Statement: Both cohorts of the primary trial in a negative (mean) Percent Change From Baseline of Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr).
Primary_evidence: Outcome Measurement:    Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)   Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.   Time frame: Baseline and Week 13 Results 1:    Arm/Group Title: Bisphosphonate IV Q4W   Arm/Group Description: Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion   Overall Number of Participants Analyzed: 38   Mean (Standard Deviation)   Unit of Measure: Percent change  -10.19         (208.84) Results 2:    Arm/Group Title: Denosumab 30 mg Q4W   Arm/Group Description: Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)   Overall Number of Participants Analyzed: 40   Mean (Standard Deviation)   Unit of Measure: Percent change  -52.87         (95.14)