Trial · NCT01081678

Study To Assess FRacTure Healing With SclerosTin Antibody - Hip

NCT01081678, Phase 2, Completed, Amgen; results first posted 2019-05-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study To Assess FRacTure Healing With SclerosTin Antibody - Hip. Trials, record NCT01081678. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01081678

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
NCT number: NCT01081678
Status: Completed
Phases: Phase 2
Enrollment: 332 participants, actual
Lead sponsor: Amgen
Conditions: Fracture Healing
Interventions: Placebo, Romosozumab
First posted: 2010-03-05
Last updated: 2022-09-21
Results first posted: 2019-05-02

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Timed-Up-and-Go (TUG) Over Week 6 Through Week 20	Weeks 6, 12, 16, and 20	Functional healing was measured by the timed-up-and-go test (TUG) over Weeks 6 through 20. During this assessment, the clinician timed the participant while they stood up from a seated position in a chair, walked three meters, turned around, walked three meters back to the chair, and returned to the seated position. A TUG value of ten seconds or less was considered normal for a healthy elderly person. Higher TUG values after hip fracture have been shown to be a predictor of future falls. Least squares mean (LSM) estimates were based on a repeated measures model fitted with the log-transformed TUG values at weeks 2, 6, 12, 16, 20, 24, 36, 52 as the dependent variable and adjusted for treatment, randomized strata, gender, country category, pre-fracture community-dwelling status, pre-fracture walking aid use, quality of surgical fixation, visit, and treatment-by-visit interaction and back-transformed using the exponential transformation.
Secondary	Timed-Up-and-Go (TUG) at Each Visit	Weeks 2, 6, 12, 16, 20, 24, 36, and 52	During the timed-up-and-go test the clinician timed the participant while they stood up from a seated position in a chair, walked 3 meters, turned around, walked 3 meters back to the chair, and returned to a seated position. A TUG value of ≤ 10 seconds is considered normal for a healthy elderly person. LSMs were based on a repeated measures model adjusting for treatment, randomized strata, gender, country category, pre-fracture community-dwelling status, pre-fracture walking aid use, quality of surgical fixation, visit, and treatment-by-visit interaction. Missing TUG values for participants still on study were imputed using the last observation carried forward (LOCF) when possible. If no observation could be carried forward, the maximum TUG value observed among all participants at a given visit was used. TUG values obtained after unplanned revision surgery were replaced by carrying forward the last available observed or imputed value prior to unplanned revision surgery.
Secondary	Time to Radiographic Healing	52 weeks	Time to radiographic healing is the time interval from the surgery date for the eligible hip fracture to the date of radiographic healing, defined as effacement of the fracture lines by newly formed bone along the cortices and within the trabecular bone on anteroposterior and lateral (or oblique) radiographs. Radiographic fracture healing was determined by a panel of independent reviewers blinded to treatment. The cumulative incidence function (CIF) method was used to estimate the median time to radiographic healing and the confidence intervals. Unplanned revision surgery to promote healing was considered a competing risk in CIF estimate.
Secondary	Radiographic Union Scale for Hip (RUSH) Score At Each Visit	Weeks 2, 6, 12, 16, 20, 24, 36, and 52	The radiographic Union Scale for Hip (RUSH) is a semiquantitative scoring assessment to assess hip fracture healing after surgical repair. The RUSH has 4 key domains based on radiographic parameters used by orthopedic surgeons and radiologists in routine clinical practice including cortical bridging (4 to 12 points), cortical fracture line disappearance (4 to 12 points), trabecular consolidation (1 to 3 points), and trabecular index disappearance of fracture line (1 to 3 points). The score has a minimum of 10 points (definitely not healed) and a maximum of 30 points (definitely healed).
Secondary	Harris Hip Score At Each Visit	Weeks 2, 6, 12, 16, 20, 24, 36, and 52	The Harris Hip Score is a clinician-based outcome that assesses pain, function, deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities and gait. Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. The score ranges form 0-100 (best possible outcome) covering pain (0-44 points), function (0-47 points), absence of deformity (4 points), and range of motion (5 points). LSMs were based on a repeated measures model fitted with the Harris hip score values at weeks 2, 6, 12, 16, 20, 24, 36, and 52 as the dependent variable and adjusted for treatment, randomized strata, gender, pre-fracture community-dwelling status, pre-fracture walking aid use, quality of surgical fixation, visit, and treatment-by-visit interaction.
Secondary	Hip Pain Score at Each Visit	Weeks 2, 6, 12, 16, 20, 24, 36, and 52	Hip pain was assessed using a visual analog scale (VAS). Participants were asked to rate their pain as a result of the hip fracture on a 100 mm vertical scale with 0 indicating no pain at all and 100 indicating the worst pain they could imagine. LSMs were based on a repeated measures model fitted with hip pain score values at weeks 2, 6, 12, 16, 20, 24, 36, and 52 as the dependent variable and adjusted for treatment, randomized strata, gender, pre-fracture community-dwelling status, pre-fracture walking aid use, quality of surgical fixation, visit, and treatment-by-visit interaction.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Timed-Up-and-Go (TUG) Over Week 6 Through Week 20	Weeks 6, 12, 16, and 20	Randomized participants who received at least one dose of study drug with available data at each time point.	seconds	LEAST_SQUARES_MEAN
SECONDARY	Timed-Up-and-Go (TUG) at Each Visit	Weeks 2, 6, 12, 16, 20, 24, 36, and 52	Randomized participants who received at least 1 dose of study drug. LOCF imputation was used when possible, as described above.	seconds	LEAST_SQUARES_MEAN
SECONDARY	Time to Radiographic Healing	52 weeks	All randomized participants who received at least one dose of study drug.	weeks	MEDIAN
SECONDARY	Radiographic Union Scale for Hip (RUSH) Score At Each Visit	Weeks 2, 6, 12, 16, 20, 24, 36, and 52	Randomized participants who received at least 1 dose of study drug, with available data at baseline and at each time point. Missing RUSH scores for participants who were still on study were imputed using the using last observation carried forward procedure when possible.	units on a scale	MEAN
SECONDARY	Harris Hip Score At Each Visit	Weeks 2, 6, 12, 16, 20, 24, 36, and 52	Randomized participants who received at least 1 dose of study drug with available data at each time point.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Hip Pain Score at Each Visit	Weeks 2, 6, 12, 16, 20, 24, 36, and 52	Randomized participants who received at least 1 dose of study drug with available data at each time point.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group148

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20	Placebo	Week 6	54.1	95% Confidence Interval 44.4 to 66.0	seconds
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20	Romosozumab 70 mg	Week 6	41.0	95% Confidence Interval 32.4 to 51.9	seconds
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20	Romosozumab 140 mg	Week 6	47.2	95% Confidence Interval 38.9 to 57.4	seconds
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20	Romosozumab 210 mg	Week 6	53.3	95% Confidence Interval 43.8 to 64.8	seconds
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20	Placebo	Week 12	29.8	95% Confidence Interval 25.3 to 35.2	seconds
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20	Romosozumab 70 mg	Week 12	27.6	95% Confidence Interval 22.7 to 33.5	seconds
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20	Romosozumab 140 mg	Week 12	30.0	95% Confidence Interval 25.6 to 35.2	seconds
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20	Romosozumab 210 mg	Week 12	36.1	95% Confidence Interval 30.7 to 42.5	seconds
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20	Placebo	Week 16	26.2	95% Confidence Interval 22.2 to 30.8	seconds
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20	Romosozumab 70 mg	Week 16	23.3	95% Confidence Interval 19.2 to 28.3	seconds

1 to 10 of 148Source ClinicalTrials.gov

See all 148 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	89
Overall Study	STARTED	Romosozumab 70 mg	60
Overall Study	STARTED	Romosozumab 140 mg	93
Overall Study	STARTED	Romosozumab 210 mg	90
Overall Study	Received Study Drug	Placebo	87
Overall Study	Received Study Drug	Romosozumab 70 mg	60
Overall Study	Received Study Drug	Romosozumab 140 mg	89
Overall Study	Received Study Drug	Romosozumab 210 mg	89
Overall Study	Completed 24 Weeks of Study	Placebo	73
Overall Study	Completed 24 Weeks of Study	Romosozumab 70 mg	50

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events372

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Constipation	Gastrointestinal disorders	Placebo	11	87
other	Constipation	Gastrointestinal disorders	Romosozumab 70 mg	6	60
other	Constipation	Gastrointestinal disorders	Romosozumab 140 mg	9	89
other	Constipation	Gastrointestinal disorders	Romosozumab 210 mg	6	89
other	Diarrhoea	Gastrointestinal disorders	Placebo	8	87
other	Diarrhoea	Gastrointestinal disorders	Romosozumab 70 mg	2	60
other	Diarrhoea	Gastrointestinal disorders	Romosozumab 140 mg	2	89
other	Diarrhoea	Gastrointestinal disorders	Romosozumab 210 mg	4	89
other	Nausea	Gastrointestinal disorders	Placebo	7	87
other	Nausea	Gastrointestinal disorders	Romosozumab 70 mg	4	60

1 to 10 of 372Source ClinicalTrials.gov

See all 372 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Romosozumab 70 mg
Total, all-cause mortality	Romosozumab 140 mg
Total, all-cause mortality	Romosozumab 210 mg
Total, other adverse events	Placebo	31	87
Total, other adverse events	Romosozumab 70 mg	24	60
Total, other adverse events	Romosozumab 140 mg	30	89
Total, other adverse events	Romosozumab 210 mg	26	89
Total, serious adverse events	Placebo	25	87
Total, serious adverse events	Romosozumab 70 mg	9	60

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31977817	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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