Risk for fractures and fracture prevention among prostate cancer patients

An interesting new paper in BJU International has provided us with a somewhat different perspective on which patients with prostate cancer do and do not need preventive therapy (e.g., zoledronic acid/Zometa, dasatinib/Xgeva) to minimize risk for bone fractures. … READ MORE …

ADT and incidence of bone fractures on in the “real world”

Recent data from the Prostate Cancer Outcomes Study, which followed men diagnosed with prostate cancer for a total of 15 years after their diagnosis, have provided us with valuable information about risk for bone fractures in men with progressive disease. … READ MORE …

FDA expands approval of denosumab in men with advanced prostate cancer

According to a media release issued by Amgen earlier today, the U.S. Food & Drug Administration (FDA) has approved denosumab (marketed as both Prolia® and Xgeva®) as a treatment to increase bone mass in in men with non-metastatic prostate cancer who are already being treated with androgen deprivation therapy (ADT) and who are at high risk for bone fractures. … READ MORE …

Bisphosphonates in management of osteoporosis: an FDA update

Last Friday a U.S. Food & Drug Administration (FDA) advisory committee recommended (based on a 17 to 6 vote) that the labeling of bisphosphonates needed to be updated to make it clear how long patients should take these drugs to gain the greatest benefit and suffer the least risk. … READ MORE …

Bone mineral density and other risk factors for fractures in men on ADT

Clinical guidelines issued by the National Comprehensive Cancer Network recommend that prostate cancer patients being treated with androgen deprivation therapy (ADT) — either alone or in combination with radiation therapy — should be screened for osteoporosis and treatment to prevent deterioration of bone health associated with a decline in bone mineral density. … READ MORE …

Risk factors for vertebral fractures among men on ADT

White race and low bone mineral density (osteoporosis) appear to be the only two of a dozen different potential risk factors that significantly increase the likelihood of vertebral (spinal and hip) fractures among men being treated with androgen deprivation therapy (ADT) for prostate cancer. … READ MORE …

US FDA approves Xgeva for prevention of “skeletal-related events”

According to a media release from Amgen, issued late yesterday, the US Food & Drug Administration (FDA) has approved denosumab (to be known by the brand name Xgeva™) for “prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors.” This indication would include patients with prostate cancer and evident bone metastasis. … READ MORE …

Full report on the toremifene Phase III fracture prevention trial

Toremifene is a selective estrogen receptor modulator or SERM. Some time ago, its developer (GTx, Inc.) initiated a Phase III clinical trial to investigate whether toremifene at a dose of 80 mg/day lowered risk for new vertebral fractures in prostate cancer patients being treated with androgen deprivation therapy (ADT). … READ MORE …

Amgen’s Prolia approved in the USA but …

On Tuesday, the US Food and Drug Administration (FDA) approved Amgen’s RANK-L inhibitor denosumab (Prolia®) for the treatment of postmenopausal women with osteoporosis at high risk for fracture. However, what they have not done (yet) … READ MORE …