NCT01588509 is a Phase 1 clinical trial of Romosozumab in Osteoporosis, sponsored by Amgen.

Who is sponsoring NCT01588509?

NCT01588509 is sponsored by Amgen.

What drugs are being tested in NCT01588509?

Interventions in NCT01588509: Romosozumab.

What condition does NCT01588509 study?

NCT01588509 studies Osteoporosis.

Is NCT01588509 still recruiting?

NCT01588509 is currently completed. Last updated 26 March 2019.

Are results published for NCT01588509?

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

Last reviewed 2019-03-26 · How we verify

NCT01588509

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

Transition From Alendronate to Romosozumab (AMG 785)

Completed Phase 1 Results posted Last updated 26 March 2019

What this trial tests

Phase 1 trial testing Romosozumab in Osteoporosis in 60 participants. Completed in 21 November 2012.

Timeline

30 March 2012

Primary endpoint
21 November 2012

21 November 2012

Quick facts

Lead sponsor	Amgen
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	30 March 2012
Primary completion	21 November 2012
Estimated completion	21 November 2012
Sites	9 locations across United States

Drugs / interventions tested

Romosozumab (romosozumab) — full drug profile →

Conditions studied

Osteoporosis — all drugs for Osteoporosis →

Sponsor

Amgen — full company profile →

Who can join

Adults 55 to 85, female only, with Osteoporosis. 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.

Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine Primary · Baseline and day 85

Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and analyzed by a central imaging lab.

Group	Value	95% CI
Romosozumab 140 mg	2.13	± 0.64
Romosozumab 210 mg	2.08	± 0.63

Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck Secondary · Baseline and day 85

Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.

Group	Value	95% CI
Romosozumab 140 mg	2.06	± 0.59
Romosozumab 210 mg	1.92	± 0.58

Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip Secondary · Baseline and day 85

Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.

Group	Value	95% CI
Romosozumab 140 mg	1.38	± 0.34
Romosozumab 210 mg	1.40	± 0.34

Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP) Secondary · Baseline and days 4, 15, 29, 43, 57, 71, and 85

Day 4

Group	Value	95% CI
Romosozumab 140 mg	22.1263	± 3.3852
Romosozumab 210 mg	30.4935	± 4.9950

Day 15

Group	Value	95% CI
Romosozumab 140 mg	140.9970	± 15.1975
Romosozumab 210 mg	218.4994	± 22.6148

Day 29

Group	Value	95% CI
Romosozumab 140 mg	128.3936	± 17.7834
Romosozumab 210 mg	221.9954	± 23.3718

Day 43

Group	Value	95% CI
Romosozumab 140 mg	164.1654	± 17.7832
Romosozumab 210 mg	251.0495	± 23.4572

Day 57

Group	Value	95% CI
Romosozumab 140 mg	99.3682	± 14.9155
Romosozumab 210 mg	168.7689	± 17.1565

Day 71

Group	Value	95% CI
Romosozumab 140 mg	127.4051	± 14.8572
Romosozumab 210 mg	205.2619	± 23.5171

Day 85

Group	Value	95% CI
Romosozumab 140 mg	64.9103	± 10.5005
Romosozumab 210 mg	142.5601	± 20.3233

Percent Change From Baseline in Serum C-telopeptide (sCTX) Secondary · Baseline and days 4, 15, 29, 43, 57, 71, and 85

Day 4

Group	Value	95% CI
Romosozumab 140 mg	-28.2149	± 3.9352
Romosozumab 210 mg	-14.8099	± 4.6844

Day 15

Group	Value	95% CI
Romosozumab 140 mg	-28.9365	± 4.6974
Romosozumab 210 mg	-22.2800	± 5.1854

Day 29

Group	Value	95% CI
Romosozumab 140 mg	3.1008	± 8.6448
Romosozumab 210 mg	-1.8188	± 7.4121

Day 43

Group	Value	95% CI
Romosozumab 140 mg	3.4511	± 8.9913
Romosozumab 210 mg	11.0131	± 10.0244

Day 57

Group	Value	95% CI
Romosozumab 140 mg	25.7433	± 8.7440
Romosozumab 210 mg	35.7697	± 13.5346

Day 71

Group	Value	95% CI
Romosozumab 140 mg	28.4465	± 11.7345
Romosozumab 210 mg	44.3802	± 13.7159

Day 85

Group	Value	95% CI
Romosozumab 140 mg	54.0549	± 14.2140
Romosozumab 210 mg	61.1734	± 13.9874

Number of Participants With Adverse Events Secondary · From first dose of study drug up to day 85

An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events. A treatment-related adverse event (TRAE) was an adverse event assessed by the investigator as possibly related to the investigational product, indicated by a "yes" response to the question: Is there a reasonable possibility that the event may have been caused by the investigational product? A serious adverse event was defined as an adverse event that met at least 1 of the follow

All adverse events

Group	Value	95% CI
Romosozumab 140 mg	14
Romosozumab 210 mg	15

Serious adverse events

Group	Value	95% CI
Romosozumab 140 mg	0
Romosozumab 210 mg	0

AE leading to discontinuation of study drug

Group	Value	95% CI
Romosozumab 140 mg	0
Romosozumab 210 mg	0

AE leading to discontinuation from study

Group	Value	95% CI
Romosozumab 140 mg	0
Romosozumab 210 mg	0

Fatal adverse events

Group	Value	95% CI
Romosozumab 140 mg	0
Romosozumab 210 mg	0

Treatment-related adverse events

Group	Value	95% CI
Romosozumab 140 mg	3
Romosozumab 210 mg	4

Treatment-related serious adverse events

Group	Value	95% CI
Romosozumab 140 mg	0
Romosozumab 210 mg	0

TRAE leading to discontinuation of study drug

Group	Value	95% CI
Romosozumab 140 mg	0
Romosozumab 210 mg	0

Number of Participants Who Developed Anti-romosozumab Antibodies Secondary · Baseline and days 29, 57, and 85

Two validated assays were used to detect the presence of anti-romosozumab antibodies. An electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding romosozumab. Samples testing positive in the immunoassay were further tested in a competitive binding bioassay for neutralizing activity against romosozumab. If a sample was positive for binding antibodies and demonstrated neutralizing activity, the participant was defined as positive for neutralizing antibodies. Participants who developed anti-

Binding antibody positive

Group	Value	95% CI
Romosozumab 140 mg	2
Romosozumab 210 mg	2

Neutralizing antibody positive

Group	Value	95% CI
Romosozumab 140 mg	0
Romosozumab 210 mg	0

Mean Serum Concentration of Romosozumab Secondary · Days 4, 15, 29, 43, 57, 71 and 85

Day 4

Group	Value	95% CI
Romosozumab 140 mg	15000	± 6350
Romosozumab 210 mg	23200	± 9730

Day 15

Group	Value	95% CI
Romosozumab 140 mg	10500	± 3540
Romosozumab 210 mg	18500	± 6640

Day 29

Group	Value	95% CI
Romosozumab 140 mg	3890	± 2000
Romosozumab 210 mg	8200	± 4470

Day 43

Group	Value	95% CI
Romosozumab 140 mg	14300	± 4280
Romosozumab 210 mg	22800	± 9390

Day 57

Group	Value	95% CI
Romosozumab 140 mg	5490	± 2600
Romosozumab 210 mg	10700	± 6380

Day 71

Group	Value	95% CI
Romosozumab 140 mg	13700	± 5000
Romosozumab 210 mg	22700	± 10500

Day 85

Group	Value	95% CI
Romosozumab 140 mg	5350	± 3190
Romosozumab 210 mg	11600	± 6850

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug up to day 85. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Romosozumab 140 mg

Serious: 0/30 (0%)

Deaths: —

Romosozumab 210 mg

Serious: 0/30 (0%)

Deaths: —

Other adverse events (9 terms — click to expand)

Reaction	System	Romosozumab 140 mg	Romosozumab 210 mg
Fatigue	General disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Injection site reaction	General disorders	—	—
Oedema peripheral	General disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Contusion	Injury, poisoning and procedural complications	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT01588509 adverse events section.

Sponsor's own description

The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated with alendronate.

Publications & conference data

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

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
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
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
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

Verify or expand the search:

Other trials of Romosozumab

Trials testing the same drug.

NCT07283887 — Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis · Phase 4 · recruiting
NCT07384104 — Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in He · Phase 1 · enrolling by invitation
NCT06558188 — Combined Anabolic Therapy · Phase 4 · recruiting
NCT05972551 — Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Oste · Phase 3 · recruiting
NCT06079476 — A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture. · Phase 4 · completed

Other recruiting trials for Osteoporosis

Currently open trials in the same condition.

NCT07027306 — The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fract · recruiting
NCT07367776 — Patient Education in Osteoporosis (RCT-PATOS) · NA · recruiting
NCT06731608 — OsteoPorotic fracTure preventION System (OPTIONS) Research Study · NA · recruiting
NCT07281586 — Step-down Therapy After Long-term Osteoporosis Treatment · Phase 4 · recruiting
NCT07083557 — Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiome · recruiting

Other Amgen trials

Trials by the same sponsor.

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NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting

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 NCT01588509 (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: 26 March 2019

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/NCT01588509.

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

NCT01588509

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Romosozumab

Other recruiting trials for Osteoporosis

Other Amgen trials

Verify against primary sources