Effect of Acetylcholinesterase Inhibitors on Bone Metabolism

Description

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.

Conditions

Osteoporosis

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Study Overview

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Study Details

Study overview

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.

Effect of Acetylcholinesterase Inhibitors on Bone Metabolism and Fracture Risk Factors Among Older Adults With Mild to Moderate Alzheimer's Disease

Effect of Acetylcholinesterase Inhibitors on Bone Metabolism

Condition
Osteoporosis
Intervention / Treatment

-

Contacts and Locations

Durham

Duke Memory Disorders Clinic, Durham, North Carolina, United States, 27705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Diagnosis of ADRD, including clinical assessment and either radiographic or laboratory biomarker assessment
  • 2. Meets NIA-AA clinical dementia criteria
  • 3. Willing to initiate treatment with AchEI for ADRD
  • 4. MoCA score \< 24
  • 5. For females, either age \> 55 years, or Age \< 55 years and at least 12 months since last menstrual period
  • 6. For males, age \> 50 years
  • 7. Geriatric Depression Scale score \< 6
  • 1. Currently on acetylcholinesterase inhibitor
  • 2. Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teripar-atide, abaloparatide, romozosumab)
  • 3. Use of bisphosphonate within last 2 years
  • 4. Use within last 6 months of estrogens or testosterone, androgen deprivation therapy or aromatase inhibitors, antiepileptic, heparin therapy, thiazolidinediones
  • 5. History of disorders associated with osteoporosis: collagen vascular diseases, malab-sorption, inflammatory bowel disease, severe liver disease/cirrhosis, hyperthyroidism (endogenous or exogenous)
  • 6. History of hip fracture, hip replacement, or non-ambulatory
  • 7. Long-term use (\>6 months) of corticosteroids
  • 8. History of Parkinson's, HIV, Huntington's disease
  • 9. History of solid organ transplantation
  • 10. Severe kidney impairment (eGFR \< 30 ml/sec),
  • 11. Active malignancy, except non-melanomatous skin cancer
  • 12. 1-year mortality \> 25%, measured by ePrognosis calculator
  • 13. Initiation of investigational or FDA-approved anti-amyloid drug

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Richard H Lee, MD, MPH, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

2025-06