Researchers studied a new bone-strengthening medication called romosozumab in 58 postmenopausal women with severe osteoporosis (weak bones). After 12 months of treatment, most women experienced significant improvements in bone density, with some gaining up to 15% more bone strength in their spine. Scientists used advanced computer analysis to figure out which patients benefited most from the treatment. The study found that the medication worked well for most women and that certain blood test results and medical history could predict who would respond best to the treatment.

The Quick Take

  • What they studied: Whether a new bone-strengthening drug called romosozumab actually works in real-world patients and which patients benefit the most from it
  • Who participated: 58 women over age 50 who had gone through menopause and had severe osteoporosis (very weak bones). The average age was about 72 years old, and they were treated at seven hospitals in Spain between May 2023 and November 2024
  • Key finding: The medication significantly strengthened bones in most women—spine bones improved by about 15%, hip bones by 12%, and total hip by about 9% after one year. About 4 out of 10 women achieved the best possible improvement (10% or more bone strength gain)
  • What it means for you: If you’re a postmenopausal woman with severe osteoporosis, romosozumab may help strengthen your bones and reduce fracture risk. However, this was a small study in Spain, so talk with your doctor about whether this medication is right for you based on your specific health situation

The Research Details

This was a real-world study that looked back at medical records from 58 women who received romosozumab treatment at seven hospitals in Spain. Researchers measured bone density using a special X-ray scan called DXA at the start of treatment and again after 12 months. They also collected blood tests to measure various bone-related chemicals in the body. To figure out which patients responded best, the researchers used advanced computer analysis (machine learning) that can identify patterns and explain why certain patients improved more than others.

This study design is important because it shows how the medication works in real patients in actual hospitals, not just in controlled research settings. The computer analysis helps doctors understand which patients are most likely to benefit, so they can make better treatment decisions. This type of analysis can identify patterns that humans might miss and explain those patterns in ways doctors can understand and use.

This study has some strengths: it looked at real-world patients across multiple hospitals, used standardized bone density measurements, and employed advanced analytical methods. However, the sample size is relatively small (58 women), which means results may not apply to all women. The study was conducted in Spain, so results may differ in other populations. There was no comparison group of women who didn’t receive the medication, which would have strengthened the findings. The study is recent (2023-2024), so long-term effects are unknown.

What the Results Show

The medication romosozumab produced strong improvements in bone density across different parts of the skeleton. At the lumbar spine (lower back), women gained an average of 15.35% more bone density. At the femoral neck (upper thighbone), they gained 12.42%. At the total hip, they gained 8.62%. These improvements are considered clinically meaningful, meaning they’re large enough to potentially reduce fracture risk. When researchers looked at how many women achieved the best-case scenario (10% or more improvement), they found that 39% reached this goal at the spine, 38% at the femoral neck, and 32% at the total hip. This means that while most women improved, not everyone achieved the highest level of response.

The computer analysis revealed important patterns about which patients responded best. Women who started with lower bone density actually showed greater improvements, suggesting the medication may be especially helpful for those with the most severe bone loss. Women with higher phosphate levels in their blood also tended to respond better. Interestingly, women who were younger when they went through menopause showed better responses to the medication. On the flip side, women with higher PTH (parathyroid hormone) or alkaline phosphatase levels showed smaller improvements. Additionally, women who had not taken corticosteroids or NSAIDs (pain medications like ibuprofen) in the six months before starting romosozumab had better results, possibly because these medications can interfere with bone health.

This real-world study confirms what earlier clinical trials suggested about romosozumab’s effectiveness. Previous research showed the medication could improve bone density, and this study demonstrates those benefits hold up in everyday medical practice. The bone density improvements reported here (15% at the spine) are consistent with or even slightly better than what was seen in controlled research studies. The identification of specific patient characteristics that predict good response is new and valuable information that wasn’t as clearly defined in previous studies.

The study included only 58 women, which is a relatively small number. This means the findings may not apply to all women with osteoporosis, especially those from different ethnic backgrounds or geographic regions. The study only followed patients for 12 months, so we don’t know if the benefits continue, improve, or decline over longer periods. There was no control group of women who didn’t receive the medication, making it impossible to know if some improvements might have happened naturally. The study was conducted in Spain, so results may differ in other countries with different populations. The computer analysis identified patterns, but these patterns need to be tested in other groups of patients to confirm they’re reliable.

The Bottom Line

For postmenopausal women with severe osteoporosis or high fracture risk, romosozumab appears to be an effective treatment option (moderate to high confidence based on this real-world evidence). The medication may be especially beneficial if you have very low bone density to start with, normal or low PTH levels, and haven’t been taking corticosteroids or NSAIDs recently. However, this is one study of 58 women, so discuss with your doctor whether this medication is appropriate for your individual situation. Your doctor can order blood tests to see if you match the patient characteristics that predict good response.

This research is most relevant to postmenopausal women over age 50 with severe osteoporosis or high fracture risk who are considering bone-strengthening medications. It’s also important for doctors who treat osteoporosis, as it provides guidance on which patients are most likely to benefit. Women who have already tried other osteoporosis medications without good results may want to discuss romosozumab with their doctor. This research is less relevant to men with osteoporosis or premenopausal women, as the study only included postmenopausal women.

Based on this study, you can expect to see meaningful improvements in bone density within 12 months of starting romosozumab. The average improvements were measured at the one-year mark. However, it typically takes several years of improved bone density to significantly reduce fracture risk, so patience is important. Your doctor will likely recommend follow-up bone density scans at 12-24 month intervals to monitor your progress and determine if continued treatment is beneficial.

Want to Apply This Research?

  • Track your bone density scan results (measured as T-scores or percentage changes) at baseline and every 12 months. Record the specific sites measured: lumbar spine, femoral neck, and total hip. Also log any bone-related medications you’re taking and any falls or bone-related symptoms to monitor real-world fracture risk reduction.
  • Use the app to set reminders for your monthly romosozumab injections (the medication is typically given monthly). Track adherence to treatment and correlate it with your bone density improvements. Log any side effects or concerns to discuss with your doctor at follow-up appointments.
  • Create a long-term tracking dashboard showing your bone density trends over time at each skeletal site. Set annual reminders for bone density scans. Monitor and log relevant blood test results (phosphate, PTH, alkaline phosphatase, vitamin D, calcium) to see if they correlate with your bone density improvements, similar to what researchers found in this study.

This research summary is for educational purposes only and should not replace professional medical advice. Romosozumab is a prescription medication that requires medical supervision. If you have osteoporosis or are at risk for bone fractures, consult with your healthcare provider to determine if romosozumab is appropriate for you. Your doctor will consider your individual health status, medical history, other medications, and blood test results before recommending treatment. This study involved 58 women in Spain and may not apply to all populations. Do not start, stop, or change any osteoporosis medication without consulting your doctor first.