NCT00907296 (STARTT) is a Phase 2 clinical trial of Romosozumab in Fracture Healing, sponsored by Amgen.

Who is sponsoring NCT00907296?

NCT00907296 is sponsored by Amgen.

What drugs are being tested in NCT00907296?

Interventions in NCT00907296: Romosozumab, Placebo.

What condition does NCT00907296 study?

NCT00907296 studies Fracture Healing.

Is NCT00907296 still recruiting?

NCT00907296 is currently completed. Last updated 22 September 2022.

Are results published for NCT00907296?

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

Last reviewed 2022-09-22 · How we verify

NCT00907296: STARTT

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

Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing

Completed Phase 2 Results posted Last updated 22 September 2022

What this trial tests

Phase 2 trial testing Romosozumab in Fracture Healing in 402 participants. Completed in 10 May 2013.

Timeline

2 September 2009

Primary endpoint
6 March 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	402
Start date	2 September 2009
Primary completion	6 March 2012
Estimated completion	10 May 2013
Sites	103 locations across Hong Kong, Italy, Poland, Denmark, New Zealand, Russia, Estonia, Mexico

Drugs / interventions tested

Romosozumab (romosozumab) — full drug profile →
Placebo

Conditions studied

Fracture Healing — all drugs for Fracture Healing →

Sponsor

Amgen — full company profile →

Who can join

Adults 18 to 85, 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.

Time to Radiographic Healing Primary · 52 weeks

Time to radiographic healing was defined as the time from intramedullary (IM) nailing to the first occurrence of bridging of 3 out of 4 cortices. Radiographic fracture healing was determined by a panel of independent reviewers (orthopedic/trauma surgeons and radiologists) 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.

Group	Value	95% CI
Placebo	16.4	14.6 – 18.0
Romosozumab 70 mg: 2 Doses	18.6	14.0 – 24.4
Romosozumab 70 mg: 3 Doses	18.3	13.0 – 21.0
Romosozumab 70 mg: 4 Doses	18.2	13.7 – 20.7
Romosozumab 140 mg: 2 Doses	17.8	12.6 – 22.9
Romosozumab 140 mg: 3 Doses	18.1	13.1 – 20.7
Romosozumab 140 mg: 4 Doses	17.0	12.7 – 21.4
Romosozumab 210 mg: 2 Doses	14.4	12.6 – 17.0
Romosozumab 210 mg: 3 Doses	15.4	13.3 – 17.4
Romosozumab 210 mg: 4 Doses	16.4	14.4 – 18.6

Change From Week 8 in Short Form (36) Health Survey Physical Functioning Domain Secondary · Week 8 and weeks 12, 16, 20, 24, 36, and 52

The Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2, is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical functioning domain includes 10 questions that assess limitations in physical activities because of health problems. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. The range of S

Week 12

Group	Value	95% CI
Placebo	5.77	± 9.90
Romosozumab 70 mg: 2 Doses	6.31	± 6.84
Romosozumab 70 mg: 3 Doses	5.67	± 8.60
Romosozumab 70 mg: 4 Doses	5.04	± 9.01
Romosozumab 140 mg: 2 Doses	4.28	± 8.22
Romosozumab 140 mg: 3 Doses	7.08	± 8.06
Romosozumab 140 mg: 4 Doses	3.63	± 9.30
Romosozumab 210 mg: 2 Doses	3.65	± 9.06
Romosozumab 210 mg: 3 Doses	7.33	± 7.99
Romosozumab 210 mg: 4 Doses	5.64	± 6.67

Week 16

Group	Value	95% CI
Placebo	9.64	± 10.36
Romosozumab 70 mg: 2 Doses	9.83	± 7.24
Romosozumab 70 mg: 3 Doses	9.19	± 11.30
Romosozumab 70 mg: 4 Doses	9.28	± 11.14
Romosozumab 140 mg: 2 Doses	8.89	± 10.71
Romosozumab 140 mg: 3 Doses	11.18	± 9.23
Romosozumab 140 mg: 4 Doses	8.78	± 11.34
Romosozumab 210 mg: 2 Doses	9.23	± 9.59
Romosozumab 210 mg: 3 Doses	9.50	± 9.01
Romosozumab 210 mg: 4 Doses	9.01	± 10.41

Week 20

Group	Value	95% CI
Placebo	13.20	± 12.25
Romosozumab 70 mg: 2 Doses	14.53	± 9.69
Romosozumab 70 mg: 3 Doses	10.45	± 11.66
Romosozumab 70 mg: 4 Doses	13.50	± 12.02
Romosozumab 140 mg: 2 Doses	12.13	± 10.88
Romosozumab 140 mg: 3 Doses	14.77	± 13.52
Romosozumab 140 mg: 4 Doses	12.44	± 11.97
Romosozumab 210 mg: 2 Doses	12.61	± 10.88
Romosozumab 210 mg: 3 Doses	12.50	± 10.76
Romosozumab 210 mg: 4 Doses	11.05	± 11.56

Week 24

Group	Value	95% CI
Placebo	15.87	± 11.55
Romosozumab 70 mg: 2 Doses	15.07	± 9.31
Romosozumab 70 mg: 3 Doses	10.34	± 13.31
Romosozumab 70 mg: 4 Doses	15.90	± 11.26
Romosozumab 140 mg: 2 Doses	14.57	± 10.34
Romosozumab 140 mg: 3 Doses	16.84	± 12.70
Romosozumab 140 mg: 4 Doses	11.79	± 17.64
Romosozumab 210 mg: 2 Doses	13.05	± 10.99
Romosozumab 210 mg: 3 Doses	13.05	± 10.25
Romosozumab 210 mg: 4 Doses	12.38	± 14.04

Week 36

Group	Value	95% CI
Placebo	19.57	± 11.60
Romosozumab 70 mg: 2 Doses	20.96	± 11.68
Romosozumab 70 mg: 3 Doses	11.48	± 17.84
Romosozumab 70 mg: 4 Doses	17.23	± 10.15
Romosozumab 140 mg: 2 Doses	17.61	± 11.03
Romosozumab 140 mg: 3 Doses	19.43	± 12.83
Romosozumab 140 mg: 4 Doses	15.70	± 19.03
Romosozumab 210 mg: 2 Doses	15.01	± 11.23
Romosozumab 210 mg: 3 Doses	17.47	± 14.34
Romosozumab 210 mg: 4 Doses	15.22	± 15.20

Week 52

Group	Value	95% CI
Placebo	20.74	± 11.96
Romosozumab 70 mg: 2 Doses	23.47	± 11.55
Romosozumab 70 mg: 3 Doses	13.63	± 19.04
Romosozumab 70 mg: 4 Doses	19.02	± 10.80
Romosozumab 140 mg: 2 Doses	19.63	± 12.17
Romosozumab 140 mg: 3 Doses	24.80	± 11.24
Romosozumab 140 mg: 4 Doses	17.19	± 15.51
Romosozumab 210 mg: 2 Doses	15.50	± 13.17
Romosozumab 210 mg: 3 Doses	18.29	± 14.94
Romosozumab 210 mg: 4 Doses	15.44	± 17.15

Number of Participants With Unplanned Revision Surgeries Secondary · 52 weeks

Group	Value	95% CI
Placebo	8
Romosozumab 70 mg: 2 Doses	1
Romosozumab 70 mg: 3 Doses	3
Romosozumab 70 mg: 4 Doses	3
Romosozumab 140 mg: 2 Doses	1
Romosozumab 140 mg: 3 Doses	0
Romosozumab 140 mg: 4 Doses	0
Romosozumab 210 mg: 2 Doses	0
Romosozumab 210 mg: 3 Doses	1
Romosozumab 210 mg: 4 Doses	1

Time to Clinical Healing Secondary · 52 weeks

Time to clinical healing was defined as the time from the IM nailing surgery date to the first date that both the score for ability to bear weight on the fractured limb and the score for absence of pain at the fracture site were equal to 6. The score for the ability to bear weight on the fractured limb was based on the ability to stand on affected leg without assistive device and the ability to walk without assistive device. The score ranges from 0 (unable to bear full body weight on the fractured limb) to 6 (able to bear full body weight on the fractured limb). Absence of pain at the fractur

Group	Value	95% CI
Placebo	18.4	16.6 – 20.4
Romosozumab 70 mg: 2 Doses	21.4	15.7 – 28.6
Romosozumab 70 mg: 3 Doses	18.3	14.4 – 22.4
Romosozumab 70 mg: 4 Doses	17.1	14.4 – 21.0
Romosozumab 140 mg: 2 Doses	20.8	12.6 – 28.0
Romosozumab 140 mg: 3 Doses	22.3	15.0 – 24.3
Romosozumab 140 mg: 4 Doses	15.0	12.6 – 17.0
Romosozumab 210 mg: 2 Doses	16.3	12.4 – 21.0
Romosozumab 210 mg: 3 Doses	14.6	12.9 – 18.6
Romosozumab 210 mg: 4 Doses	17.6	14.9 – 19.7

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: 10/100 (10%)

Deaths: —

Romosozumab 70 mg: 2 Doses

Serious: 4/34 (12%)

Deaths: —

Romosozumab 70 mg: 3 Doses

Serious: 2/34 (6%)

Deaths: —

Romosozumab 70 mg: 4 Doses

Serious: 3/32 (9%)

Deaths: —

Romosozumab 140 mg: 2 Doses

Serious: 3/33 (9%)

Deaths: —

Romosozumab 140 mg: 3 Doses

Serious: 4/32 (13%)

Deaths: —

Romosozumab 140 mg: 4 Doses

Serious: 2/31 (6%)

Deaths: —

Romosozumab 210 mg: 2 Doses

Serious: 3/32 (9%)

Deaths: —

Romosozumab 210 mg: 3 Doses

Serious: 3/30 (10%)

Deaths: —

Romosozumab 210 mg: 4 Doses

Serious: 0/35 (0%)

Deaths: —

Serious adverse events (40 terms)

Reaction	System	Placebo	Romosozumab 70 mg: 2 Doses	Romosozumab 70 mg: 3 Doses	Romosozumab 70 mg: 4 Doses	Romosozumab 140 mg: 2 Doses	Romosozumab 140 mg: 3 Doses	Romosozumab 140 mg: 4 Doses	Romosozumab 210 mg: 2 Doses	Romosozumab 210 mg: 3 Doses	Romosozumab 210 mg: 4 Doses
Wound	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—
Device breakage	General disorders	—	—	—	—	—	—	—	—	—	—
Inflammation	General disorders	—	—	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Localised infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Malaria	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Post procedural infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Wound infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Bone fissure	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Fracture displacement	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Loss of anatomical alignment after fracture reduction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Lower limb fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Ulna fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Oxygen saturation decreased	Investigations	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—

Other adverse events (26 terms — click to expand)

Reaction	System	Placebo	Romosozumab 70 mg: 2 Doses	Romosozumab 70 mg: 3 Doses	Romosozumab 70 mg: 4 Doses	Romosozumab 140 mg: 2 Doses	Romosozumab 140 mg: 3 Doses	Romosozumab 140 mg: 4 Doses	Romosozumab 210 mg: 2 Doses	Romosozumab 210 mg: 3 Doses	Romosozumab 210 mg: 4 Doses
Pain	General disorders	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Medical device discomfort	General disorders	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Limb injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Depressed mood	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Blister	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Wound, Abdominal pain upper, Chest pain, Chills, Device breakage, Inflammation, Malaise, Oedema peripheral.

Data from ClinicalTrials.gov NCT00907296 adverse events section.

Sponsor's own description

The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).

Publications & conference data

7 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
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
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
Anti‐sclerostin antibodies for the treatment of osteoporosis
Pundole X, Lopez‐Olivo M, Suarez‐Almazor M, Lu H. · · 2017

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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 NCT00907296 (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: 22 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/NCT00907296.

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

NCT00907296: STARTT

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 (40 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