A Phase 2 interventional study of Placebo and Romosozumab in Fracture Healing, sponsored by Amgen. Completed at 99 sites in 24 countries. Open to participants aged 55 Years to 95 Years. Per ClinicalTrials.gov, last updated 2022-09-21.
Sponsored by Amgen · Phase 2, Interventional, and Treatment
This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 332 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
internal fixation of the fracture with devices approved by local regulatory agency, performed no later than 7 days after injury for intertrochanteric or undisplaced femoral neck fractures and no later than 2 days after injury for displaced femoral neck fractures
Exclusion Criteria:
Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Drug: Placebo
Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Drug: Romosozumab
Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Drug: Romosozumab
Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Drug: Romosozumab
Administered by subcutaneous (under the skin) injection
Administered by subcutaneous injection
Also known as: AMG 785, Evenity
Timed-Up-and-Go (TUG) Over Week 6 Through Week 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.
Time frame: Weeks 6, 12, 16, and 20
Timed-Up-and-Go (TUG) at Each Visit
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.
Time frame: Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Time to Radiographic Healing
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.
Time frame: 52 weeks
Radiographic Union Scale for Hip (RUSH) Score At Each Visit
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).
Time frame: Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Harris Hip Score At Each Visit
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.
Time frame: Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Hip Pain Score at Each Visit
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.
Time frame: Weeks 2, 6, 12, 16, 20, 24, 36, and 52
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.
| Milestone | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg |
|---|---|---|---|---|
| Started | 89 | 60 | 93 | 90 |
| Received study drug | 87 | 60 | 89 | 89 |
| Completed 24 weeks of study | 73 | 50 | 72 | 68 |
| Completed | 62 | 44 | 62 | 61 |
| Not completed | 27 | 16 | 31 | 29 |
| Withdrew: Ineligibility determined | 0 | 0 | 1 | 1 |
| Withdrew: Noncompliance | 3 | 4 | 5 | 2 |
| Withdrew: Adverse event | 2 | 1 | 2 | 2 |
| Withdrew: Withdrawal by subject | 15 | 7 | 17 | 14 |
| Withdrew: Administrative decision | 1 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 4 | 1 | 4 | 3 |
| Withdrew: Death | 2 | 2 | 2 | 6 |
| Withdrew: Other | 0 | 1 | 0 | 0 |
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.
| seconds | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg |
|---|---|---|---|---|
| Week 6 | 54.1 (44.4 to 66.0) | 41.0 (32.4 to 51.9) | 47.2 (38.9 to 57.4) | 53.3 (43.8 to 64.8) |
| Week 12 | 29.8 (25.3 to 35.2) | 27.6 (22.7 to 33.5) | 30.0 (25.6 to 35.2) | 36.1 (30.7 to 42.5) |
| Week 16 | 26.2 (22.2 to 30.8) | 23.3 (19.2 to 28.3) | 26.9 (23.0 to 31.6) | 31.8 (27.1 to 37.4) |
| Week 20 | 23.8 (20.3 to 28.0) | 21.9 (18.1 to 26.6) | 22.9 (19.5 to 26.8) | 29.1 (24.8 to 34.2) |
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.
| seconds | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg |
|---|---|---|---|---|
| Week 2 | 132.3 (111.0 to 153.6) | 119.3 (94.2 to 144.4) | 121.7 (101.0 to 142.5) | 129.8 (108.9 to 150.7) |
| Week 6 | 92.4 (74.9 to 109.9) | 69.5 (48.6 to 90.4) | 80.3 (63.1 to 97.5) | 86.7 (69.3 to 104.0) |
| Week 12 | 47.4 (37.6 to 57.1) | 39.1 (27.4 to 50.7) | 44.6 (35.1 to 54.1) | 56.3 (46.6 to 65.9) |
| Week 16 | 43.1 (34.1 to 52.1) | 31.6 (20.9 to 42.4) | 39.7 (30.9 to 48.6) | 50.1 (41.2 to 59.1) |
| Week 20 | 36.4 (28.3 to 44.6) | 31.0 (21.2 to 40.7) | 35.1 (27.1 to 43.1) | 45.6 (37.5 to 53.8) |
| Week 24 | 33.3 (25.8 to 40.7) | 28.9 (20.1 to 37.8) | 31.7 (24.4 to 39.0) | 40.9 (33.5 to 48.4) |
| Week 36 | 32.4 (25.1 to 39.7) | 26.3 (17.5 to 35.0) | 29.8 (22.5 to 37.0) | 38.7 (31.3 to 46.0) |
| Week 52 | 28.7 (22.2 to 35.1) | 22.8 (15.2 to 30.5) | 28.8 (22.5 to 35.2) | 36.3 (29.8 to 42.7) |
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.
