Mode
Text Size
Log in / Sign up

Denosumab showed no effect on periprosthetic bone density five years after uncemented total hip arthroplastyDenosumab showed no benefit for bone density five years after hip replacement surgery

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway
Note that denosumab showed no significant effect on periprosthetic bone density five years after uncemented total hip arthroplasty.

This study represents a secondary exploratory analysis of a previously published phase-2 randomized controlled trial. The population consisted of 54 non-osteoporotic patients who underwent uncemented total hip arthroplasty, with a mean follow-up of 5.6 years (range 4.3 to 7.3 years). The intervention involved two doses of denosumab, compared against a placebo control group.

At 12 months, the primary outcome assessed periprosthetic bone mineral density (pBMD). By the 5-year follow-up, the sum of pBMD in acetabular Digas zones showed an estimated mean difference of 0.042 g/cm² (95% CI -0.31 to 0.35; P = 0.8) between groups. Similarly, the sum of pBMD in femoral Gruen zones demonstrated an estimated mean difference of -0.06 g/cm² (95% CI -0.55 to 0.43; P = 0.8). No statistically significant differences were observed for patient-reported outcome measures or the incidence of heterotopic ossification.

A gradual decline in periprosthetic bone mineral density was evident over the follow-up period for both groups. Safety data, including adverse events, serious adverse events, discontinuations, and tolerability, were not reported in this analysis. The study authors noted that whether longer treatment duration or a sequential post-denosumab regimen could influence long-term bone preservation remains unknown.

The adjusted between-group difference and its 95% confidence interval indicated no statistically or clinically relevant effect of denosumab on periprosthetic bone density at five years. Given the exploratory nature of this analysis and the absence of significant findings, current evidence does not support the use of denosumab for long-term periprosthetic bone preservation in this population.

Researchers looked at data from a previous trial involving 54 patients who received uncemented hip replacements. These patients were originally enrolled in a study testing two doses of denosumab compared to a placebo. The team analyzed bone density around the hip joint and other health measures at an average of 5.6 years after surgery.

The results showed no statistically significant difference between the drug group and the placebo group. Bone density in both the hip cup and the thigh bone declined gradually over time for everyone, regardless of treatment. Patients also reported similar levels of pain and function, and the rate of abnormal bone growth was the same in both groups.

Because this is a secondary analysis of a Phase 2 trial, the findings are limited. The study was not designed to answer questions about long-term bone preservation or clinical outcomes like the need for revision surgery. Readers should understand that this does not prove the drug is ineffective for all patients, but it shows no clear benefit for this specific group over five years.

What this means for you:
This study found no benefit of denosumab for bone density five years after hip replacement in patients without osteoporosis.

Study Details

Study typeRct
Sample sizen = 54
EvidenceLevel 2
Follow-up60.0 mo
PublishedApr 2026
View Original Abstract ↓
BACKGROUND AND PURPOSE:  Denosumab may preserve periprosthetic bone mineral density (pBMD) around uncemented total hip arthroplasty (THA) components. This exploratory analysis of a previously published randomized controlled trial (RCT) aimed to assess the effects of denosumab on BMD 5 years after treatment cessation. METHODS:  64 non-osteoporotic patients undergoing uncemented THA were enrolled in a randomized, double-blind, placebo-controlled phase-2 trial and received either 2 doses of denosumab or placebo. The primary outcome was pBMD at 12 months, measured by dual-energy X-ray absorptiometry (DEXA). At a mean follow-up of 5.6 years (range 4.3-7.3), 54 patients remained for clinical assessment, DEXA, and plain radiography. The study was registered on ClinicalTrials.gov (NCT01630941). RESULTS:  No differences in pBMD in the acetabular Digas zones or femoral Gruen zones were found between the groups at 5 years. The estimated mean difference in the sum of all zones around the cup was 0.042 g/cm² (95% confidence interval [CI] -0.31 to 0.35; P = 0.8), and for the sum of all Gruen zones -0.06 g/cm² (CI -0.55 to 0.43; P = 0.8). No statistically significant differences were observed in patient-reported outcome measures or the incidence of heterotopic ossification. A gradual decline in pBMD was evident. CONCLUSION:  At 5 years, the adjusted between-group difference and its 95% confidence interval showed no statistically or clinically relevant effect of denosumab. Whether longer treatment duration or a sequential post-denosumab regimen could influence long-term periprosthetic bone preservation is unknown.
Free Newsletter

Clinical research that matters. Delivered to your inbox.

Join thousands of clinicians and researchers. No spam, unsubscribe anytime.