Study CR9108963: A 12-month, Randomized, Double-blind, Parallel-group, Placebo and Active-controlled Dose-range Finding Study of the Efficacy and Safety of SB-751689 in Post-menopausal Women With Osteoporosis

Percent Change From Baseline in Bone Marrow Density (BMD) at Month 12 Measured by Dual-Energy X-Ray Absorptiometry (DXA) Scans of the Lumbar Spine (L1-L4)

时间窗: Baseline (Day 0) and 12 Months

DXA scanners from Hologic and GE Lunar was used to measure BMD by a DXA scan. At least two vertebrae (L1-L4) that were suitable for measurement of BMD were evaluated. The same scanner was used throughout the study for all measurements for a given participant. DXA scans were sent to a central reading facility for quality control and central analysis. Assessments performed on Day 0 were considered as Baseline. Percent change from Baseline was computed as (change from baseline / baseline value) \* 100%. Percent change from Baseline in areal bone mineral density (aBMD) was reported.

Number of Participants Withdrew Due to Hypercalcemia

时间窗: Up to Month 12

A confirmed albumin-adjusted serum calcium pre-dose value of \>11.0 mg/dL or post-dose value of \>12.0 mg/dL was set as a withdrawal criteria for the study. Number of participants who met this pre-defined stopping criteria were reported.

Number of Participants With Hypercalcemia

时间窗: Up to Month 12

Participants with albumin-adjusted serum calcium pre-dose values of \>11.0 mg/ deciliter (dL) or post-dose values of \>12.0 mg/dL were recorded as participants with hypercalcemia. Number of participant with hypercalcemia were reported.

Number of Participant With Vital Signs of Potential Clinical Concern at Any Post-baseline Visit

时间窗: Up to 12 Months

The potential clinical importance ranges (low and high) of the vital sign parameters-systolic blood pressure (\> 30 millimeter of mercury \[mmHg\] decrease from Baseline, \> 30 mmHg increase from Baseline), diastolic blood pressure (\> 20 mmHg decrease from Baseline and \> 20 mmHg increase from Baseline) and heart rate (\<45 and \>120 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.

Number of Participant With Laboratory Abnormalities of Potential Clinical Concern at Any Post-baseline Visit

时间窗: Up to Month 12

The hematology parameters analyzed were white blood cells (WBC) count with differential WBC count, red blood cells, haemoglobin, haematocrit, mean corpuscular volume and platelet count. The clinical chemistry parameters analyzed were sodium, potassium, calcium, calcium (albumin adjusted), phosphate, bicarbonate, creatinine, bilirubin (total), alanine amino transferase, aspartate amino transferase, glucose, albumin, alkaline phosphatase, creatine phosphokinase, urea, uric acid, total protein, 25-OH vitamin D, 1,25-2(OH) vitamin D, whole parathyroid hormone (PTH 1-84)) and intact PTH (1-84 and 7-84). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important laboratory findings at any visit were reported.

Mean Change From Baseline in Height

时间窗: Baseline (Day 0), Month 6, 12 and early withdrawal

Assessments performed on Day 0 were considered as Baseline. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in height at Month 6 and 12 and early withdrawal were reported.

Mean Change From Baseline in Weight

时间窗: Baseline (Day 0), Month 6, 12 and early withdrawal

Baseline values were assessed on Day 0. Change from Baseline was computed as values at post baseline visit minus Baseline value. Mean change from baseline in weight at Month 6, 12 and early withdrawal were reported.

Number of Participant With Electrocardiogram (ECG) Findings Reported as Adverse Event

时间窗: Up to 12 months

Full 12-lead ECGs pre-dose at screening and visits 6, 8, 11, 12 and 14 were recorded. Participants rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. The central reviewer measured the following parameters and provide a clinical interpretation: heart rate, RR interval, PR interval, QRS interval, QT (uncorrected) interval, QTcB (Bazett's correction) interval, QTcF (Fridericia's correction) interval. The central reviewer was provided the investigator or designated qualified site physician with a central ECG report or confirmatory report to assist them in identifying any clinically significant abnormalities that would preclude the participant from further participation in the study.