Back to resultsEffect of Acetylcholinesterase Inhibitors on Bone Metabolism
Primary Purpose
Osteoporosis
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Donepezil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria: Diagnosis of ADRD, including clinical assessment and either radiographic or laboratory biomarker assessment Meets NIA-AA clinical dementia criteria Willing to initiate treatment with AchEI for ADRD MoCA score < 24 For females, either age > 55 years, or Age < 55 years and at least 12 months since last menstrual period For males, age > 50 years Geriatric Depression Scale score < 6 Exclusion Criteria: Currently on acetylcholinesterase inhibitor Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teripar-atide, abaloparatide, romozosumab) Use of bisphosphonate within last 2 years Use within last 6 months of estrogens or testosterone, androgen deprivation therapy or aromatase inhibitors, antiepileptic, heparin therapy, thiazolidinediones History of disorders associated with osteoporosis: collagen vascular diseases, malab-sorption, inflammatory bowel disease, severe liver disease/cirrhosis, hyperthyroidism (endogenous or exogenous) History of hip fracture, hip replacement, or non-ambulatory Long-term use (>6 months) of corticosteroids History of Parkinson's, HIV, Huntington's disease History of solid organ transplantation Severe kidney impairment (eGFR < 30 ml/sec), Active malignancy, except non-melanomatous skin cancer 1-year mortality > 25%, measured by ePrognosis calculator Initiation of investigational or FDA-approved anti-amyloid drug
Sites / Locations
- Duke Memory Disorders Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Donepezil
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in bone mineral density, as measured by dual x-ray absorptiometry (DXA)
Secondary Outcome Measures
Change in bone resorption marker C-terminal telopeptide (CTX)
measured using commercially available ELISA test on serum
Change in bone formation marker amino-terminal propeptide of type I procollagen (P1NP)
measured using commercially available ELISA test on serum
Change in Trabecular Bone score
measure of bone quality, using DXA spine images
Full Information
NCT ID
NCT06041789
First Posted
September 11, 2023
Last Updated
September 11, 2023
Sponsor
Duke University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT06041789
Brief Title
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism
Official Title
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism and Fracture Risk Factors Among Older Adults With Mild to Moderate Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
People with Alzheimer's disease are at an increased risk of bone fracture. Some studies have shown that those taking donepezil have a lower rate of bone fractures, but the reasons for this are unknown. The purpose of this study is to measure the effect of donepezil treatment on bone metabolism factors including bone mineral density, bone turnover markers, and bone quality.
Participants in this study will have a bone density test and have blood samples collected at the baseline study visit. Participants will then be randomly assigned to donepezil or matching placebo to be taken daily by mouth for 12 months. Blood samples will be collected at 6 and 12 months. A repeat bone density test will be performed at 12 months. Participants will also complete questionnaires at each study visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Donepezil
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Donepezil
Intervention Description
10 mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Donepezil placebo tablet
Primary Outcome Measure Information:
Title
Change in bone mineral density, as measured by dual x-ray absorptiometry (DXA)
Time Frame
baseline, 12 months
Secondary Outcome Measure Information:
Title
Change in bone resorption marker C-terminal telopeptide (CTX)
Description
measured using commercially available ELISA test on serum
Time Frame
baseline, 6 months, 12 months
Title
Change in bone formation marker amino-terminal propeptide of type I procollagen (P1NP)
Description
measured using commercially available ELISA test on serum
Time Frame
baseline, 6 months, 12 months
Title
Change in Trabecular Bone score
Description
measure of bone quality, using DXA spine images
Time Frame
baseline, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ADRD, including clinical assessment and either radiographic or laboratory biomarker assessment
Meets NIA-AA clinical dementia criteria
Willing to initiate treatment with AchEI for ADRD
MoCA score < 24
For females, either age > 55 years, or Age < 55 years and at least 12 months since last menstrual period
For males, age > 50 years
Geriatric Depression Scale score < 6
Exclusion Criteria:
Currently on acetylcholinesterase inhibitor
Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teripar-atide, abaloparatide, romozosumab)
Use of bisphosphonate within last 2 years
Use within last 6 months of estrogens or testosterone, androgen deprivation therapy or aromatase inhibitors, antiepileptic, heparin therapy, thiazolidinediones
History of disorders associated with osteoporosis: collagen vascular diseases, malab-sorption, inflammatory bowel disease, severe liver disease/cirrhosis, hyperthyroidism (endogenous or exogenous)
History of hip fracture, hip replacement, or non-ambulatory
Long-term use (>6 months) of corticosteroids
History of Parkinson's, HIV, Huntington's disease
History of solid organ transplantation
Severe kidney impairment (eGFR < 30 ml/sec),
Active malignancy, except non-melanomatous skin cancer
1-year mortality > 25%, measured by ePrognosis calculator
Initiation of investigational or FDA-approved anti-amyloid drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Connie Thacker
Phone
(919) 681-9807
Email
connie.thacker@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard H Lee, MD, MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Memory Disorders Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Connie Thacker
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Acetylcholinesterase Inhibitors on Bone Metabolism
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