Observational studyProstate cancer

Risk of Fracture after Androgen Deprivation for Prostate Cancer

N Engl J Med · 200550,613 men
Shahinian VB, Kuo YF, Freeman JL, Goodwin JS. N Engl J Med. 2005. 352:154-164
Study type
Observational study
Design
Cohort study based on the linked SEER and Medicare database
Sample size
50,613 men
Source
N Engl J Med · 2005

In plain words

Hormone treatment that lowers male hormones in prostate cancer can weaken the bones. In this large study, men who lived at least five years after diagnosis and had this treatment had more fractures (19.4% versus 12.6%). The more doses of a gonadotropin-releasing hormone drug a man had received, the higher his risk of fracture. Talk to your doctor about your bone health.

Key results

19.4% in the ADT group vs 12.6% in the group without ADT
Fracture in men surviving at least five years after diagnosis
P<0.001
Statistically significant association in the adjusted Cox analyses
Association between the number of doses of gonadotropin-releasing hormone in the 12 months after diagnosis and the risk of later fracture
Adjusted for patient and tumour characteristics

Treatment arms and regimens

1Recipients of androgen deprivation therapy (ADT)

Men with prostate cancer who received androgen deprivation therapy; fracture risk was associated with the number of doses of GnRH agonist received in the 12 months after diagnosis (observational study; there is no fixed drug regimen).

2No androgen deprivation therapy

Men with prostate cancer who did not receive androgen deprivation therapy.

Source of the regimen details: Abstract of the paper (observational study; no drug regimen)

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

Men recorded in the linked Surveillance, Epidemiology, and End Results (SEER) programme and Medicare database with a diagnosis of prostate cancer between 1992 and 1997.

Endpoints

Main endpoints: occurrence of any fracture and occurrence of a fracture requiring hospitalisation. Cox proportional hazards analyses were adjusted for patient and cancer characteristics, other cancer treatments, and the occurrence of a fracture or a diagnosis of osteoporosis in the 12 months before the cancer diagnosis.

Safety and side effects

This observational study focused on fracture risk as the main outcome; no other adverse-event data are reported in the abstract.

Clinical significance and place in guidelines

This study showed that androgen deprivation therapy increases the risk of fracture, and that fracture risk should be taken into account when deciding on this treatment. Specific recommendations on screening for and preventing skeletal complications should be checked in current clinical guidelines, as the abstract gives no information on them.

Limitations

This research is observational and based on administrative data, so bias and residual confounding are possible, although the analyses were adjusted for several factors. Further details 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.