NCT01081678 (STARTT-Hip) is a Phase 2 clinical trial of Romosozumab in Fracture Healing, sponsored by Amgen.

Who is sponsoring NCT01081678?

NCT01081678 is sponsored by Amgen.

What drugs are being tested in NCT01081678?

Interventions in NCT01081678: Placebo, Romosozumab.

What condition does NCT01081678 study?

NCT01081678 studies Fracture Healing.

Is NCT01081678 still recruiting?

NCT01081678 is currently completed. Last updated 21 September 2022.

Are results published for NCT01081678?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-09-21 · How we verify

NCT01081678: STARTT-Hip

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study To Assess FRacTure Healing With SclerosTin Antibody - Hip

Completed Phase 2 Results posted Last updated 21 September 2022

What this trial tests

Phase 2 trial testing Placebo in Fracture Healing in 332 participants. Completed in 10 May 2013.

Timeline

20 June 2010

Primary endpoint
30 June 2012

10 May 2013

Quick facts

Lead sponsor	Amgen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	332
Start date	20 June 2010
Primary completion	30 June 2012
Estimated completion	10 May 2013
Sites	99 locations across Hong Kong, Italy, Finland, Poland, Denmark, New Zealand, Netherlands, Belgium

Drugs / interventions tested

Placebo
Romosozumab (romosozumab) — full drug profile →

Conditions studied

Fracture Healing — all drugs for Fracture Healing →

Sponsor

Amgen — full company profile →

Who can join

Adults 55 to 95, any sex, with Fracture Healing. 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.

Timed-Up-and-Go (TUG) Over Week 6 Through Week 20 Primary · 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

Week 6

Group	Value	95% CI
Placebo	54.1	44.4 – 66.0
Romosozumab 70 mg	41.0	32.4 – 51.9
Romosozumab 140 mg	47.2	38.9 – 57.4
Romosozumab 210 mg	53.3	43.8 – 64.8

Week 12

Group	Value	95% CI
Placebo	29.8	25.3 – 35.2
Romosozumab 70 mg	27.6	22.7 – 33.5
Romosozumab 140 mg	30.0	25.6 – 35.2
Romosozumab 210 mg	36.1	30.7 – 42.5

Week 16

Group	Value	95% CI
Placebo	26.2	22.2 – 30.8
Romosozumab 70 mg	23.3	19.2 – 28.3
Romosozumab 140 mg	26.9	23.0 – 31.6
Romosozumab 210 mg	31.8	27.1 – 37.4

Week 20

Group	Value	95% CI
Placebo	23.8	20.3 – 28.0
Romosozumab 70 mg	21.9	18.1 – 26.6
Romosozumab 140 mg	22.9	19.5 – 26.8
Romosozumab 210 mg	29.1	24.8 – 34.2

Timed-Up-and-Go (TUG) at Each Visit Secondary · 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

Week 2

Group	Value	95% CI
Placebo	132.3	111.0 – 153.6
Romosozumab 70 mg	119.3	94.2 – 144.4
Romosozumab 140 mg	121.7	101.0 – 142.5
Romosozumab 210 mg	129.8	108.9 – 150.7

Week 6

Group	Value	95% CI
Placebo	92.4	74.9 – 109.9
Romosozumab 70 mg	69.5	48.6 – 90.4
Romosozumab 140 mg	80.3	63.1 – 97.5
Romosozumab 210 mg	86.7	69.3 – 104.0

Week 12

Group	Value	95% CI
Placebo	47.4	37.6 – 57.1
Romosozumab 70 mg	39.1	27.4 – 50.7
Romosozumab 140 mg	44.6	35.1 – 54.1
Romosozumab 210 mg	56.3	46.6 – 65.9

Week 16

Group	Value	95% CI
Placebo	43.1	34.1 – 52.1
Romosozumab 70 mg	31.6	20.9 – 42.4
Romosozumab 140 mg	39.7	30.9 – 48.6
Romosozumab 210 mg	50.1	41.2 – 59.1

Week 20

Group	Value	95% CI
Placebo	36.4	28.3 – 44.6
Romosozumab 70 mg	31.0	21.2 – 40.7
Romosozumab 140 mg	35.1	27.1 – 43.1
Romosozumab 210 mg	45.6	37.5 – 53.8

Week 24

Group	Value	95% CI
Placebo	33.3	25.8 – 40.7
Romosozumab 70 mg	28.9	20.1 – 37.8
Romosozumab 140 mg	31.7	24.4 – 39.0
Romosozumab 210 mg	40.9	33.5 – 48.4

Week 36

Group	Value	95% CI
Placebo	32.4	25.1 – 39.7
Romosozumab 70 mg	26.3	17.5 – 35.0
Romosozumab 140 mg	29.8	22.5 – 37.0
Romosozumab 210 mg	38.7	31.3 – 46.0

Week 52

Group	Value	95% CI
Placebo	28.7	22.2 – 35.1
Romosozumab 70 mg	22.8	15.2 – 30.5
Romosozumab 140 mg	28.8	22.5 – 35.2
Romosozumab 210 mg	36.3	29.8 – 42.7

Time to Radiographic Healing Secondary · 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 w

Group	Value	95% CI
Placebo	16.4	15.3 – 20.1
Romosozumab 70 mg	16.9	12.9 – 20.3
Romosozumab 140 mg	16.6	13.3 – 17.1
Romosozumab 210 mg	16.9	13.3 – 20.9

Radiographic Union Scale for Hip (RUSH) Score At Each Visit Secondary · 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).

Week 2

Group	Value	95% CI
Placebo	12.1	± 3.3
Romosozumab 70 mg	12.7	± 3.5
Romosozumab 140 mg	12.1	± 3.4
Romosozumab 210 mg	12.0	± 3.1

Week 6

Group	Value	95% CI
Placebo	18.1	± 3.6
Romosozumab 70 mg	18.0	± 4.2
Romosozumab 140 mg	18.4	± 3.4
Romosozumab 210 mg	18.3	± 4.0

Week 12

Group	Value	95% CI
Placebo	23.3	± 4.6
Romosozumab 70 mg	22.8	± 4.8
Romosozumab 140 mg	22.9	± 4.8
Romosozumab 210 mg	22.3	± 5.3

Week 16

Group	Value	95% CI
Placebo	25.6	± 4.3
Romosozumab 70 mg	25.7	± 4.5
Romosozumab 140 mg	25.5	± 5.0
Romosozumab 210 mg	25.5	± 4.7

Week 20

Group	Value	95% CI
Placebo	26.8	± 4.1
Romosozumab 70 mg	27.3	± 4.1
Romosozumab 140 mg	27.4	± 4.0
Romosozumab 210 mg	26.4	± 4.6

Week 24

Group	Value	95% CI
Placebo	27.8	± 3.4
Romosozumab 70 mg	27.8	± 3.9
Romosozumab 140 mg	28.3	± 3.5
Romosozumab 210 mg	27.3	± 3.9

Week 36

Group	Value	95% CI
Placebo	28.7	± 2.6
Romosozumab 70 mg	28.3	± 3.6
Romosozumab 140 mg	29.1	± 2.1
Romosozumab 210 mg	28.2	± 3.5

Week 52

Group	Value	95% CI
Placebo	29.4	± 2.0
Romosozumab 70 mg	28.5	± 3.8
Romosozumab 140 mg	29.6	± 1.8
Romosozumab 210 mg	28.7	± 3.3

Harris Hip Score At Each Visit Secondary · 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

Week 2

Group	Value	95% CI
Placebo	46.6	43.1 – 50.1
Romosozumab 70 mg	47.7	43.6 – 51.9
Romosozumab 140 mg	47.3	43.9 – 50.8
Romosozumab 210 mg	46.5	43.1 – 50.0

Week 6

Group	Value	95% CI
Placebo	58.6	55.1 – 62.1
Romosozumab 70 mg	62.5	58.3 – 66.7
Romosozumab 140 mg	61.6	58.1 – 65.0
Romosozumab 210 mg	59.5	55.9 – 63.0

Week 12

Group	Value	95% CI
Placebo	71.2	67.9 – 74.5
Romosozumab 70 mg	70.9	67.0 – 74.9
Romosozumab 140 mg	71.7	68.3 – 75.1
Romosozumab 210 mg	69.6	66.2 – 72.9

Week 16

Group	Value	95% CI
Placebo	74.1	70.8 – 77.4
Romosozumab 70 mg	76.5	72.6 – 80.5
Romosozumab 140 mg	76.1	72.7 – 79.4
Romosozumab 210 mg	72.8	69.4 – 76.2

Week 20

Group	Value	95% CI
Placebo	76.2	73.0 – 79.3
Romosozumab 70 mg	80.2	76.4 – 83.9
Romosozumab 140 mg	80.5	77.4 – 83.6
Romosozumab 210 mg	77.5	74.3 – 80.7

Week 24

Group	Value	95% CI
Placebo	79.0	76.2 – 81.8
Romosozumab 70 mg	80.3	76.8 – 83.7
Romosozumab 140 mg	83.0	80.1 – 85.8
Romosozumab 210 mg	80.1	77.2 – 83.0

Week 36

Group	Value	95% CI
Placebo	80.3	77.0 – 83.6
Romosozumab 70 mg	82.0	78.1 – 85.8
Romosozumab 140 mg	86.8	83.5 – 90.2
Romosozumab 210 mg	83.6	80.2 – 86.9

Week 52

Group	Value	95% CI
Placebo	84.3	81.3 – 87.4
Romosozumab 70 mg	86.7	83.0 – 90.3
Romosozumab 140 mg	89.0	85.9 – 92.1
Romosozumab 210 mg	83.8	80.7 – 86.9

Hip Pain Score at Each Visit Secondary · 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.

Week 2

Group	Value	95% CI
Placebo	34.3	28.2 – 40.4
Romosozumab 70 mg	33.1	25.9 – 40.3
Romosozumab 140 mg	40.3	34.4 – 46.2
Romosozumab 210 mg	43.0	37.1 – 48.9

Week 6

Group	Value	95% CI
Placebo	26.3	20.8 – 31.7
Romosozumab 70 mg	19.5	13.1 – 26.0
Romosozumab 140 mg	25.1	19.7 – 30.4
Romosozumab 210 mg	27.5	22.1 – 32.9

Week 12

Group	Value	95% CI
Placebo	19.4	14.1 – 24.8
Romosozumab 70 mg	17.8	11.5 – 24.1
Romosozumab 140 mg	17.5	12.1 – 22.8
Romosozumab 210 mg	23.7	18.3 – 29.0

Week 16

Group	Value	95% CI
Placebo	18.1	13.0 – 23.3
Romosozumab 70 mg	13.5	7.4 – 19.6
Romosozumab 140 mg	16.8	11.8 – 21.8
Romosozumab 210 mg	17.4	12.2 – 22.5

Week 20

Group	Value	95% CI
Placebo	15.8	11.2 – 20.4
Romosozumab 70 mg	9.2	3.8 – 14.7
Romosozumab 140 mg	14.0	9.5 – 18.5
Romosozumab 210 mg	15.0	10.5 – 19.6

Week 24

Group	Value	95% CI
Placebo	13.8	9.6 – 18.0
Romosozumab 70 mg	9.1	4.0 – 14.2
Romosozumab 140 mg	12.7	8.4 – 17.0
Romosozumab 210 mg	13.1	8.8 – 17.3

Week 36

Group	Value	95% CI
Placebo	14.3	9.6 – 19.0
Romosozumab 70 mg	10.9	5.4 – 16.4
Romosozumab 140 mg	11.6	6.8 – 16.3
Romosozumab 210 mg	10.2	5.5 – 14.9

Week 52

Group	Value	95% CI
Placebo	13.4	9.2 – 17.7
Romosozumab 70 mg	7.2	2.1 – 12.3
Romosozumab 140 mg	9.3	5.1 – 13.5
Romosozumab 210 mg	10.4	6.2 – 14.6

Adverse events — posted to ClinicalTrials.gov

Time frame: 52 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 25/87 (29%)

Deaths: —

Romosozumab 70 mg

Serious: 9/60 (15%)

Deaths: —

Romosozumab 140 mg

Serious: 15/89 (17%)

Deaths: —

Romosozumab 210 mg

Serious: 26/89 (29%)

Deaths: —

Serious adverse events (81 terms)

Reaction	System	Placebo	Romosozumab 70 mg	Romosozumab 140 mg	Romosozumab 210 mg
Cellulitis	Infections and infestations	—	—	—	—
Postoperative wound infection	Infections and infestations	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Hip fracture	Injury, poisoning and procedural complications	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Acute coronary syndrome	Cardiac disorders	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—
Atrioventricular block	Cardiac disorders	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—
Cardiac disorder	Cardiac disorders	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—	—	—
Haemorrhage coronary artery	Cardiac disorders	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Duodenal ulcer haemorrhage	Gastrointestinal disorders	—	—	—	—
Haematemesis	Gastrointestinal disorders	—	—	—	—
Intestinal haemorrhage	Gastrointestinal disorders	—	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—	—
Death	General disorders	—	—	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	Placebo	Romosozumab 70 mg	Romosozumab 140 mg	Romosozumab 210 mg
Constipation	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—

Most-reported serious reactions: Cellulitis, Postoperative wound infection, Acute myocardial infarction, Pneumonia, Hip fracture, Osteoarthritis, Acute pulmonary oedema, Anaemia.

Data from ClinicalTrials.gov NCT01081678 adverse events section.

Sponsor's own description

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.

Publications & conference data

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

Bone regeneration strategies: Engineered scaffolds, bioactive molecules and stem cells current stage and future perspectives.
Ho-Shui-Ling A, Bolander J, Rustom LE, Johnson AW, et al · · 2018 · cited 606× · PMID 30036727 · DOI 10.1016/j.biomaterials.2018.07.017
Fracture healing physiology and the quest for therapies for delayed healing and nonunion.
Kostenuik P, Mirza FM. · · 2017 · cited 120× · PMID 27743449 · DOI 10.1002/jor.23460
Role of sclerostin in bone and cartilage and its potential as a therapeutic target in bone diseases.
Lewiecki EM. · · 2014 · cited 112× · PMID 24688605 · DOI 10.1177/1759720x13510479
A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures.
Schemitsch EH, Miclau T, Karachalios T, Nowak LL, et al · · 2020 · cited 61× · PMID 31977817 · DOI 10.2106/jbjs.19.00790
Advances in regenerative orthopedics.
Evans CH. · · 2013 · cited 56× · PMID 24182709 · DOI 10.1016/j.mayocp.2013.04.027
Sclerostin Antibody Therapy for the Treatment of Osteoporosis: Clinical Prospects and Challenges.
MacNabb C, Patton D, Hayes JS. · · 2016 · cited 44× · PMID 27313945 · DOI 10.1155/2016/6217286
Sclerostin inhibition: a novel therapeutic approach in the treatment of osteoporosis.
Shah AD, Shoback D, Lewiecki EM. · · 2015 · cited 40× · PMID 26082665 · DOI 10.2147/ijwh.s73244
Treatment effects, adverse outcomes and cardiovascular safety of romosozumab - Existing worldwide data: A systematic review and meta-analysis.
Wong RMY, Wong PY, Liu C, Wong HY, et al · · 2024 · cited 8× · PMID 39189010 · DOI 10.1016/j.jot.2024.07.011

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01081678 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 21 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01081678.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01081678: STARTT-Hip

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (81 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Romosozumab

Other recruiting trials for Fracture Healing

Other Amgen trials

Verify against primary sources