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New treatment option for Osteoporosis
Official title Effect of Acetylcholinesterase Inhibitors on Bone Metabolism
ClinicalTrials.gov ID: NCT06041789
What this study is testing
What is Donepezil?
Donepezil is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for osteoporosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Diagnosis of cognitive impairment, including clinical assessment, radiographic or laboratory biomarker assessment
- Willing to initiate treatment for cognitive impairment
- A) For females: either age \> 55 years, or Age \ 50 years
- Geriatric Depression Scale score \< 6
- English-speaking
You likely can't join if
- Currently on acetylcholinesterase inhibitor or memantine
- History of bradycardia, heart block, long QT, unexplained syncope, or other contraindication for donepezil; subject with ECG showing HR \ 200 ms, QTc...
- Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teriparatide, abaloparatide, romozosumab, calcitonin)
- Use of bisphosphonate within last 5 years
- Use within last 6 months of estrogens or testosterone, androgen deprivation therapy or aromatase inhibitors, antiepileptic, heparin therapy...
- History of disorders associated with secondary osteoporosis: collagen vascular diseases, malabsorption, inflammatory bowel disease, severe liver...
See the full eligibility criteria
- Diagnosis of cognitive impairment, including clinical assessment, radiographic or laboratory biomarker assessment
- Willing to initiate treatment for cognitive impairment
- A) For females: either age \> 55 years, or Age \ 50 years
- Geriatric Depression Scale score \< 6
- English-speaking
- Currently on acetylcholinesterase inhibitor or memantine
- History of bradycardia, heart block, long QT, unexplained syncope, or other contraindication for donepezil; subject with ECG showing HR \ 200 ms, QTc \> 440 ms in men or \> 460 ms in women, or evidence of...
- Currently on osteoporosis medication (e.g., bisphosphonate, SERM, denosumab, teriparatide, abaloparatide, romozosumab, calcitonin)
- Use of bisphosphonate within last 5 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 secondary osteoporosis: collagen vascular diseases, malabsorption, inflammatory bowel disease, severe liver disease/cirrhosis, hyperthyroidism (endogenous or exogenous)
- History of fracture of the humerus, wrist, or vertebra due to fall from standing height or less
- 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
- History of bariatric surgery or intending to lose weight by bariatric surgery or weight loss medication (e.g. GLP-1 agonist) in the next 12-months
- Severe kidney impairment (eGFR \< 30 ml/min),
- Active malignancy currently undergoing chemotherapeutic, surgical, or radiation therapy, except non-melanomatous skin cancer
- 1-year mortality \> 25%, measured by ePrognosis calculator
- Planning to move out of the area in the next 12-months
- Planning surgery in the next 12-months
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.