. Author manuscript; available in PMC: 2014 Feb 1.

Published in final edited form as: Cancer Treat Rev. 2012 Aug 13;39(1):97–104. doi: 10.1016/j.ctrv.2012.07.002

Table 1.

Characteristics of the Included Studies.

Study	Follow-up (Months)	Population	Treated previously with IV Bisphosphonates	Mean age (yrs)	Intervention	Control	Outcomes
PHASE II TRIALS
Body 2006³²	2.8	Myeloma Breast cancer	No	60.5 55.5	DB SQ 0.1,0.3,1.0,3.0 mg/kg (one dose)	Pamidronate IV 90mg (one dose)	BTM
Lipton 2007^28, ⁴²	3	Breast cancer	No	58.7	DB SQ 30,120,180 mg Q 4W 60, 180 mg Q 12W	Bisphosphonates IV Q 4W	Incidence of SRE BTM Safety
Fizazi 2009^{33, 42,} ⁶⁰	3	Prostate Breast Solid tumors (except lung) and uNTX > 50nM BCE/mM	Yes	60.5	DB SQ 180 mg Q 4W or Q 12W	Bisphosphonates IV Q 4W	Incidence of SRE BTM Safety

PHASE III TRIALS

Stopeck 2010^34, ^{38, 41}	34	Breast cancer	No	56.0	DB SQ 120 mg Q 4W	ZA IV 4 mg Q 4W	Incidence of SRE. Time to first on-study SRE Time to first and subsequent on-study SRE Overall survival Overall disease progression Pain, HRQL BTM Safety
Fizazi 2011^{35, 40}	41	Castrate resistant prostate cancer	No	71.0	DB SQ 120 mg Q 4W	ZA IV 4 mg Q 4W	Incidence of SRE Time to first on-study SRE Time to first and subsequent on-study SRE Overall survival Overall disease progression Pain BTM Safety
Henry 2011^{36, 39}	34	Solid tumors (except breast and prostate) Myeloma	No	60.5	DB SQ 120 mg 4W	ZA IV 4 mg Q 4W	Incidence of SRE Time to first on-study SRE Time to first and subsequent on-study SRE Overall survival Overall disease progression Pain BTM Safety

Q 4 W,12W, every 4 weeks and 12 weeks, DB, denosumab; ZA, zoledronic acid; BP, bisphosphonates; SQ, subcutaneous; IV, intravenous; uNTX, urine N-telopeptide; SRE, skeletal-related events.