Phase 2 Osteoporosis Trial, Recruiting NCT06041789 Sponsor: Duke University Condition: Osteoporosis
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Phase 2 Osteoporosis Trial, Recruiting

NCT06041789
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with cognitive impairment, confirmed through clinical assessment, brain imaging, or lab tests
  • People who are willing to start treatment for their cognitive impairment
  • Women who are either older than 55 years, or under 55 years and have not had a menstrual period for at least 12 months
  • Men who are older than 50 years
  • People who scored less than 6 on a standard depression screening tool called the Geriatric Depression Scale
  • People who speak English

Who may not be able to join:

  • People who are currently taking certain memory medications called acetylcholinesterase inhibitors or memantine
  • People with a history of certain heart conditions, including a slow heart rate, heart block, long QT syndrome, unexplained fainting, or other reasons a doctor would advise against taking donepezil; or people whose heart trace (ECG) shows certain abnormal readings (confirm with trial site)
  • People who are currently taking medication for osteoporosis (such as bisphosphonates, denosumab, teriparatide, or similar)
  • People who have used a bisphosphonate medication at any point in the last 5 years
  • People who have used any of the following in the last 6 months: oestrogen or testosterone therapies, hormone-blocking cancer treatments, anti-epileptic medications, heparin blood thinners, or a diabetes drug called thiazolidinediones
  • People with a history of certain conditions that can affect bone health, including connective tissue diseases, malabsorption conditions, inflammatory bowel disease, severe liver disease, or an overactive thyroid
  • People who have previously broken a bone in their upper arm, wrist, or spine from a fall from standing height or lower
  • People who have had a hip fracture or hip replacement, or who are unable to walk
  • People who have taken corticosteroid medications long-term (more than 6 months)
  • People with a history of Parkinson's disease, HIV, or Huntington's disease
  • People who have had a solid organ transplant
  • People who have had bariatric (weight loss) surgery, or who are planning to have it or start weight loss medication (such as GLP-1 drugs) within the next 12 months
  • People with severe kidney problems (confirm with trial site for specific test values)
  • People with an active cancer currently being treated with chemotherapy, surgery, or radiation — except for certain non-serious skin cancers
  • People whose estimated risk of passing away within one year is greater than 25%, as calculated by a specific medical tool called ePrognosis
  • People who are planning to move out of the local area within the next 12 months
  • People who are planning to have surgery within the next 12 months

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Richard H Lee, MD, MPH, Duke University

Phone: (919) 681-9807

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
3 February 2025
Est. completion
1 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov