NCT03118570 (Asteroid) is a Phase 2 clinical trial of setrusumab in Osteogenesis Imperfecta, Type I, sponsored by Ultragenyx Pharmaceutical Inc.

Who is sponsoring NCT03118570?

NCT03118570 is sponsored by Ultragenyx Pharmaceutical Inc.

What drugs are being tested in NCT03118570?

Interventions in NCT03118570: setrusumab, Calcium, Vitamin D, zoledronic acid (optional).

What condition does NCT03118570 study?

NCT03118570 studies Osteogenesis Imperfecta, Type I, Osteogenesis Imperfecta Type III, Osteogenesis Imperfecta Type IV.

Is NCT03118570 still recruiting?

NCT03118570 is currently completed. Last updated 5 July 2023.

Are results published for NCT03118570?

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

Last reviewed 2023-07-05 · How we verify

NCT03118570: Asteroid

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

A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804

Completed Phase 2 Results posted Last updated 5 July 2023

What this trial tests

Phase 2 trial testing setrusumab in Osteogenesis Imperfecta, Type I in 112 participants. Completed in 12 November 2020.

Timeline

11 September 2017

Primary endpoint
1 October 2019

12 November 2020

Quick facts

Lead sponsor	Ultragenyx Pharmaceutical Inc
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	112
Start date	11 September 2017
Primary completion	1 October 2019
Estimated completion	12 November 2020
Sites	25 locations across Denmark, France, United Kingdom, Canada, United States

Drugs / interventions tested

setrusumab — full drug profile →
Calcium (CALCIUM) — full drug profile →
Vitamin D
zoledronic acid (optional) — full drug profile →

Conditions studied

Osteogenesis Imperfecta, Type I — all drugs for Osteogenesis Imperfecta, Type I →
Osteogenesis Imperfecta Type III — all drugs for Osteogenesis Imperfecta Type III →
Osteogenesis Imperfecta Type IV — all drugs for Osteogenesis Imperfecta Type IV →

Sponsor

Ultragenyx Pharmaceutical Inc — full company profile →

Who can join

Adults 18 to 75, any sex, with Osteogenesis Imperfecta, Type I or Osteogenesis Imperfecta Type III. 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.

Change From Baseline in Radial Trabecular Volumetric Bone Mineral Density (Tr vBMD) at Month 12 Primary · Baseline, Month 12 (end of treatment [EOT])

Assessed by high resolution peripheral quantitative computed tomography (HRpQCT). HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presents the ratio of the means between the visit and Baseline from analysis of covariance (ANCOVA).

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	1.004	0.987 – 1.021
Setrusumab 8 mg/kg (Blinded)	0.993	0.975 – 1.012
Setrusumab 2 mg/kg (Blinded)	0.992	0.974 – 1.011

Change From Baseline in Radial Bone Strength (Failure Load) at Month 12 Primary · Baseline, Month 12 (EOT)

Assessed by finite element analysis (FEA) of models generated from HRpQCT images of the distal radius.

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	61.25	± 21.669
Setrusumab 8 mg/kg (Blinded)	32.25	± 24.342
Setrusumab 2 mg/kg (Blinded)	8.86	± 23.200

Change From Baseline in Radial Bone Strength (Stiffness) at Month 12 Primary · Baseline, Month 12 (EOT)

Assessed by FEA of models generated from HRpQCT images of the distal radius.

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	1638.70	± 625.808
Setrusumab 8 mg/kg (Blinded)	1422.00	± 703.275
Setrusumab 2 mg/kg (Blinded)	209.89	± 671.777

Change From Baseline in Radial and Tibial Tr VBMD Over Time: Full Analysis Set Secondary · Baseline, Months 6, 12 (EOT), 18, 24

Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA.

