Benefits and risks of long-term osteoporosis medicines, including taking breaks or switching drugs
Official title: Benefits and Harms of Long-term Osteoporosis Pharmacotherapy: Impact of Treatment Length, Type, Switching, and Holidays
Funded at Brown University · NIH-11131264 · Data updated 2026-11-12
This project compares continuing, pausing, or switching osteoporosis medicines to see how each approach affects fracture risk and serious side effects in older adults.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Brown University NIH-funded |
| Lab location | 1 site (Providence, United States) |
| Project start | September 15, 2022 |
| Project end | June 30, 2027 |
| Funding year | 2025 |
| Award (this year) | $476,397 |
| NIH project number | 5R01AG078759-04 |
| Project ID | NIH-11131264 on NIH RePORTER |
Who could benefit from this research
✓Could help
Older adults (generally 65 and older) who have been taking oral bisphosphonates for three or more years, including both community-dwelling people and nursing home residents, are the ideal candidates.
✕Less likely to help
People under age 65, those who have never used osteoporosis medications, or those not facing decisions about long-term therapy are unlikely to directly benefit from this project.
What this research studies
This project compares outcomes for older adults who have used oral bisphosphonates for at least three years to see what happens when people continue therapy, take a drug holiday, or switch to another osteoporosis medication. Researchers will measure fractures, serious consequences like death or entry into a nursing home, and rare harms such as atypical femoral fractures. The work includes both community-dwelling older adults and nursing home residents and aims to include groups underrepresented in past trials, such as men. The team will use large patient records and healthcare data to follow real-world treatment patterns and outcomes over time.
Why it matters
Potential benefit: If successful, this work could help older adults and their clinicians make safer, clearer decisions about when to stop, switch, or continue osteoporosis medicines to lower fracture risk and avoid rare harms.
How similar studies have gone: Prior clinical trials in women found little difference in fracture risk after stopping versus continuing bisphosphonates for 3–5 years, but long-term harms and evidence in men and nursing-home residents remain limited.
Where this research is happening
-
Brown University
Providence, United States Active
Researchers
- Principal investigator: Hayes, Kaleen Nicole — Brown University
- Study coordinator: Hayes, Kaleen Nicole
Related research
Other NIH-funded projects on the same topics.
-
Or olive-oil derived compound to prevent bone loss in women
A safe, orally taken nutraceutical may help prevent osteoporosis in adult women by supporting bone formation and reducing bone loss.
-
When to stop, switch, or pause long-term osteoporosis medicines for older adults
This project looks at whether stopping, switching, or taking breaks from long-term osteoporosis drugs changes fracture risk and side effects for older adults.
-
Cortical Bone Mechanics Technology to better screen for osteoporosis
A new noninvasive test called CBMT uses ulnar flexural rigidity to predict fracture risk better than standard bone density tests, helping adults who may be at risk for osteoporosis.
-
Gene therapy for osteoporosis linked to ALDH2 deficiency in postmenopausal East Asian women
A gene therapy approach is being developed to reduce osteoporosis risk in postmenopausal East Asian women who have ALDH2 deficiency and drink alcohol.
-
Metabolomics clues to osteoporosis risk in diverse populations
A study using small molecules in blood samples to understand osteoporosis risk, with a focus on aging, ethnicity, and sex differences.
-
Single-Cell Study of Bone Cells to Understand Osteoporosis
Researchers will study individual bone-related cells from people to uncover why aging leads to weaker bones and higher fracture risk.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.