denosumab levels fall rapidly and bone resorption reaching twice baseline levels for about 6 months Over the first 12 months off therapy all the bone density gained on treatment is lost4 According to previous meta-analysis study although the persistence of denosumab therapy is better than bisphosphonates only 62 patients keep the treatment after two years We could image how low the persistence is after five-year or ten-year treatment in the real world
How to prevent bone loss after denosumab therapy is an important issue especially when considering the compliance persistence or other comorbidities of the patient There is only one randomized controlled trial dealing with this problem although the primary goal of the study is designed to compare the compliance and persistence1 After switching from denosumab to alendronate for one year bone mineral density does not decrease rapidly although there is mild elevation of bone turn over marker
We want to verify if zoledronic acid could be used as a sequential therapy after denosumab to prevent rapid bone loss by randomized clinical trial
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?:
True
Is an FDA AA801 Violation?:
None