Radial: Month 6

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	1.007	0.993 – 1.021
Setrusumab 8 mg/kg (Blinded)	1.000	0.986 – 1.015
Setrusumab 2 mg/kg (Blinded)	0.998	0.984 – 1.013

Radial: Month 12

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	1.004	0.987 – 1.021
Setrusumab 8 mg/kg (Blinded)	0.993	0.975 – 1.012
Setrusumab 2 mg/kg (Blinded)	0.992	0.974 – 1.011

Radial: Month 18

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	1.002	0.984 – 1.020
Setrusumab 8 mg/kg (Blinded)	0.992	0.973 – 1.013
Setrusumab 2 mg/kg (Blinded)	0.979	0.962 – 0.997

Radial: Month 24

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	0.997	0.972 – 1.023
Setrusumab 8 mg/kg (Blinded)	0.998	0.970 – 1.027
Setrusumab 2 mg/kg (Blinded)	0.979	0.951 – 1.008

Tibial: Month 6

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	1.004	0.986 – 1.022
Setrusumab 8 mg/kg (Blinded)	1.016	0.996 – 1.036
Setrusumab 2 mg/kg (Blinded)	0.990	0.969 – 1.012

Tibial: Month 12

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	0.991	0.940 – 1.046
Setrusumab 8 mg/kg (Blinded)	1.018	0.955 – 1.086
Setrusumab 2 mg/kg (Blinded)	0.973	0.909 – 1.042

Tibial: Month 18

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	0.989	0.945 – 1.035
Setrusumab 8 mg/kg (Blinded)	1.042	0.985 – 1.102
Setrusumab 2 mg/kg (Blinded)	0.983	0.933 – 1.036

Tibial: Month 24

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	1.000	0.949 – 1.054
Setrusumab 8 mg/kg (Blinded)	1.062	0.995 – 1.133
Setrusumab 2 mg/kg (Blinded)	1.017	0.949 – 1.090

Changes From Baseline in Radial and Tibial Tr VBMD at Months 6 and 12: Open-Label Arm Secondary · Baseline, Months 6, 12 (EOT)

Radial: Month 6

Group	Value	95% CI
Setrusumab 20 mg/kg (Open-Label)	0.994	0.972 – 1.017

Radial: Month 12

Group	Value	95% CI
Setrusumab 20 mg/kg (Open-Label)	1.011	0.986 – 1.036

Tibial: Month 6

Group	Value	95% CI
Setrusumab 20 mg/kg (Open-Label)	1.013	0.991 – 1.035

Tibial: Month 12

Group	Value	95% CI
Setrusumab 20 mg/kg (Open-Label)	1.035	0.975 – 1.099

Changes From Baseline in Radial and Tibial Bone Strength (Failure Load) Over Time: Full Analysis Set Secondary · Baseline, Months 6, 12 (EOT), 18, 24

Assessed by FEA of models generated from HRpQCT images of the distal radius.

Radial: Month 6

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	31.22	-1.80 – 64.23
Setrusumab 8 mg/kg (Blinded)	39.95	6.63 – 73.27
Setrusumab 2 mg/kg (Blinded)	-3.28	-36.57 – 30.00

Radial: Month 12

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	61.25	18.03 – 104.46
Setrusumab 8 mg/kg (Blinded)	32.25	-16.30 – 80.80
Setrusumab 2 mg/kg (Blinded)	8.86	-37.41 – 55.13

Radial: Month 18

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	50.39	19.11 – 81.68
Setrusumab 8 mg/kg (Blinded)	43.11	6.79 – 79.42
Setrusumab 2 mg/kg (Blinded)	-10.53	-41.86 – 20.80

Radial: Month 24

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	-19.59	-72.66 – 33.47
Setrusumab 8 mg/kg (Blinded)	45.03	-14.40 – 104.47
Setrusumab 2 mg/kg (Blinded)	-50.65	-108.69 – 7.39

Tibial: Month 6

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	46.00	-24.91 – 116.92
Setrusumab 8 mg/kg (Blinded)	45.91	-28.16 – 119.98
Setrusumab 2 mg/kg (Blinded)	-65.33	-146.39 – 15.72

Tibial: Month 12

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	76.15	-11.23 – 163.54
Setrusumab 8 mg/kg (Blinded)	60.20	-42.63 – 163.04
Setrusumab 2 mg/kg (Blinded)	-65.96	-175.43 – 43.51

Tibial: Month 18

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	50.69	-34.55 – 135.93
Setrusumab 8 mg/kg (Blinded)	88.33	-13.67 – 190.32
Setrusumab 2 mg/kg (Blinded)	-49.50	-144.93 – 45.94

Tibial: Month 24

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	-24.75	-126.76 – 77.27
Setrusumab 8 mg/kg (Blinded)	41.37	-86.68 – 169.43
Setrusumab 2 mg/kg (Blinded)	-74.94	-208.22 – 58.34

Changes From Baseline in Radial and Tibial Bone Strength (Failure Load) at Months 6 and 12: Open-Label Arm Secondary · Baseline, Months 6, 12 (EOT)

Assessed by FEA of models generated from HRpQCT images of the distal radius.

Radial: Month 6

Group	Value	95% CI
Setrusumab 20 mg/kg (Open-Label)	110.16	61.30 – 159.01

Radial: Month 12

Group	Value	95% CI
Setrusumab 20 mg/kg (Open-Label)	88.32	28.55 – 148.09

Tibial: Month 6

Group	Value	95% CI
Setrusumab 20 mg/kg (Open-Label)	69.78	-8.61 – 148.18

Tibial: Month 12

Group	Value	95% CI
Setrusumab 20 mg/kg (Open-Label)	112.92	10.76 – 215.07

Changes From Baseline in Radial and Tibial Bone Strength (Stiffness) Over Time: Full Analysis Set Secondary · Baseline, Months 6, 12 (EOT), 18, 24

Assessed by FEA of models generated from HRpQCT images of the distal radius.

Radial: Month 6

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	795.67	-34.71 – 1626.04
Setrusumab 8 mg/kg (Blinded)	1048.61	209.47 – 1887.75
Setrusumab 2 mg/kg (Blinded)	109.65	-728.52 – 947.82

Radial: Month 12

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	1638.70	390.57 – 2886.83
Setrusumab 8 mg/kg (Blinded)	1422.00	19.37 – 2824.64
Setrusumab 2 mg/kg (Blinded)	209.89	-1129.93 – 1549.71

Radial: Month 18

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	1295.98	390.54 – 2201.42
Setrusumab 8 mg/kg (Blinded)	803.50	-263.21 – 1870.21
Setrusumab 2 mg/kg (Blinded)	-215.92	-1132.78 – 700.94

Radial: Month 24

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	-625.46	-1888.53 – 637.60
Setrusumab 8 mg/kg (Blinded)	1172.45	-265.87 – 2610.76
Setrusumab 2 mg/kg (Blinded)	-1258.55	-2663.69 – 146.60

Tibial: Month 6

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	1344.84	-296.83 – 2986.52
Setrusumab 8 mg/kg (Blinded)	1051.40	-708.46 – 2811.25
Setrusumab 2 mg/kg (Blinded)	-1356.71	-3284.14 – 570.73

Tibial: Month 12

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	2326.63	221.71 – 4431.55
Setrusumab 8 mg/kg (Blinded)	1543.85	-973.70 – 4061.40
Setrusumab 2 mg/kg (Blinded)	-1428.87	-4118.78 – 1261.03

Tibial: Month 18

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	1047.16	-1070.79 – 3165.11
Setrusumab 8 mg/kg (Blinded)	1697.21	-861.80 – 4256.23
Setrusumab 2 mg/kg (Blinded)	-815.38	-3247.85 – 1617.09

Tibial: Month 24

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	-1250.69	-4131.64 – 1630.26
Setrusumab 8 mg/kg (Blinded)	622.77	-2966.46 – 4212.01
Setrusumab 2 mg/kg (Blinded)	-1844.84	-5695.04 – 2005.37

Changes From Baseline in Radial and Tibial Bone Strength (Stiffness) at Months 6 and 12: Open-Label Arm Secondary · Baseline, Months 6, 12 (EOT)

Assessed by FEA of models generated from HRpQCT images of the distal radius.

Radial: Month 6

Group	Value	95% CI
Setrusumab 20 mg/kg (Open-Label)	5056.51	3404.58 – 6708.45

Radial: Month 12

Group	Value	95% CI
Setrusumab 20 mg/kg (Open-Label)	4992.82	3056.80 – 6928.84

Tibial: Month 6

Group	Value	95% CI
Setrusumab 20 mg/kg (Open-Label)	4225.92	1840.16 – 6611.68

Tibial: Month 12

Group	Value	95% CI
Setrusumab 20 mg/kg (Open-Label)	5827.81	2601.54 – 9054.08

Percentage of Participants With at Least 1 New Fracture (Peripheral, Vertebral, Long-Bone, Any) at Month 12 Secondary · Month 12 (EOT)

Fracture assessment, confirmed by central radiographic reading, was carried out for peripheral including all major long bones, minor bone (digits, ribs) and vertebral fractures. Fractures without clinical symptoms, detected only by means of radiographic investigations, were not included in the analysis.

Peripheral

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	6.5
Setrusumab 8 mg/kg (Blinded)	17.2
Setrusumab 2 mg/kg (Blinded)	13.3

Vertebral

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	0
Setrusumab 8 mg/kg (Blinded)	0
Setrusumab 2 mg/kg (Blinded)	0

Long-Bone

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	3.2
Setrusumab 8 mg/kg (Blinded)	13.8
Setrusumab 2 mg/kg (Blinded)	3.3

Any

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	16.1
Setrusumab 8 mg/kg (Blinded)	34.5
Setrusumab 2 mg/kg (Blinded)	23.3

Change From Baseline in Lumbar, Total Body, and Femoral Neck Bone Mineral Density (BMD) T-score at Month 6 Secondary · Baseline, Month 6

BMD was evaluated by dual-energy x-ray absorptiometry (DXA). T-Score was calculated based on actual measured bone density value. T-scores are standardized scores that reflect the standard deviations (SDs) above/below the normal mean for young adults. A score of 50 indicates the population mean with a standard deviation of 10. A positive change in DXA T-score indicates an improvement in BMD.

Lumbar

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	0.273	0.142 – 0.405
Setrusumab 8 mg/kg (Blinded)	0.338	0.213 – 0.464
Setrusumab 2 mg/kg (Blinded)	0.110	-0.014 – 0.233

Total Body

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	0.072	-0.049 – 0.194
Setrusumab 8 mg/kg (Blinded)	0.071	-0.048 – 0.189
Setrusumab 2 mg/kg (Blinded)	0.122	0.009 – 0.235

Femoral Neck

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	-0.024	-0.143 – 0.095
Setrusumab 8 mg/kg (Blinded)	0.102	-0.023 – 0.226
Setrusumab 2 mg/kg (Blinded)	0.087	-0.026 – 0.199

Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD at Month 6 Secondary · Baseline, Month 6

BMD was evaluated by DXA.

Lumbar

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	4.06	2.12 – 6.00
Setrusumab 8 mg/kg (Blinded)	4.70	2.86 – 6.55
Setrusumab 2 mg/kg (Blinded)	1.58	-0.24 – 3.40

Total Body

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	0.77	-0.38 – 1.92
Setrusumab 8 mg/kg (Blinded)	0.83	-0.29 – 1.94
Setrusumab 2 mg/kg (Blinded)	1.21	0.14 – 2.28

Femoral Neck

Group	Value	95% CI
Setrusumab 20 mg/kg (Blinded)	-0.42	-2.51 – 1.68
Setrusumab 8 mg/kg (Blinded)	1.64	-0.57 – 3.84
Setrusumab 2 mg/kg (Blinded)	1.61	-0.38 – 3.59

Adverse events — posted to ClinicalTrials.gov

Time frame: Non-serious AEs: up to Month 14; Serious AEs: up to Month 24. (Average duration of exposure to placebo was 5 months and for setrusumab was 11 month plus follow-up to 24 months.). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Setrusumab 20 mg/kg (Blinded)

Serious: 4/31 (13%)

Deaths: 0/31

Setrusumab 8 mg/kg (Blinded)

Serious: 7/29 (24%)

Deaths: 0/29

Setrusumab 2 mg/kg (Blinded)

Serious: 7/30 (23%)

Deaths: 0/30

Setrusumab 20 mg/kg (Open-Label)

Serious: 5/21 (24%)

Deaths: 0/21

Placebo

Serious: 2/20 (10%)

Deaths: 0/20

Serious adverse events (41 terms)

Reaction	System	Setrusumab 20 mg/kg (Blind…	Setrusumab 8 mg/kg (Blinded)	Setrusumab 2 mg/kg (Blinded)	Setrusumab 20 mg/kg (Open-…	Placebo
Femur fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Pelvic fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Tibia fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Fibula fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Fracture of penis	Injury, poisoning and procedural complications	—	—	—	—	—
Hand fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Ilium fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Lumbar vertebral fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Radius fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Rib fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Subcutaneous haematoma	Injury, poisoning and procedural complications	—	—	—	—	—
Wound	Injury, poisoning and procedural complications	—	—	—	—	—
Scapula fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Anal abscess	Infections and infestations	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—
Joint abscess	Infections and infestations	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Wound infection	Infections and infestations	—	—	—	—	—
Pyelonephritis acute	Infections and infestations	—	—	—	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—

Other adverse events (85 terms — click to expand)

Reaction	System	Setrusumab 20 mg/kg (Blind…	Setrusumab 8 mg/kg (Blinded)	Setrusumab 2 mg/kg (Blinded)	Setrusumab 20 mg/kg (Open-…	Placebo
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—
Foot fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Tooth fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Ear infection	Infections and infestations	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—
Hand fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Joint dislocation	Injury, poisoning and procedural complications	—	—	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—	—	—
Limb injury	Injury, poisoning and procedural complications	—	—	—	—	—
Rib fracture	Injury, poisoning and procedural complications	—	—	—	—	—
International normalised ratio increased	Investigations	—	—	—	—	—
Prothrombin time prolonged	Investigations	—	—	—	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—	—
Migraine	Nervous system disorders	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—	—	—
Blepharospasm	Eye disorders	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—

Most-reported serious reactions: Femur fracture, Pelvic fracture, Tibia fracture, Ankle fracture, Fibula fracture, Fracture of penis, Hand fracture, Ilium fracture.

Data from ClinicalTrials.gov NCT03118570 adverse events section.

Sponsor's own description

The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.

Publications & conference data

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

Osteogenesis imperfecta: an update on clinical features and therapies.
Marom R, Rabenhorst BM, Morello R. · · 2020 · cited 170× · PMID 32621590 · DOI 10.1530/eje-20-0299
Targeting strategies for bone diseases: signaling pathways and clinical studies.
Xu H, Wang W, Liu X, Huang W, et al · · 2023 · cited 97× · PMID 37198232 · DOI 10.1038/s41392-023-01467-8
The evolving roles of Wnt signaling in stem cell proliferation and differentiation, the development of human diseases, and therapeutic opportunities.
Yu M, Qin K, Fan J, Zhao G, et al · · 2024 · cited 81× · PMID 38292186 · DOI 10.1016/j.gendis.2023.04.042
Osteogenesis imperfecta and therapeutics.
Morello R. · · 2018 · cited 76× · PMID 29540309 · DOI 10.1016/j.matbio.2018.03.010
Management of Osteogenesis Imperfecta.
Ralston SH, Gaston MS. · · 2019 · cited 63× · PMID 32117044 · DOI 10.3389/fendo.2019.00924
Regulation of bone homeostasis: signaling pathways and therapeutic targets.
Wu Z, Li W, Jiang K, Lin Z, et al · · 2024 · cited 42× · PMID 39049966 · DOI 10.1002/mco2.657
The Role of Sclerostin in Bone Diseases.
Vasiliadis ES, Evangelopoulos DS, Kaspiris A, Benetos IS, et al · · 2022 · cited 38× · PMID 35160258 · DOI 10.3390/jcm11030806
Setrusumab for the treatment of osteogenesis imperfecta: 12-month results from the phase 2b asteroid study.
Glorieux FH, Langdahl B, Chapurlat R, De Beur SJ, et al · · 2024 · cited 18× · PMID 39012717 · DOI 10.1093/jbmr/zjae112

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Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03118570 (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 Ultragenyx Pharmaceutical Inc
Last refreshed: 5 July 2023

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/NCT03118570.

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

NCT03118570: Asteroid

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 (41 terms)

Sponsor's own description

Publications & conference data

Related trials

Other Ultragenyx Pharmaceutical Inc trials

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