Researchers studied a new medicine called romosozumab that helps strengthen bones in people with osteoporosis (weak bones). They looked at 146 patients, some with kidney disease and some without, to see if the medicine worked better alone or when combined with another vitamin D medicine called eldecalcitol. After 12 months, the medicine successfully increased bone density in the lower spine for everyone. Interestingly, when patients with kidney disease took both medicines together, they saw even better results. This suggests that combining these two treatments might be especially helpful for people dealing with both weak bones and kidney problems.

The Quick Take

  • What they studied: Whether a bone-strengthening drug called romosozumab works well for people with weak bones, and whether adding another medicine (eldecalcitol) makes it work better, especially for people with kidney disease.
  • Who participated: 146 patients with osteoporosis (weak bones). About 64 had chronic kidney disease, and 82 had normal kidney function. Some patients in each group received one medicine, while others received both medicines combined.
  • Key finding: The bone-strengthening medicine successfully increased bone density in the lower spine for all patients after one year. For patients with kidney disease who took both medicines together, the improvement was even greater than those taking just one medicine.
  • What it means for you: If you have weak bones and kidney disease, this research suggests that combining these two medicines might help your bones get stronger more effectively. However, talk to your doctor before making any changes to your treatment, as this is one study and more research is needed.

The Research Details

This was a real-world retrospective study, meaning researchers looked back at medical records of patients who had already received treatment rather than conducting a new experiment. They examined 146 patients with osteoporosis who received romosozumab treatment over 12 months. The patients were divided into two main groups based on their kidney function: those with chronic kidney disease (64 patients) and those with normal kidney function (82 patients). Within each group, some patients received only romosozumab, while others received romosozumab combined with eldecalcitol, a form of vitamin D. The researchers measured bone density in two important locations: the lower spine and the hip bone (femoral neck) at the beginning and end of the 12-month period. They also measured certain blood markers that indicate how quickly bones are being broken down and rebuilt.

This study design is important because it shows how these medicines work in real patients in actual medical practice, not just in controlled laboratory settings. By comparing patients with and without kidney disease, the researchers could determine whether kidney problems change how well these bone-strengthening medicines work. This helps doctors understand which patients might benefit most from combination therapy.

This study has some strengths: it included a reasonable number of patients (146) and tracked them for a full year, which is long enough to see meaningful changes in bone density. However, because it looked at past medical records rather than following new patients forward, there’s a limit to what conclusions can be drawn. The study was conducted in a real medical setting, which makes the results more applicable to everyday patients. The researchers measured objective outcomes like bone density, which are reliable measures. Readers should note that this is one study, and the findings would be stronger if confirmed by additional research.

What the Results Show

After 12 months of treatment, bone density in the lower spine increased significantly in both groups of patients—those with kidney disease and those without. This means the medicine successfully helped strengthen bones in this important area for both groups. However, bone density in the hip area (femoral neck) did not show significant improvement in either group, suggesting the medicine works better in some parts of the skeleton than others. The amount of improvement in the lower spine was similar between patients with and without kidney disease, indicating that kidney problems didn’t prevent the medicine from working. When patients with kidney disease took both medicines together (romosozumab plus eldecalcitol), they showed greater improvements in hip bone density and better changes in blood markers that indicate bone health compared to those taking only romosozumab.

Blood tests measuring bone turnover markers (specifically procollagen type I N-terminal propeptide) showed greater improvements in patients with kidney disease who received the combination treatment compared to those receiving single-drug therapy. This suggests the combination may help regulate how quickly bones are broken down and rebuilt, which is an important aspect of bone health. The combination treatment appeared to be well-tolerated, with no unexpected safety concerns reported during the study period.

Previous research on romosozumab in patients without kidney disease has shown it effectively increases bone density. This study extends that knowledge by demonstrating the medicine also works in patients with kidney disease, which is important because kidney disease can complicate bone health. The finding that combination therapy may be superior for kidney disease patients is relatively new and suggests a potential advancement in treatment options for this specific population.

This study looked backward at existing medical records rather than following patients forward in a controlled way, which limits how certain we can be about cause and effect. The number of patients receiving combination therapy was relatively small (15 with kidney disease, 18 without), so the findings about combination treatment need confirmation in larger studies. The study didn’t include a control group that received no treatment, so we can’t compare results to untreated patients. The study was conducted in one healthcare system, so results might differ in other populations or settings. The researchers didn’t report on side effects in detail, so more information about safety would be helpful.

The Bottom Line

Based on this research, romosozumab appears to be an effective treatment for osteoporosis in both people with normal kidney function and those with kidney disease (moderate confidence level). For patients with kidney disease specifically, combining romosozumab with eldecalcitol may provide additional benefits compared to romosozumab alone (lower confidence level, as this finding needs confirmation). These recommendations should only be considered in consultation with your doctor, who can evaluate your individual situation.

This research is most relevant for people diagnosed with osteoporosis who are considering treatment options, particularly those who also have chronic kidney disease. People with normal kidney function may also benefit from this information, though the findings are somewhat less specific to their situation. Healthcare providers treating osteoporosis patients, especially those with kidney disease, should be aware of these findings. People at risk for osteoporosis but not yet diagnosed should focus on prevention strategies rather than these medications.

Based on this study, meaningful improvements in bone density in the lower spine can be expected within 12 months of starting treatment. However, improvements in hip bone density may take longer or may not occur significantly with this medicine alone. Individual results will vary, and some people may see benefits sooner while others take longer. Consistent treatment over the full 12-month period appears necessary to achieve the results shown in this study.

Want to Apply This Research?

  • Track bone density test results (DEXA scan measurements) every 6-12 months, recording specific values for lumbar spine and femoral neck. Also monitor any bone pain or fracture incidents, and note any side effects experienced from medications.
  • Set monthly reminders to take prescribed medications consistently, log weekly calcium and vitamin D intake through food or supplements, and schedule regular check-ins with your healthcare provider to monitor kidney function and treatment response.
  • Create a long-term health dashboard tracking: (1) scheduled bone density test dates and results, (2) kidney function tests (eGFR values), (3) medication adherence rates, (4) any new fractures or bone-related symptoms, and (5) blood work markers related to bone turnover. Review progress quarterly with your healthcare provider.

This research summary is for educational purposes only and should not be used as a substitute for professional medical advice. Romosozumab and eldecalcitol are prescription medications that require medical supervision. If you have osteoporosis, chronic kidney disease, or both, consult with your healthcare provider before starting, stopping, or changing any treatment. Your doctor can evaluate your individual health status, kidney function, and other medications to determine the most appropriate treatment plan for you. This study represents one research finding; treatment decisions should be based on comprehensive medical evaluation and discussion with your healthcare team.