Denosumab in Men Receiving Androgen-Deprivation Therapy for Prostate Cancer
- Study type
- Clinical trial
- Study name
- HALT 138
- Design
- Randomised, double-blind, multicentre, placebo-controlled study
- Sample size
- 1468 patients (734 in each group)
- Source
- N Engl J Med · 2009
- Trial registration
- NCT00089674
In plain words
Hormone treatment (androgen deprivation) for prostate cancer can weaken the bones and increase the risk of fractures. In this study, an injection of denosumab under the skin every 6 months increased bone strength (density) compared with a placebo. New fractures of the spine were also less common in the denosumab group (1.5% versus 3.9%). Side effects were similar in the two groups.
Key results
Treatment arms and regimens
Denosumab 60 mg subcutaneously (1 mL injection) every 6 months for 36 months, with daily supplements of calcium at least 1 g and vitamin D at least 400 IU (734 patients).
Subcutaneous placebo every 6 months with the same calcium and vitamin D supplements (734 patients).
Source of the regimen details: Full text of the paper (PMC3038121)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
1468 men with non-metastatic prostate cancer receiving ADT (bilateral orchiectomy or a GnRH agonist) with an expected duration of at least 12 months, who were aged 70 years or older, or under 70 years with low bone mineral density (T-score below −1.0 at the lumbar spine, total hip or femoral neck) or a history of osteoporotic fracture. Concurrent anticancer therapy or radiotherapy and current oral bisphosphonate use were exclusion criteria.
Endpoints
Primary endpoint: percentage change in lumbar spine bone mineral density (BMD) at month 24.
Key secondary endpoints: percentage change in bone mineral density at the femoral neck and total hip at month 24 and at all three sites at month 36, and the incidence of new vertebral fractures.
Safety and side effects
The overall adverse event rate was about 87% in both groups; serious adverse events 34.6% versus 30.6%; discontinuation because of an adverse event 6.7% versus 6.5%; one case of hypocalcaemia (0.1%) with denosumab.
Clinical significance and place in guidelines
This study shows that denosumab can be useful for preserving bone health and reducing vertebral fractures in men receiving androgen-deprivation therapy for non-metastatic prostate cancer. The status of drug approvals and clinical guideline recommendations should be checked separately, as the abstract does not mention them.
Limitations
The abstract does not mention the limitations of the study. Details of specific adverse events and their grading should be checked in the full text of the paper.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.