Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT06018467
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2023-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Senolytics to Improve Osteoporosis Therapy
Sponsor:
Odense University Hospital
Organization:
Study Overview
Official Title:
SENolytics to Improve Osteoporosis Therapy: a Randomised Controlled Clinical Trial The SENIOR Trial
Status:
RECRUITING
Status Verified Date:
2025-07
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:
SENIOR
Brief Summary:
This randomised clinical trial aims to study osteoporosis as a disease of accelerated skeletal aging caused by the accumulation of senescent cells within the skeleton and investigate the effects and safety of senolytics and antioxidant therapy on bone.
Detailed Description:
Background, hypothesis, and aim:
Evidence suggests that it is feasible to alleviate chronic age-related disorders by targeting the biology of aging. Recent studies implicate cellular senescence at the nexus of skeletal aging, suggesting that selectively eliminating senescent cells may emerge as a conceptually novel approach to manage the enormous problem of age-related bone loss. In addition, previous studies have demonstrated that antioxidants inhibit cellular senescence. The aim of this randomised clinical trial is to study osteoporosis as a disease of accelerated skeletal aging caused by accumulation of senescent cells within the skeleton and investigate the effects and safety of senolytics and antioxidant therapy on bone.
The main trial endpoint is the percent change in circulating marker of bone resorption (CTX) measured at baseline and at week 21. Secondary endpoints are the changes in bone resorption marker tartrate resistant acid phosphatase (TRAcP) and bone formation markers (PINP, osteocalcin, and bone alkaline phosphatase) measured at baseline and at 21 weeks.
Trial design:
The study design is a randomised controlled open-label clinical trial. Study participants will be randomised 1:1:1 to one of three treatment groups, that will include either,
1. a combination of 100 mg/d dasatinib (oral) for two consecutive days and 1.250 mg/d quercetin (oral) for three consecutive days followed by 25 days without treatment, with treatment being repeated every 4 weeks for a total of 20 weeks (i.e., 5 times), or
2. treatment with 1 g nicotinamide riboside (NR) (oral) daily for 20 weeks, or
3. no treatment for 20 weeks.
Each participant will have a total of 7 to 10 visits at the clinical site. Blood samples will be obtained at all but one visit (2x20 ml each time). ECG will be performed at 6 visits for group 1 and at 2 visits for group 2 and 3. Scans will be performed at the first two and the last visit. Muscle-function tests will be performed at 2nd and last visit. Bone biopsies for RNA-sequencing (a technique indicating which of the genes encoded in our DNA that are active) will be collected in those that provide a separate consent and in up to 20 participants in each group (using block randomisation to ensure balanced distribution of sex and age, equaling a maximum of 60 biopsies.
Evidence suggests that it is feasible to alleviate chronic age-related disorders by targeting the biology of aging. Recent studies implicate cellular senescence at the nexus of skeletal aging, suggesting that selectively eliminating senescent cells may emerge as a conceptually novel approach to manage the enormous problem of age-related bone loss. In addition, previous studies have demonstrated that antioxidants inhibit cellular senescence. The aim of this randomised clinical trial is to study osteoporosis as a disease of accelerated skeletal aging caused by accumulation of senescent cells within the skeleton and investigate the effects and safety of senolytics and antioxidant therapy on bone.
The main trial endpoint is the percent change in circulating marker of bone resorption (CTX) measured at baseline and at week 21. Secondary endpoints are the changes in bone resorption marker tartrate resistant acid phosphatase (TRAcP) and bone formation markers (PINP, osteocalcin, and bone alkaline phosphatase) measured at baseline and at 21 weeks.
Trial design:
The study design is a randomised controlled open-label clinical trial. Study participants will be randomised 1:1:1 to one of three treatment groups, that will include either,
1. a combination of 100 mg/d dasatinib (oral) for two consecutive days and 1.250 mg/d quercetin (oral) for three consecutive days followed by 25 days without treatment, with treatment being repeated every 4 weeks for a total of 20 weeks (i.e., 5 times), or
2. treatment with 1 g nicotinamide riboside (NR) (oral) daily for 20 weeks, or
3. no treatment for 20 weeks.
Each participant will have a total of 7 to 10 visits at the clinical site. Blood samples will be obtained at all but one visit (2x20 ml each time). ECG will be performed at 6 visits for group 1 and at 2 visits for group 2 and 3. Scans will be performed at the first two and the last visit. Muscle-function tests will be performed at 2nd and last visit. Bone biopsies for RNA-sequencing (a technique indicating which of the genes encoded in our DNA that are active) will be collected in those that provide a separate consent and in up to 20 participants in each group (using block randomisation to ensure balanced distribution of sex and age, equaling a maximum of 60 biopsies.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: