NCT00896532

Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

Completed Phase 2 Results posted Last updated 22 September 2022

What this trial tests

Phase 2 trial testing Placebo to Romosozumab in Low Bone Mineral Density in 419 participants. Completed in 18 February 2016.

Timeline

3 June 2009

Primary endpoint
21 February 2011

18 February 2016

Quick facts

Lead sponsor	Amgen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	419
Start date	3 June 2009
Primary completion	21 February 2011
Estimated completion	18 February 2016

Drugs / interventions tested

• Placebo to Romosozumab — full drug profile →
• Alendronate — full drug profile →
• Teriparatide
• Romosozumab (romosozumab) — full drug profile →
• Denosumab (DENOSUMAB) — full drug profile →
• Placebo to Denosumab
• Zoledronic acid (ZOLEDRONIC ACID) — full drug profile →

Conditions studied

• Low Bone Mineral Density — all drugs for Low Bone Mineral Density →
• Postmenopausal Osteoporosis — all drugs for Postmenopausal Osteoporosis →

Sponsor

Amgen — full company profile →

Who can join

Adults 55 to 85, female only, with Low Bone Mineral Density or Postmenopausal Osteoporosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine Primary · Baseline to 12 months

Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.

Group	Value	95% CI
Placebo	-0.1	-1.2 – 0.9
Alendronate	4.1	3.0 – 5.1
Teriparatide	7.1	6.1 – 8.2
Romosozumab 70 mg QM	5.4	4.3 – 6.4
Romosozumab 140 mg Q3M	5.4	4.4 – 6.5
Romosozumab 140 mg QM	9.1	8.0 – 10.2
Romosozumab 210 mg Q3M	5.5	4.4 – 6.6
Romosozumab 210 mg QM	11.3	10.3 – 12.4
Romosozumab Monthly	8.6	7.9 – 9.3
Romosozumab Every 3 Months	5.5	4.7 – 6.3
Romosozumab 140 mg	7.3	6.4 – 8.1
Romosozumab 210 mg	8.4	7.6 – 9.2

Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine Secondary · Baseline to 6 months

Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.

Group	Value	95% CI
Placebo	0.3	-0.7 – 1.3
Alendronate	2.6	1.6 – 3.6
Teriparatide	4.8	3.8 – 5.8
Romosozumab 70 mg QM	4.1	3.1 – 5.1
Romosozumab 140 mg Q3M	4.2	3.2 – 5.2
Romosozumab 140 mg QM	7.1	6.1 – 8.1
Romosozumab 210 mg Q3M	4.4	3.4 – 5.3
Romosozumab 210 mg QM	8.2	7.3 – 9.2

Percent Change From Baseline at Month 6 in BMD of the Total Hip Secondary · Baseline to 6 months

Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.

Group	Value	95% CI
Placebo	-0.6	-1.2 – -0.1
Alendronate	0.9	0.3 – 1.5
Teriparatide	0.5	-0.0 – 1.1
Romosozumab 70 mg QM	0.5	-0.1 – 1.1
Romosozumab 140 mg Q3M	0.9	0.3 – 1.5
Romosozumab 140 mg QM	2.2	1.7 – 2.8
Romosozumab 210 mg Q3M	1.1	0.6 – 1.7
Romosozumab 210 mg QM	2.9	2.3 – 3.4

Percent Change From Baseline at Month 6 in BMD of the Femoral Neck Secondary · Baseline to 6 months

Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to month 6 was analyzed using a linear mixed effects model with the percent change from baseline to month 6 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.

Group	Value	95% CI
Placebo	-0.4	-1.3 – 0.4
Alendronate	0.5	-0.3 – 1.4
Teriparatide	0.5	-0.3 – 1.3
Romosozumab 70 mg QM	0.2	-0.7 – 1.1
Romosozumab 140 mg Q3M	0.4	-0.4 – 1.3
Romosozumab 140 mg QM	2.1	1.3 – 3.0
Romosozumab 210 mg Q3M	0.9	0.1 – 1.7
Romosozumab 210 mg QM	1.9	1.0 – 2.7

Percent Change From Baseline at Month 12 in BMD of the Total Hip Secondary · Baseline to 12 months

Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.

Group	Value	95% CI
Placebo	-0.7	-1.4 – -0.1
Alendronate	1.9	1.3 – 2.6
Teriparatide	1.3	0.7 – 2.0
Romosozumab 70 mg QM	1.3	0.6 – 2.0
Romosozumab 140 mg Q3M	1.3	0.7 – 2.0
Romosozumab 140 mg QM	3.4	2.7 – 4.1
Romosozumab 210 mg Q3M	1.9	1.3 – 2.6
Romosozumab 210 mg QM	4.1	3.5 – 4.8

Percent Change From Baseline at Month 12 in BMD of the Femoral Neck Secondary · Baseline to 12 months

Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline to 12 months in BMD was analyzed using a linear mixed effects model with the percent change from baseline to month 12 in DXA BMD as dependent variable, and baseline BMD value, machine type, geographic region, interaction of baseline BMD and machine type, visit, treatment (categorical) and interaction of treatment and visit as the independent variables.

Group	Value	95% CI
Placebo	-1.1	-2.0 – -0.2
Alendronate	1.2	0.3 – 2.1
Teriparatide	1.1	0.2 – 2.0
Romosozumab 70 mg QM	0.6	-0.3 – 1.6
Romosozumab 140 mg Q3M	1.8	0.9 – 2.7
Romosozumab 140 mg QM	4.2	3.3 – 5.1
Romosozumab 210 mg Q3M	1.4	0.5 – 2.3
Romosozumab 210 mg QM	3.7	2.8 – 4.6

Percent Change From Baseline at Month 12 in BMD of the Distal Radius Secondary · Baseline to 12 months

Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader. Percent change from baseline in distal radius BMD was analyzed using an analysis of covariance (ANCOVA) model with the percent change from baseline to Month 12 in DXA BMD as dependent variable, baseline BMD value, machine type, interaction of baseline BMD and machine type, treatment (categorical) and geographic region as the independent class variables.

Group	Value	95% CI
Placebo	-0.9	-1.8 – 0.1
Alendronate	-0.3	-1.2 – 0.7
Teriparatide	-1.7	-2.7 – -0.7
Romosozumab 70 mg QM	-1.8	-2.8 – -0.8
Romosozumab 140 mg Q3M	-1.1	-2.1 – -0.2
Romosozumab 140 mg QM	-1.0	-2.0 – -0.0
Romosozumab 210 mg Q3M	-0.4	-1.3 – 0.5
Romosozumab 210 mg QM	-1.2	-2.1 – -0.2

Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) Secondary · Baseline and months 1, 3, 6, 9, and 12

Percent change from baseline in the bone turnover marker (BTM) P1NP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.

Month 1

Group	Value	95% CI
Placebo	-0.7	-8.7 – 8.1
Romosozumab 70 mg QM	24.2	14.1 – 35.3
Romosozumab 140 mg Q3M	61.4	48.6 – 75.3
Romosozumab 140 mg QM	55.0	42.2 – 69.0
Romosozumab 210 mg Q3M	75.8	61.8 – 90.9
Romosozumab 210 mg QM	92.2	76.6 – 109.1

Month 3

Group	Value	95% CI
Placebo	-5.4	-13.6 – 3.6
Alendronate	-50.8	-55.1 – -46.2
Teriparatide	97.1	79.7 – 116.1
Romosozumab 70 mg QM	-9.1	-17.1 – -0.2
Romosozumab 140 mg Q3M	-15.5	-22.7 – -7.7
Romosozumab 140 mg QM	3.8	-5.4 – 13.9
Romosozumab 210 mg Q3M	-19.5	-26.4 – -12.1
Romosozumab 210 mg QM	25.6	14.6 – 37.5

Month 6

Group	Value	95% CI
Placebo	-5.9	-14.6 – 3.6
Alendronate	-57.0	-61.0 – -52.7
Teriparatide	138.0	115.7 – 162.6
Romosozumab 70 mg QM	-20.0	-27.7 – -11.4
Romosozumab 140 mg Q3M	-22.8	-29.9 – -15.0
Romosozumab 140 mg QM	-18.6	-26.3 – -10.1
Romosozumab 210 mg Q3M	-25.5	-32.2 – -18.1
Romosozumab 210 mg QM	6.9	-3.0 – 17.8

Month 9

Group	Value	95% CI
Placebo	-10.6	-19.6 – -0.7
Alendronate	-60.8	-64.7 – -56.5
Teriparatide	116.8	95.1 – 140.9
Romosozumab 70 mg QM	-26.9	-34.4 – -18.5
Romosozumab 140 mg Q3M	-23.8	-31.4 – -15.4
Romosozumab 140 mg QM	-26.1	-33.6 – -17.8
Romosozumab 210 mg Q3M	-30.1	-36.8 – -22.6
Romosozumab 210 mg QM	-5.8	-15.1 – 4.6

Month 12

Group	Value	95% CI
Placebo	-8.7	-17.9 – 1.5
Alendronate	-60.8	-64.7 – -56.4
Teriparatide	98.3	78.3 – 120.5
Romosozumab 70 mg QM	-23.0	-31.0 – -14.0
Romosozumab 140 mg Q3M	-23.3	-30.9 – -14.9
Romosozumab 140 mg QM	-31.2	-38.2 – -23.4
Romosozumab 210 mg Q3M	-29.7	-36.7 – -22.1
Romosozumab 210 mg QM	-17.2	-25.4 – -8.1

Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX) Secondary · Baseline and months 1, 3, 6, 9, and 12

Percent change from baseline in the bone turnover marker (BTM) CTX was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.

Month 1

Group	Value	95% CI
Placebo	-3.9	-12.1 – 5.1
Romosozumab 70 mg QM	-22.1	-28.9 – -14.7
Romosozumab 140 mg Q3M	-19.2	-26.0 – -11.7
Romosozumab 140 mg QM	-35.4	-41.0 – -29.2
Romosozumab 210 mg Q3M	-33.0	-38.6 – -26.8
Romosozumab 210 mg QM	-28.5	-34.7 – -21.8

Month 3

Group	Value	95% CI
Placebo	-2.4	-12.0 – 8.2
Alendronate	-65.0	-68.5 – -61.1
Teriparatide	69.4	52.6 – 88.0
Romosozumab 70 mg QM	-21.5	-29.3 – -12.8
Romosozumab 140 mg Q3M	-6.2	-15.2 – 3.8
Romosozumab 140 mg QM	-26.5	-33.8 – -18.3
Romosozumab 210 mg Q3M	-12.6	-21.0 – -3.4
Romosozumab 210 mg QM	-3.7	-13.2 – 6.7

Month 6

Group	Value	95% CI
Placebo	2.7	-8.4 – 15.2
Alendronate	-64.2	-68.1 – -59.8
Teriparatide	93.5	72.3 – 117.4
Romosozumab 70 mg QM	-18.1	-27.3 – -7.7
Romosozumab 140 mg Q3M	-8.4	-18.3 – 2.7
Romosozumab 140 mg QM	-24.6	-33.0 – -15.2
Romosozumab 210 mg Q3M	-10.5	-20.0 – 0.0
Romosozumab 210 mg QM	-8.7	-18.6 – 2.4

Month 9

Group	Value	95% CI
Placebo	1.0	-11.2 – 14.9
Alendronate	-64.4	-68.6 – -59.5
Teriparatide	81.3	59.4 – 106.2
Romosozumab 70 mg QM	-15.1	-25.7 – -3.0
Romosozumab 140 mg Q3M	1.3	-10.8 – 15.1
Romosozumab 140 mg QM	-27.7	-36.6 – -17.6
Romosozumab 210 mg Q3M	-11.7	-22.0 – -0.1
Romosozumab 210 mg QM	-17.2	-27.1 – -6.0

Month 12

Group	Value	95% CI
Placebo	9.8	-3.9 – 25.4
Alendronate	-66.7	-70.8 – -62.0
Teriparatide	77.0	54.9 – 102.1
Romosozumab 70 mg QM	-20.3	-30.6 – -8.6
Romosozumab 140 mg Q3M	12.2	-1.5 – 27.8
Romosozumab 140 mg QM	-33.0	-41.4 – -23.3
Romosozumab 210 mg Q3M	-6.6	-18.0 – 6.5
Romosozumab 210 mg QM	-22.5	-32.0 – -11.7

Percent Change From Baseline in Osteocalcin Secondary · Baseline and months 1, 3, 6, 9, and 12

Percent change from baseline in the bone turnover marker (BTM) osteocalcin was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.

Month 1

Group	Value	95% CI
Placebo	-1.6	-9.1 – 6.5
Romosozumab 70 mg QM	28.1	18.3 – 38.7
Romosozumab 140 mg Q3M	60.1	48.2 – 73.0
Romosozumab 140 mg QM	53.1	41.2 – 65.9
Romosozumab 210 mg Q3M	77.9	64.7 – 92.2
Romosozumab 210 mg QM	78.6	65.0 – 93.2

Month 3

Group	Value	95% CI
Placebo	4.1	-5.6 – 14.7
Alendronate	-28.7	-35.3 – -21.5
Teriparatide	104.7	85.5 – 125.9
Romosozumab 70 mg QM	-0.3	-9.8 – 10.1
Romosozumab 140 mg Q3M	-5.6	-14.2 – 3.8
Romosozumab 140 mg QM	15.6	4.7 – 27.7
Romosozumab 210 mg Q3M	-3.7	-12.5 – 5.9
Romosozumab 210 mg QM	41.6	28.4 – 56.1

Month 6

Group	Value	95% CI
Placebo	-7.1	-16.2 – 2.8
Alendronate	-40.6	-46.3 – -34.2
Teriparatide	106.7	86.5 – 129.1
Romosozumab 70 mg QM	-11.8	-20.8 – -1.8
Romosozumab 140 mg Q3M	-16.5	-24.5 – -7.6
Romosozumab 140 mg QM	-7.4	-16.5 – 2.8
Romosozumab 210 mg Q3M	-23.2	-30.5 – -15.3
Romosozumab 210 mg QM	10.0	-0.7 – 21.7

Month 9

Group	Value	95% CI
Placebo	-6.0	-15.0 – 4.0
Alendronate	-50.9	-55.6 – -45.8
Teriparatide	99.9	80.8 – 121.0
Romosozumab 70 mg QM	-26.9	-34.1 – -18.9
Romosozumab 140 mg Q3M	-29.0	-35.8 – -21.6
Romosozumab 140 mg QM	-27.7	-34.7 – -19.9
Romosozumab 210 mg Q3M	-30.7	-37.1 – -23.7
Romosozumab 210 mg QM	-4.0	-13.1 – 6.0

Month 12

Group	Value	95% CI
Placebo	-14.1	-22.0 – -5.4
Alendronate	-50.3	-54.8 – -45.4
Teriparatide	91.6	74.1 – 110.9
Romosozumab 70 mg QM	-27.3	-34.1 – -19.6
Romosozumab 140 mg Q3M	-24.7	-31.4 – -17.2
Romosozumab 140 mg QM	-31.1	-37.5 – -24.1
Romosozumab 210 mg Q3M	-26.2	-32.9 – -18.9
Romosozumab 210 mg QM	-12.5	-20.4 – -3.9

Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) Secondary · Baseline and months 1, 3, 6, 9, and 12

Percent change from baseline in the bone turnover marker (BTM) BSAP was analyzed using a linear mixed effects model with the natural logarithm of the ratio of BTM (follow-up versus baseline) as the dependent variables, and visit, treatment (categorical), interaction of treatment and visit and the natural logarithm of the baseline BTM as the independent variables; outcomes were then transformed back to percent change from baseline.

Month 1

Group	Value	95% CI
Placebo	-1.1	-6.7 – 4.9
Romosozumab 70 mg QM	11.7	5.2 – 18.5
Romosozumab 140 mg Q3M	35.1	27.5 – 43.1
Romosozumab 140 mg QM	29.3	21.8 – 37.3
Romosozumab 210 mg Q3M	47.5	39.3 – 56.2
Romosozumab 210 mg QM	60.9	51.7 – 70.7

Month 3

Group	Value	95% CI
Placebo	-7.6	-14.3 – -0.3
Alendronate	-30.5	-35.5 – -25.0
Teriparatide	21.8	12.8 – 31.4
Romosozumab 70 mg QM	-8.5	-15.3 – -1.1
Romosozumab 140 mg Q3M	-18.0	-23.9 – -11.7
Romosozumab 140 mg QM	1.3	-6.2 – 9.4
Romosozumab 210 mg Q3M	-17.3	-23.2 – -10.9
Romosozumab 210 mg QM	27.4	18.1 – 37.4

Month 6

Group	Value	95% CI
Placebo	-4.1	-12.1 – 4.5
Alendronate	-35.4	-40.8 – -29.7
Teriparatide	29.8	19.0 – 41.6
Romosozumab 70 mg QM	-8.7	-16.6 – -0.1
Romosozumab 140 mg Q3M	-18.2	-25.0 – -10.9
Romosozumab 140 mg QM	-6.6	-14.5 – 2.0
Romosozumab 210 mg Q3M	-20.0	-26.4 – -13.0
Romosozumab 210 mg QM	13.1	3.8 – 23.3

Month 9

Group	Value	95% CI
Placebo	3.5	-3.8 – 11.4
Alendronate	-32.5	-37.3 – -27.4
Teriparatide	41.8	31.7 – 52.6
Romosozumab 70 mg QM	-4.9	-11.9 – 2.6
Romosozumab 140 mg Q3M	-12.5	-18.7 – -5.9
Romosozumab 140 mg QM	-5.5	-12.3 – 1.8
Romosozumab 210 mg Q3M	-17.7	-23.3 – -11.7
Romosozumab 210 mg QM	10.4	2.7 – 18.8

Month 12

Group	Value	95% CI
Placebo	9.2	1.7 – 17.2
Alendronate	-31.2	-35.9 – -26.2
Teriparatide	45.7	35.7 – 56.4
Romosozumab 70 mg QM	-2.6	-9.5 – 4.8
Romosozumab 140 mg Q3M	-10.8	-16.9 – -4.4
Romosozumab 140 mg QM	-5.0	-11.6 – 2.1
Romosozumab 210 mg Q3M	-12.4	-18.3 – -6.1
Romosozumab 210 mg QM	9.2	1.8 – 17.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events are reported by treatment phase: Romosozumab treatment phase (Baseline [BL] to month 12 and 24); Denosumab extension phase (months 24 to 36); Romosozumab retreatment phase (months 36 to 48); Follow-on phase (months 48 to 72).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BL-Month 12: Placebo QM

Serious: 3/30 (10%)

Deaths: —

BL-Month 12: Placebo Q3M

Serious: 4/20 (20%)

Deaths: —

BL-Month 12: Alendronate

Serious: 4/51 (8%)

Deaths: —

BL-Month12: Teriparatide

Serious: 5/54 (9%)

Deaths: —

BL-Month 12: Romosozumab 70 mg QM

Serious: 5/50 (10%)

Deaths: —

BL-Month 12: Romosozumab 140 mg Q3M

Serious: 3/52 (6%)

Deaths: —

BL-Month 12: Romosozumab 140 mg QM

Serious: 2/49 (4%)

Deaths: —

BL-Month 12: Romosozumab 210 mg Q3M

Serious: 3/53 (6%)

Deaths: —

BL-Month 12: Romosozumab 210 mg QM

Serious: 6/51 (12%)

Deaths: —

BL-Month 24: Placebo QM

Serious: 5/30 (17%)

Deaths: —

BL-Month 24: Placebo Q3M

Serious: 4/20 (20%)

Deaths: —

BL-Month 24: ALN/Romosozumab 140 mg QM

Serious: 8/51 (16%)

Deaths: —

BL-Month 24: Romosozumab 70 mg QM

Serious: 9/50 (18%)

Deaths: —

BL-Month 24: Romosozumab 140 mg Q3M

Serious: 8/52 (15%)

Deaths: —

BL-Month 24: Romosozumab 140 mg QM

Serious: 8/49 (16%)

Deaths: —

BL-Month 24: Romosozumab 210 mg Q3M

Serious: 6/53 (11%)

Deaths: —

BL-Month 24: Romosozumab 210 mg QM

Serious: 7/51 (14%)

Deaths: —

Month 24-36: Placebo/Placebo

Serious: 2/18 (11%)

Deaths: —

Month 24-36: Placebo/Denosumab

Serious: 1/17 (6%)

Deaths: —

Month 24-36: ALN/Romosozumab/Placebo

Serious: 2/19 (11%)

Deaths: —

Month 24-36: ALN/Romosozumab/Denosumab

Serious: 0/19 (0%)

Deaths: —

Month 24-36: Romosozumab/Placebo

Serious: 3/90 (3%)

Deaths: —

Month 24-36: Romosozumab/Denosumab

Serious: 8/89 (9%)

Deaths: —

Month 36-48: Placebo/Placebo/Romosozumab

Serious: 0/12 (0%)

Deaths: —

Month 36-48: Placebo/Denosumab/Romosozumab

Serious: 1/15 (7%)

Deaths: —

Month 36-48: Romosozumab/Placebo/Romosozumab

Serious: 4/72 (6%)

Deaths: —

Month 36-48: Romosozumab/Denosumab/Romosozumab

Serious: 3/68 (4%)

Deaths: —

Month 48-72: Romosozumab/Denosumab/Romosozumab/No Intervention

Serious: 8/51 (16%)

Deaths: —

Month 48-72: Romosozumab/Placebo/Romosozumab/No

Serious: 0/3 (0%)

Deaths: —

Month 48-72: Placebo/Placebo/Romosozumab/Zoledronic Acid

Serious: 1/11 (9%)

Deaths: —

Month 48-72: Placebo/Denosumab/Romosozumab/Zoledronic

Serious: 1/12 (8%)

Deaths: —

Month 48-72: Romosozumab/Placebo/Romosozumab/Zoledronic Acid

Serious: 9/56 (16%)

Deaths: —

Month 48-72: Romosozumab/Denosumab/Romosozumab/Zoledronic Acid

Serious: 1/8 (13%)

Deaths: —

Serious adverse events (116 terms)

Reaction	System	BL-Month 12: Placebo QM	BL-Month 12: Placebo Q3M	BL-Month 12: Alendronate	BL-Month12: Teriparatide	BL-Month 12: Romosozumab 7…	BL-Month 12: Romosozumab 1…	BL-Month 12: Romosozumab 1…	BL-Month 12: Romosozumab 2…	BL-Month 12: Romosozumab 2…	BL-Month 24: Placebo QM	BL-Month 24: Placebo Q3M	BL-Month 24: ALN/Romosozum…	BL-Month 24: Romosozumab 7…	BL-Month 24: Romosozumab 1…	BL-Month 24: Romosozumab 1…	BL-Month 24: Romosozumab 2…	BL-Month 24: Romosozumab 2…	Month 24-36: Placebo/Placebo	Month 24-36: Placebo/Denos…	Month 24-36: ALN/Romosozum…	Month 24-36: ALN/Romosozum…	Month 24-36: Romosozumab/P…	Month 24-36: Romosozumab/D…	Month 36-48: Placebo/Place…	Month 36-48: Placebo/Denos…	Month 36-48: Romosozumab/P…	Month 36-48: Romosozumab/D…	Month 48-72: Romosozumab/D…	Month 48-72: Romosozumab/P…	Month 48-72: Placebo/Place…	Month 48-72: Placebo/Denos…	Month 48-72: Romosozumab/P…	Month 48-72: Romosozumab/D…
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pancytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Angina unstable	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrioventricular block second degree	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardiac tamponade	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Mitral valve stenosis	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sinus node dysfunction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperparathyroidism	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Iridocyclitis	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Barrett's oesophagus	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Colitis ischaemic	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diverticulum	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastric ulcer	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastrointestinal fistula	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastrointestinal necrosis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (218 terms — click to expand)

Reaction	System	BL-Month 12: Placebo QM	BL-Month 12: Placebo Q3M	BL-Month 12: Alendronate	BL-Month12: Teriparatide	BL-Month 12: Romosozumab 7…	BL-Month 12: Romosozumab 1…	BL-Month 12: Romosozumab 1…	BL-Month 12: Romosozumab 2…	BL-Month 12: Romosozumab 2…	BL-Month 24: Placebo QM	BL-Month 24: Placebo Q3M	BL-Month 24: ALN/Romosozum…	BL-Month 24: Romosozumab 7…	BL-Month 24: Romosozumab 1…	BL-Month 24: Romosozumab 1…	BL-Month 24: Romosozumab 2…	BL-Month 24: Romosozumab 2…	Month 24-36: Placebo/Placebo	Month 24-36: Placebo/Denos…	Month 24-36: ALN/Romosozum…	Month 24-36: ALN/Romosozum…	Month 24-36: Romosozumab/P…	Month 24-36: Romosozumab/D…	Month 36-48: Placebo/Place…	Month 36-48: Placebo/Denos…	Month 36-48: Romosozumab/P…	Month 36-48: Romosozumab/D…	Month 48-72: Romosozumab/D…	Month 48-72: Romosozumab/P…	Month 48-72: Placebo/Place…	Month 48-72: Placebo/Denos…	Month 48-72: Romosozumab/P…	Month 48-72: Romosozumab/D…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cataract	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sciatica	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection site bruising	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Pneumonia, Osteoarthritis, Pancytopenia, Acute myocardial infarction, Angina pectoris, Angina unstable, Atrial fibrillation, Atrioventricular block second degree.

Data from ClinicalTrials.gov NCT00896532 adverse events section.

Sponsor's own description

The primary objective was to determine the effect of treatment with romosozumab versus placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the lumbar spine in postmenopausal women with low bone density.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Osteoporosis: now and the future.
   Rachner TD, Khosla S, Hofbauer LC. · · 2011 · cited 1916× · PMID 21450337 · DOI 10.1016/s0140-6736(10)62349-5
2. Romosozumab in postmenopausal women with low bone mineral density.
   McClung MR, Grauer A, Boonen S, Bolognese MA, et al · · 2014 · cited 858× · PMID 24382002 · DOI 10.1056/nejmoa1305224
3. Wnt signaling in bone formation and its therapeutic potential for bone diseases.
   Kim JH, Liu X, Wang J, Chen X, et al · · 2013 · cited 252× · PMID 23514963 · DOI 10.1177/1759720x12466608
4. Wnt/β-catenin signaling components and mechanisms in bone formation, homeostasis, and disease.
   Hu L, Chen W, Qian A, Li YP. · · 2024 · cited 191× · PMID 38987555 · DOI 10.1038/s41413-024-00342-8
5. Effects of 24 Months of Treatment With Romosozumab Followed by 12 Months of Denosumab or Placebo in Postmenopausal Women With Low Bone Mineral Density: A Randomized, Double-Blind, Phase 2, Parallel Group Study.
   McClung MR, Brown JP, Diez-Perez A, Resch H, et al · · 2018 · cited 164× · PMID 29694685 · DOI 10.1002/jbmr.3452
6. Osteoporosis - a current view of pharmacological prevention and treatment.
   Das S, Crockett JC. · · 2013 · cited 143× · PMID 23807838 · DOI 10.2147/dddt.s31504
7. Antibodies to watch in 2015.
   Reichert JM. · · 2015 · cited 117× · PMID 25484055 · DOI 10.4161/19420862.2015.988944
8. Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab.
   Kendler DL, Bone HG, Massari F, Gielen E, et al · · 2019 · cited 82× · PMID 31628490 · DOI 10.1007/s00198-019-05146-9