| weeks | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg |
|---|---|---|---|---|
| Time to Radiographic Healing | 16.4 (15.3 to 20.1) | 16.9 (12.9 to 20.3) | 16.6 (13.3 to 17.1) | 16.9 (13.3 to 20.9) |
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).
| units on a scale | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg |
|---|---|---|---|---|
| Week 2 | 12.1 ± 3.3 | 12.7 ± 3.5 | 12.1 ± 3.4 | 12.0 ± 3.1 |
| Week 6 | 18.1 ± 3.6 | 18.0 ± 4.2 | 18.4 ± 3.4 | 18.3 ± 4.0 |
| Week 12 | 23.3 ± 4.6 | 22.8 ± 4.8 | 22.9 ± 4.8 | 22.3 ± 5.3 |
| Week 16 | 25.6 ± 4.3 | 25.7 ± 4.5 | 25.5 ± 5.0 | 25.5 ± 4.7 |
| Week 20 | 26.8 ± 4.1 | 27.3 ± 4.1 | 27.4 ± 4.0 | 26.4 ± 4.6 |
| Week 24 | 27.8 ± 3.4 | 27.8 ± 3.9 | 28.3 ± 3.5 | 27.3 ± 3.9 |
| Week 36 | 28.7 ± 2.6 | 28.3 ± 3.6 | 29.1 ± 2.1 | 28.2 ± 3.5 |
| Week 52 | 29.4 ± 2.0 | 28.5 ± 3.8 | 29.6 ± 1.8 | 28.7 ± 3.3 |
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.
| units on a scale | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg |
|---|---|---|---|---|
| Week 2 | 46.6 (43.1 to 50.1) | 47.7 (43.6 to 51.9) | 47.3 (43.9 to 50.8) | 46.5 (43.1 to 50.0) |
| Week 6 | 58.6 (55.1 to 62.1) | 62.5 (58.3 to 66.7) | 61.6 (58.1 to 65.0) | 59.5 (55.9 to 63.0) |
| Week 12 | 71.2 (67.9 to 74.5) | 70.9 (67.0 to 74.9) | 71.7 (68.3 to 75.1) | 69.6 (66.2 to 72.9) |
| Week 16 | 74.1 (70.8 to 77.4) | 76.5 (72.6 to 80.5) | 76.1 (72.7 to 79.4) | 72.8 (69.4 to 76.2) |
| Week 20 | 76.2 (73.0 to 79.3) | 80.2 (76.4 to 83.9) | 80.5 (77.4 to 83.6) | 77.5 (74.3 to 80.7) |
| Week 24 | 79.0 (76.2 to 81.8) | 80.3 (76.8 to 83.7) | 83.0 (80.1 to 85.8) | 80.1 (77.2 to 83.0) |
| Week 36 | 80.3 (77.0 to 83.6) | 82.0 (78.1 to 85.8) | 86.8 (83.5 to 90.2) | 83.6 (80.2 to 86.9) |
| Week 52 | 84.3 (81.3 to 87.4) | 86.7 (83.0 to 90.3) | 89.0 (85.9 to 92.1) | 83.8 (80.7 to 86.9) |
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.
| units on a scale | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg |
|---|---|---|---|---|
| Week 2 | 34.3 (28.2 to 40.4) | 33.1 (25.9 to 40.3) | 40.3 (34.4 to 46.2) | 43.0 (37.1 to 48.9) |
| Week 6 | 26.3 (20.8 to 31.7) | 19.5 (13.1 to 26.0) | 25.1 (19.7 to 30.4) | 27.5 (22.1 to 32.9) |
| Week 12 | 19.4 (14.1 to 24.8) | 17.8 (11.5 to 24.1) | 17.5 (12.1 to 22.8) | 23.7 (18.3 to 29.0) |
| Week 16 | 18.1 (13.0 to 23.3) | 13.5 (7.4 to 19.6) | 16.8 (11.8 to 21.8) | 17.4 (12.2 to 22.5) |
| Week 20 | 15.8 (11.2 to 20.4) | 9.2 (3.8 to 14.7) | 14.0 (9.5 to 18.5) | 15.0 (10.5 to 19.6) |
| Week 24 | 13.8 (9.6 to 18.0) | 9.1 (4.0 to 14.2) | 12.7 (8.4 to 17.0) | 13.1 (8.8 to 17.3) |
| Week 36 | 14.3 (9.6 to 19.0) | 10.9 (5.4 to 16.4) | 11.6 (6.8 to 16.3) | 10.2 (5.5 to 14.9) |
| Week 52 | 13.4 (9.2 to 17.7) | 7.2 (2.1 to 12.3) | 9.3 (5.1 to 13.5) | 10.4 (6.2 to 14.6) |
Collected over 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 25/87 (28.7%) | 31/87 (35.6%) |
| Romosozumab 70 mg | — | 9/60 (15%) | 24/60 (40%) |
| Romosozumab 140 mg | — | 15/89 (16.9%) | 30/89 (33.7%) |
| Romosozumab 210 mg | — | 26/89 (29.2%) | 26/89 (29.2%) |
| Event | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg |
|---|---|---|---|---|
| CellulitisInfections and infestations | 3/87 | 0/60 | 1/89 | 1/89 |
| Postoperative wound infectionInfections and infestations | 0/87 | 0/60 | 0/89 | 3/89 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/87 | 0/60 | 0/89 | 0/89 |
| Acute myocardial infarctionCardiac disorders | 1/87 | 0/60 | 1/89 | 2/89 |
| PneumoniaInfections and infestations | 1/87 | 0/60 | 1/89 | 2/89 |
| Hip fractureInjury, poisoning and procedural complications | 0/87 | 0/60 | 1/89 | 2/89 |
| Acute pulmonary oedemaRespiratory, thoracic and mediastinal disorders | 1/87 | 0/60 | 0/89 | 2/89 |
| Cardiac arrestCardiac disorders | 0/87 | 1/60 | 1/89 | 1/89 |
| Medical device complicationGeneral disorders | 0/87 | 1/60 | 0/89 | 1/89 |
| Medical device discomfortGeneral disorders | 0/87 | 1/60 | 0/89 | 0/89 |
| Event | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg |
|---|---|---|---|---|
| ConstipationGastrointestinal disorders | 11/87 | 6/60 | 9/89 | 6/89 |
| Back painMusculoskeletal and connective tissue disorders | 0/87 | 7/60 | 5/89 | 4/89 |
| DiarrhoeaGastrointestinal disorders | 8/87 | 2/60 | 2/89 | 4/89 |
| Urinary tract infectionInfections and infestations | 8/87 | 4/60 | 8/89 | 4/89 |
| NauseaGastrointestinal disorders | 7/87 | 4/60 | 7/89 | 2/89 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/87 | 3/60 | 6/89 | 5/89 |
| HypertensionVascular disorders | 3/87 | 4/60 | 5/89 | 4/89 |
| Procedural painInjury, poisoning and procedural complications | 5/87 | 1/60 | 5/89 | 2/89 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 5/87 | 0/60 | 0/89 | 2/89 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/87 | 3/60 | 5/89 | 2/89 |
| Age, Continuous(years) | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg | Total |
|---|---|---|---|---|---|
| Mean | 76.0 ± 8.6 | 76.6 ± 10.3 | 75.8 ± 10.1 | 76.7 ± 9.5 | 76.3 ± 9.5 |
| Age, Customized(Participants) | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg | Total |
|---|---|---|---|---|---|
| < 65 years | 10 | 8 | 17 | 11 | 46 |
| ≥ 65 years | 79 | 52 | 76 | 79 | 286 |
| Sex: Female, Male(Participants) | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg | Total |
|---|---|---|---|---|---|
| Female | 67 | 42 | 64 | 55 | 228 |
| Male | 22 | 18 | 29 | 35 | 104 |
| Race/Ethnicity, Customized(Participants) | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg | Total |
|---|---|---|---|---|---|
| White | 77 | 52 | 81 | 70 | 280 |
| Black or African American | 0 | 0 | 0 | 1 | 1 |
| Hispanic or Latino | 0 | 1 | 1 | 0 | 2 |
| Asian | 12 | 7 | 11 | 19 | 49 |
| Randomization Stratification(Participants) | Placebo | Romosozumab 70 mg | Romosozumab 140 mg | Romosozumab 210 mg | Total |
|---|---|---|---|---|---|
| Intertrochanteric, SHS and 55-75 years | 13 | 9 | 14 | 14 | 50 |
| Intertrochanteric, SHS and ≥ 76 years | 16 | 11 | 16 | 16 | 59 |
| Intertrochanteric, IM Nail and 55-75 years | 15 | 10 | 17 | 16 | 58 |
| Intertrochanteric, IM Nail and ≥ 76 years | 33 | 22 | 34 | 33 | 122 |
| Displaced femoral neck and SHS | 3 | 2 | 3 | 3 | 11 |
| Displaced femoral neck and cancellous screws | 6 | 4 | 6 | 5 | 21 |
| Undisplaced femoral neck | 3 | 2 | 3 | 3 | 11 |
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