Using romosozumab to improve bone health in young women with hormone-related amenorrhea
Official title: Romosozumab as an adjunct to physiologic estrogen replacement in adolescents and young adults with functional hypothalamic amenorrhea
Funded at Massachusetts General Hospital · NIH-11162285 · Data updated 2026-11-12
This study is looking at whether a medication called romosozumab can help young women with functional hypothalamic amenorrhea build stronger bones, and participants will receive monthly injections along with some extra support like estrogen and vitamins for six months.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Massachusetts General Hospital NIH-funded |
| Lab location | 1 site (Boston, United States) |
| Project start | August 6, 2024 |
| Project end | April 30, 2029 |
| Funding year | 2025 |
| Award (this year) | $608,114 |
| NIH project number | 5R01HD114914-02 |
| Project ID | NIH-11162285 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are adolescent and young adult women aged 12 to 21 who have been diagnosed with functional hypothalamic amenorrhea.
✕Less likely to help
Patients who are not experiencing amenorrhea or those who are outside the age range of 12 to 21 may not benefit from this research.
What this research studies
This research investigates the effects of romosozumab, a medication that promotes bone formation, in adolescents and young adult women who experience functional hypothalamic amenorrhea (FHA). Participants will receive monthly injections of romosozumab or a placebo for six months, alongside transdermal estrogen replacement therapy and calcium and vitamin D supplementation. The study aims to assess changes in bone mineral density and overall bone health using advanced imaging techniques. By comparing the results with normal-weight controls, the research seeks to determine if romosozumab can help these young women achieve healthier bone mass.
Why it matters
Potential benefit: If successful, this research could significantly improve bone health and reduce the risk of osteoporosis in young women with FHA.
How similar studies have gone: Previous research has shown promising results with similar treatments for improving bone density in populations with hormonal imbalances, suggesting potential for success in this study.
Where this research is happening
-
Massachusetts General Hospital
Boston, United States Active
Researchers
- Principal investigator: Miller, Karen K — Massachusetts General Hospital
- Study coordinator: Miller, Karen K
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.