Trial Outcomes & Findings for Study To Assess FRacTure Healing With SclerosTin Antibody - Hip (NCT NCT01081678)

Last Updated: 2022-09-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

332 participants

Primary outcome timeframe

Weeks 6, 12, 16, and 20

Results posted on

2022-09-21

Participant Flow

This study was conducted at 63 centers in 22 countries in Eastern Europe, Western Europe, India, North America, Latin America, Australia, New Zealand and Hong Kong.

Participants were randomized in a 2:3:3:3 ratio to 1 of 3 romosozumab treatment groups or placebo. Randomization followed operative fracture repair and was stratified by type of fracture, type of fixation device and age at entry. There were 7 randomization strata.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 70 mg Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 140 mg Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 210 mg Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Overall Study STARTED	89	60	93	90
Overall Study Received Study Drug	87	60	89	89
Overall Study Completed 24 Weeks of Study	73	50	72	68
Overall Study COMPLETED	62	44	62	61
Overall Study NOT COMPLETED	27	16	31	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 70 mg Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 140 mg Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 210 mg Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Overall Study Ineligibility Determined	0	0	1	1
Overall Study Noncompliance	3	4	5	2
Overall Study Adverse Event	2	1	2	2
Overall Study Withdrawal by Subject	15	7	17	14
Overall Study Administrative Decision	1	0	0	1
Overall Study Lost to Follow-up	4	1	4	3
Overall Study Death	2	2	2	6
Overall Study Other	0	1	0	0

Baseline Characteristics

Study To Assess FRacTure Healing With SclerosTin Antibody - Hip

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=89 Participants Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 70 mg n=60 Participants Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 140 mg n=93 Participants Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 210 mg n=90 Participants Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Total n=332 Participants Total of all reporting groups
Age, Continuous	76.0 years STANDARD_DEVIATION 8.6 • n=5 Participants	76.6 years STANDARD_DEVIATION 10.3 • n=7 Participants	75.8 years STANDARD_DEVIATION 10.1 • n=5 Participants	76.7 years STANDARD_DEVIATION 9.5 • n=4 Participants	76.3 years STANDARD_DEVIATION 9.5 • n=21 Participants
Age, Customized < 65 years	10 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants	11 Participants n=4 Participants	46 Participants n=21 Participants
Age, Customized ≥ 65 years	79 Participants n=5 Participants	52 Participants n=7 Participants	76 Participants n=5 Participants	79 Participants n=4 Participants	286 Participants n=21 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	42 Participants n=7 Participants	64 Participants n=5 Participants	55 Participants n=4 Participants	228 Participants n=21 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	18 Participants n=7 Participants	29 Participants n=5 Participants	35 Participants n=4 Participants	104 Participants n=21 Participants
Race/Ethnicity, Customized White	77 Participants n=5 Participants	52 Participants n=7 Participants	81 Participants n=5 Participants	70 Participants n=4 Participants	280 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Asian	12 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	19 Participants n=4 Participants	49 Participants n=21 Participants
Randomization Stratification Intertrochanteric, SHS and 55-75 years	13 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants	14 Participants n=4 Participants	50 Participants n=21 Participants
Randomization Stratification Intertrochanteric, SHS and ≥ 76 years	16 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants	16 Participants n=4 Participants	59 Participants n=21 Participants
Randomization Stratification Intertrochanteric, IM Nail and 55-75 years	15 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants	16 Participants n=4 Participants	58 Participants n=21 Participants
Randomization Stratification Intertrochanteric, IM Nail and ≥ 76 years	33 Participants n=5 Participants	22 Participants n=7 Participants	34 Participants n=5 Participants	33 Participants n=4 Participants	122 Participants n=21 Participants
Randomization Stratification Displaced femoral neck and SHS	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants
Randomization Stratification Displaced femoral neck and cancellous screws	6 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	21 Participants n=21 Participants
Randomization Stratification Undisplaced femoral neck	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants

PRIMARY outcome

Timeframe: Weeks 6, 12, 16, and 20

Population: Randomized participants who received at least one dose of study drug with available data at each time point.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 70 mg n=60 Participants Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 140 mg n=89 Participants Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 210 mg n=89 Participants Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20 Week 6	54.1 seconds Interval 44.4 to 66.0	41.0 seconds Interval 32.4 to 51.9	47.2 seconds Interval 38.9 to 57.4	53.3 seconds Interval 43.8 to 64.8
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20 Week 20	23.8 seconds Interval 20.3 to 28.0	21.9 seconds Interval 18.1 to 26.6	22.9 seconds Interval 19.5 to 26.8	29.1 seconds Interval 24.8 to 34.2
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20 Week 12	29.8 seconds Interval 25.3 to 35.2	27.6 seconds Interval 22.7 to 33.5	30.0 seconds Interval 25.6 to 35.2	36.1 seconds Interval 30.7 to 42.5
Timed-Up-and-Go (TUG) Over Week 6 Through Week 20 Week 16	26.2 seconds Interval 22.2 to 30.8	23.3 seconds Interval 19.2 to 28.3	26.9 seconds Interval 23.0 to 31.6	31.8 seconds Interval 27.1 to 37.4

SECONDARY outcome

Timeframe: Weeks 2, 6, 12, 16, 20, 24, 36, and 52

Population: Randomized participants who received at least 1 dose of study drug. LOCF imputation was used when possible, as described above.

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.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 70 mg n=60 Participants Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 140 mg n=89 Participants Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 210 mg n=89 Participants Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Timed-Up-and-Go (TUG) at Each Visit Week 2	132.3 seconds Interval 111.0 to 153.6	119.3 seconds Interval 94.2 to 144.4	121.7 seconds Interval 101.0 to 142.5	129.8 seconds Interval 108.9 to 150.7
Timed-Up-and-Go (TUG) at Each Visit Week 6	92.4 seconds Interval 74.9 to 109.9	69.5 seconds Interval 48.6 to 90.4	80.3 seconds Interval 63.1 to 97.5	86.7 seconds Interval 69.3 to 104.0
Timed-Up-and-Go (TUG) at Each Visit Week 12	47.4 seconds Interval 37.6 to 57.1	39.1 seconds Interval 27.4 to 50.7	44.6 seconds Interval 35.1 to 54.1	56.3 seconds Interval 46.6 to 65.9
Timed-Up-and-Go (TUG) at Each Visit Week 16	43.1 seconds Interval 34.1 to 52.1	31.6 seconds Interval 20.9 to 42.4	39.7 seconds Interval 30.9 to 48.6	50.1 seconds Interval 41.2 to 59.1
Timed-Up-and-Go (TUG) at Each Visit Week 20	36.4 seconds Interval 28.3 to 44.6	31.0 seconds Interval 21.2 to 40.7	35.1 seconds Interval 27.1 to 43.1	45.6 seconds Interval 37.5 to 53.8
Timed-Up-and-Go (TUG) at Each Visit Week 24	33.3 seconds Interval 25.8 to 40.7	28.9 seconds Interval 20.1 to 37.8	31.7 seconds Interval 24.4 to 39.0	40.9 seconds Interval 33.5 to 48.4
Timed-Up-and-Go (TUG) at Each Visit Week 36	32.4 seconds Interval 25.1 to 39.7	26.3 seconds Interval 17.5 to 35.0	29.8 seconds Interval 22.5 to 37.0	38.7 seconds Interval 31.3 to 46.0
Timed-Up-and-Go (TUG) at Each Visit Week 52	28.7 seconds Interval 22.2 to 35.1	22.8 seconds Interval 15.2 to 30.5	28.8 seconds Interval 22.5 to 35.2	36.3 seconds Interval 29.8 to 42.7

SECONDARY outcome

Timeframe: 52 weeks

Population: All randomized participants who received at least one dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 70 mg n=60 Participants Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 140 mg n=89 Participants Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 210 mg n=89 Participants Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Time to Radiographic Healing	16.4 weeks Interval 15.3 to 20.1	16.9 weeks Interval 12.9 to 20.3	16.6 weeks Interval 13.3 to 17.1	16.9 weeks Interval 13.3 to 20.9

