Health TrialsbyHealthPanel

Effect of Acetylcholinesterase Inhibitors on Bone Metabolism

ConditionOsteoporosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorDuke University

About this trial

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 assigned to donepezil 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of cognitive impairment, including clinical assessment, radiographic or labora-tory biomarker assessment

Willing to initiate treatment for cognitive impairment

A) For females: either age > 55 years, or Age < 55 years and at least 12 months since last menstrual period B) For males, age > 50 years

Geriatric Depression Scale score < 6

Disqualifiers

Currently on acetylcholinesterase inhibitor >3 months

History of bradycardia, heart block, long QT, unexplained syncope, or other contraindica-tion for donepezil; subject with ECG showing HR < 50, PR interval > 200 ms, QTc > 440 ms in men or > 460 ms in women, or evidence of atrioventricular block

Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teripar-atide, abaloparatide, romozosumab, calcitonin)

Use of bisphosphonate within last 5 years

Trial design

Design model

Single group

Treatments tested in this trial

  • Donepezil

    Drug

    10 mg tablet

  • Memantine

    Drug

    10 mg tablet

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: DonepezilExperimental treatment 1 intervention
Group B: MemantineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in bone mineral density, as measured by dual x-ray absorptiometry (DXA)

Time frame
baseline, 12 months

Secondary outcomes

1

Change in bone resorption marker C-terminal telopeptide (CTX)

measured using commercially available ELISA test on serum

Time frame
baseline, 6 months, 12 months
2

Change in bone formation marker amino-terminal propeptide of type I procollagen (P1NP)

measured using commercially available ELISA test on serum

Time frame
baseline, 6 months, 12 months
3

Change in Trabecular Bone score

measure of bone quality, using DXA spine images

Time frame
baseline, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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