Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 14 of 14

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Observed Serum Concentration (Cmax) of Romosozumab	Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, 85, 113, and 169 (end of study); pre-specified PK analysis took place on Days 1 and 57	Pharmacokinetic (PK) Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested.	μg/mL	MEAN
PRIMARY	Time to Cmax (Tmax) of Romosozumab	Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, 85, 113, and 169 (end of study); pre-specified PK analysis took place on Days 1 and 57	PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested.	day	MEDIAN
PRIMARY	Area Under the Serum Concentration Time Curve (AUC) From Time 0 to Day 28 (AUC[0-28]) of Romosozumab	Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, and 85; pre-specified PK analysis took place on Days 1 and 57	PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested.	day*μg/mL	MEAN
PRIMARY	Accumulation Ratio of Romosozumab	Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, and 85; pre-specified PK analysis took place on Days 1 and 57	PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested.	ratio	MEAN
PRIMARY	Terminal Half-life of Romosozumab	Single blood samples were taken on days 1, 8, 15, 29, 57, 64, 71, 85, 113, and 169 (end of study); pre-specified PK analysis took place on Day 57	PK Analysis Set: all participants for whom at least 1 PK parameter or endpoint could be adequately tested. Data is presented for participants with evaluable data.	day	MEDIAN
SECONDARY	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Day 1 to end of study (up to Day 169); median duration on study was 5.55 months	Safety Analysis Set: all participants enrolled in the study who received at least 1 dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Changes From Baseline in Cranial Nerve VII Examination Findings at Day 57, Day 85, and Day 169	Baseline (Day 1), Day 57, Day 85, and Day 169	Safety Analysis Set: all participants enrolled in the study who received at least 1 dose of investigational product. Participants with data available at each time point are presented.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Anti-romosozumab Antibodies	Blood samples for anti-romosozumab antibodies were taken Day 1, Day 15, Day 29, Day 85, and Day 169	Safety Analysis Set: all participants enrolled in the study who received at least 1 dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage Change From Baseline in Serum Concentrations of Serum Type 1 Collagen C-Telopeptide (CTX)	Blood samples were taken Days 1 (baseline), 8, 15, 29, 57, 64, 71, 85, 113, and 169	PD Analysis Set: all participants for whom at least 1 PD parameter or endpoint could be adequately estimated. Participants with data available at each time point are presented.	percentage change	MEAN
SECONDARY	Percentage Change From Baseline in Serum Concentrations of Procollagen Type 1 N-terminal Propeptide (P1NP)	Blood samples were taken Days 1 (baseline), 8, 15, 29, 57, 64, 71, 85, 113, and 169	PD Analysis Set: all participants for whom at least 1 PD parameter or endpoint could be adequately estimated. Participants with data available at each time point are presented.	percentage change	MEAN
SECONDARY	Percentage Change From Baseline in Bone Mineral Density (BMD) of the Lumbar Spine	DXA scans were during screening (baseline) and at Day 85 and Day 169	The BMD Analysis Set: all participants who have a baseline lumbar spine DXA BMD measurement and at least 1 post-baseline lumbar spine DXA BMD measurement. Participants with data available at each time point are presented.	percentage change	MEAN
SECONDARY	Percentage Change From Baseline in Bone Mineral Content (BMC) of the Lumbar Spine	DXA scans were during screening (baseline) and at Day 85 and Day 169	The BMD Analysis Set: all participants who have a baseline lumbar spine DXA BMD measurement and at least 1 post-baseline lumbar spine DXA BMD measurement. Participants with data available at each time point are presented.	percentage change	MEAN
SECONDARY	Percentage Change From Baseline in Lumbar Spine Bone Area	DXA scans were during screening (baseline) and at Day 85 and Day 169	The BMD Analysis Set: all participants who have a baseline lumbar spine DXA BMD measurement and at least 1 post-baseline lumbar spine DXA BMD measurement.	percentage change	MEAN
SECONDARY	Mean Change From Baseline in Lumbar Spine BMD Z-Score	DXA scans were during screening (baseline) and at Day 85 and Day 169	The BMD Analysis Set: all participants who have a baseline lumbar spine DXA BMD measurement and at least 1 post-baseline lumbar spine DXA BMD measurement. Participants with data available at each time point are presented.	Z-score	MEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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