SECONDARY outcome

Timeframe: Weeks 2, 6, 12, 16, 20, 24, 36, and 52

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 70 mg n=60 Participants Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 140 mg n=89 Participants Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 210 mg n=89 Participants Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Radiographic Union Scale for Hip (RUSH) Score At Each Visit Week 2	12.1 units on a scale Standard Deviation 3.3	12.7 units on a scale Standard Deviation 3.5	12.1 units on a scale Standard Deviation 3.4	12.0 units on a scale Standard Deviation 3.1
Radiographic Union Scale for Hip (RUSH) Score At Each Visit Week 6	18.1 units on a scale Standard Deviation 3.6	18.0 units on a scale Standard Deviation 4.2	18.4 units on a scale Standard Deviation 3.4	18.3 units on a scale Standard Deviation 4.0
Radiographic Union Scale for Hip (RUSH) Score At Each Visit Week 12	23.3 units on a scale Standard Deviation 4.6	22.8 units on a scale Standard Deviation 4.8	22.9 units on a scale Standard Deviation 4.8	22.3 units on a scale Standard Deviation 5.3
Radiographic Union Scale for Hip (RUSH) Score At Each Visit Week 16	25.6 units on a scale Standard Deviation 4.3	25.7 units on a scale Standard Deviation 4.5	25.5 units on a scale Standard Deviation 5.0	25.5 units on a scale Standard Deviation 4.7
Radiographic Union Scale for Hip (RUSH) Score At Each Visit Week 20	26.8 units on a scale Standard Deviation 4.1	27.3 units on a scale Standard Deviation 4.1	27.4 units on a scale Standard Deviation 4.0	26.4 units on a scale Standard Deviation 4.6
Radiographic Union Scale for Hip (RUSH) Score At Each Visit Week 24	27.8 units on a scale Standard Deviation 3.4	27.8 units on a scale Standard Deviation 3.9	28.3 units on a scale Standard Deviation 3.5	27.3 units on a scale Standard Deviation 3.9
Radiographic Union Scale for Hip (RUSH) Score At Each Visit Week 36	28.7 units on a scale Standard Deviation 2.6	28.3 units on a scale Standard Deviation 3.6	29.1 units on a scale Standard Deviation 2.1	28.2 units on a scale Standard Deviation 3.5
Radiographic Union Scale for Hip (RUSH) Score At Each Visit Week 52	29.4 units on a scale Standard Deviation 2.0	28.5 units on a scale Standard Deviation 3.8	29.6 units on a scale Standard Deviation 1.8	28.7 units on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: Weeks 2, 6, 12, 16, 20, 24, 36, and 52

Population: Randomized participants who received at least 1 dose of study drug with available data at each time point.

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.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 70 mg n=60 Participants Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 140 mg n=89 Participants Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 210 mg n=89 Participants Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Harris Hip Score At Each Visit Week 2	46.6 units on a scale Interval 43.1 to 50.1	47.7 units on a scale Interval 43.6 to 51.9	47.3 units on a scale Interval 43.9 to 50.8	46.5 units on a scale Interval 43.1 to 50.0
Harris Hip Score At Each Visit Week 6	58.6 units on a scale Interval 55.1 to 62.1	62.5 units on a scale Interval 58.3 to 66.7	61.6 units on a scale Interval 58.1 to 65.0	59.5 units on a scale Interval 55.9 to 63.0
Harris Hip Score At Each Visit Week 12	71.2 units on a scale Interval 67.9 to 74.5	70.9 units on a scale Interval 67.0 to 74.9	71.7 units on a scale Interval 68.3 to 75.1	69.6 units on a scale Interval 66.2 to 72.9
Harris Hip Score At Each Visit Week 16	74.1 units on a scale Interval 70.8 to 77.4	76.5 units on a scale Interval 72.6 to 80.5	76.1 units on a scale Interval 72.7 to 79.4	72.8 units on a scale Interval 69.4 to 76.2
Harris Hip Score At Each Visit Week 20	76.2 units on a scale Interval 73.0 to 79.3	80.2 units on a scale Interval 76.4 to 83.9	80.5 units on a scale Interval 77.4 to 83.6	77.5 units on a scale Interval 74.3 to 80.7
Harris Hip Score At Each Visit Week 24	79.0 units on a scale Interval 76.2 to 81.8	80.3 units on a scale Interval 76.8 to 83.7	83.0 units on a scale Interval 80.1 to 85.8	80.1 units on a scale Interval 77.2 to 83.0
Harris Hip Score At Each Visit Week 36	80.3 units on a scale Interval 77.0 to 83.6	82.0 units on a scale Interval 78.1 to 85.8	86.8 units on a scale Interval 83.5 to 90.2	83.6 units on a scale Interval 80.2 to 86.9
Harris Hip Score At Each Visit Week 52	84.3 units on a scale Interval 81.3 to 87.4	86.7 units on a scale Interval 83.0 to 90.3	89.0 units on a scale Interval 85.9 to 92.1	83.8 units on a scale Interval 80.7 to 86.9

SECONDARY outcome

Timeframe: Weeks 2, 6, 12, 16, 20, 24, 36, and 52

Population: Randomized participants who received at least 1 dose of study drug with available data at each time point.

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.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 70 mg n=60 Participants Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 140 mg n=89 Participants Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 210 mg n=89 Participants Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Hip Pain Score at Each Visit Week 2	34.3 units on a scale Interval 28.2 to 40.4	33.1 units on a scale Interval 25.9 to 40.3	40.3 units on a scale Interval 34.4 to 46.2	43.0 units on a scale Interval 37.1 to 48.9
Hip Pain Score at Each Visit Week 6	26.3 units on a scale Interval 20.8 to 31.7	19.5 units on a scale Interval 13.1 to 26.0	25.1 units on a scale Interval 19.7 to 30.4	27.5 units on a scale Interval 22.1 to 32.9
Hip Pain Score at Each Visit Week 12	19.4 units on a scale Interval 14.1 to 24.8	17.8 units on a scale Interval 11.5 to 24.1	17.5 units on a scale Interval 12.1 to 22.8	23.7 units on a scale Interval 18.3 to 29.0
Hip Pain Score at Each Visit Week 16	18.1 units on a scale Interval 13.0 to 23.3	13.5 units on a scale Interval 7.4 to 19.6	16.8 units on a scale Interval 11.8 to 21.8	17.4 units on a scale Interval 12.2 to 22.5
Hip Pain Score at Each Visit Week 20	15.8 units on a scale Interval 11.2 to 20.4	9.2 units on a scale Interval 3.8 to 14.7	14.0 units on a scale Interval 9.5 to 18.5	15.0 units on a scale Interval 10.5 to 19.6
Hip Pain Score at Each Visit Week 24	13.8 units on a scale Interval 9.6 to 18.0	9.1 units on a scale Interval 4.0 to 14.2	12.7 units on a scale Interval 8.4 to 17.0	13.1 units on a scale Interval 8.8 to 17.3
Hip Pain Score at Each Visit Week 36	14.3 units on a scale Interval 9.6 to 19.0	10.9 units on a scale Interval 5.4 to 16.4	11.6 units on a scale Interval 6.8 to 16.3	10.2 units on a scale Interval 5.5 to 14.9
Hip Pain Score at Each Visit Week 52	13.4 units on a scale Interval 9.2 to 17.7	7.2 units on a scale Interval 2.1 to 12.3	9.3 units on a scale Interval 5.1 to 13.5	10.4 units on a scale Interval 6.2 to 14.6

Adverse Events

Placebo

Serious events: 25 serious events

Other events: 31 other events

Deaths: 0 deaths

Romosozumab 70 mg

Serious events: 9 serious events

Other events: 24 other events

Deaths: 0 deaths

Romosozumab 140 mg

Serious events: 15 serious events

Other events: 30 other events

Deaths: 0 deaths

Romosozumab 210 mg

Serious events: 26 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=87 participants at risk Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 70 mg n=60 participants at risk Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 140 mg n=89 participants at risk Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.	Romosozumab 210 mg n=89 participants at risk Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Gastrointestinal disorders Constipation	12.6% 11/87 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.0% 6/60 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.1% 9/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.7% 6/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	9.2% 8/87 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.3% 2/60 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.2% 2/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 4/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	8.0% 7/87 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.7% 4/60 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.9% 7/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.2% 2/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pyrexia	0.00% 0/87 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 3/60 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.2% 2/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.4% 3/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	9.2% 8/87 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.7% 4/60 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.0% 8/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 4/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Contusion	1.1% 1/87 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 3/60 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural pain	5.7% 5/87 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.7% 1/60 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.6% 5/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.2% 2/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	2.3% 2/87 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 3/60 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.7% 6/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.6% 5/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/87 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.7% 7/60 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.6% 5/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 4/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.1% 1/87 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 3/60 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.6% 5/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.2% 2/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 5/87 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/60 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.2% 2/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	3.4% 3/87 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.7% 4/60 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.6% 5/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 4/89 • 52 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER