A Phase 2 interventional study of Donepezil and Memantine in Osteoporosis, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Duke University · Phase 2, Interventional, and Treatment
Among 481 studies in Osteoporosis with a site in United States — 26 open to participants now, 36 under way, none of them phase 3. Osteoporosis · United States.
Among the 481 studies in Osteoporosis with a site in United States, this one is the 247th largest by planned enrollment of the 374 interventional ones, is one of 5 that started in 2025, is one of 73 in phase 2, reaches primary completion later than 17 of the 34 other live ones, and was the 459th registered.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's planned enrollment of 45 is below the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →26 of the 481 studies in Osteoporosis with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 132 Osteoporosis studies recruiting now, 76 (58%) set no upper age limit and 20 (15%) stop at 75 or younger; 9 take children under 18; 36 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →481 studies; the count open now beside each. This study's row is marked.
First in 1985; this study’s year is marked. 5 started in 2025.
Median enrollment 73 across the 374 interventional studies, 100 across the 97 observational. Of the 405 that completed or were terminated, 154 (38%) have results posted.
112 of 481 have an industry lead sponsor. The 10 most frequent:
Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Duke University has 5 studies filed under Osteoporosis — fewer than ten, so there is no comparison to draw.
15 of the studies in Osteoporosis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06577935Angitia BiopharmaceuticalsA Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS) | 2026-12 |
| NCT07325578Precision IO GroupU.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures | 2027-01 |
| NCT05704036Johns Hopkins UniversityEstrogen Supplementation and Bone Health in Women With CF | 2027-01 |
| NCT05151484Madhumathi RaoNovel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover | 2027-01-31 |
| NCT07154719Pennington Biomedical Research CenterGLP-1R Actions on Muscle and the Skeleton | 2027-02-01 |
Among the 481 studies in Osteoporosis with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Donepezil
Drug: Memantine
Change in bone mineral density, as measured by dual x-ray absorptiometry (DXA)
Time frame: baseline, 12 months
Change in bone resorption marker C-terminal telopeptide (CTX)
measured using commercially available ELISA test on serum
Time frame: baseline, 6 months, 12 months
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
Change in Trabecular Bone score
measure of bone quality, using DXA spine images
Time frame: baseline, 12 months
Plan to share: No
Started Feb 2025 (actual). Primary completion is estimated for Sep 2027, 31 months after the start.
Of 33 non-industry phase 2 interventional studies under Osteoporosis, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 65. This study's planned 31 months is below that.
Counting every sponsor, half of 42 studies reached it within 47 months; a quarter within 29 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Donepezil