OsteopeniaPhase 1NCT01059435

A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women

A Phase 1 study testing Romosozumab in people with Osteopenia, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to assess the safety and tolerability of romosozumab following single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and postmenopausal women. Read more about this study

Who is it for?: Ages 45 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Osteopenia
What is being tested?: Romosozumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: No sites listed yet
Study dates: 13 Dec 2006to 6 Jul 2007
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males or female between 45 to 59 years of age, inclusive
Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result > 40mIU/mL, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy)
Males must agree to use a condom during sexual intercourse with female partners who are of reproductive potential and to have their female partners use an additional effective means of contraception or to abstain from sexual intercourse for the duration of the study
Has no history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

Who cannot join

Diagnosed with any condition that will affect bone metabolism
Administration of the following medications within 6 months before study drug administration:
Hormone replacement therapy [Infrequent use of estrogen vaginal creams (< 3 times per week) is allowed.]
Calcitonin
Parathyroid hormone (or any derivative)
Supplemental Vitamin D > 1,000 IU/day

Show all 25Show fewer

Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed)
Anabolic steroids
Calcitriol, and available analogues
Administration of the following medications within 12 months before study drug administration:
Bisphosphonates
Fluoride for osteoporosis
Administration of herbal medications within 2 weeks or 5 half-lives (whichever is longer) before study drug administration
Greatly differing levels of physical activity or constant levels of intense physical exercise during the 6 months before study drug administration
Routine alcohol intake of > 2 drinks per day, on average, within 6 months of study drug administration
Known sensitivity to mammalian-derived drug preparations
Known to be hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV) positive, or a known diagnosis of acquired immunodeficiency syndrome (AIDS)
Any organic or psychiatric disorder which may pose a risk to subject safety and may prevent the subject from completing the study or interfere with the interpretation of the study results
Unavailable for follow-up assessment or any concerns for subject's compliance with the protocol procedures
Any other condition that might reduce the chance of obtaining data required by the protocol or that might compromise the ability to give truly informed consent
Has a history of drug or alcohol abuse with the last 12 months and/or a positive urine test result at screening or admission
Has any clinically significant abnormality during the screening physical examination, electrocardiogram (ECG), or laboratory evaluation
Has participated in another clinical study within 4 weeks of screening or within 5 times the half-life of the investigational agent in the other clinical study, if known
Weight ≥ 98 kilograms (216 pounds) and/or height ≥ 78 inches
Has donated or lost 400 milliliters or more of blood or plasma within 8 weeks of study drug administration

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Ascending Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Men and Postmenopausal Women

Conditions: Osteopenia
Being tested: Romosozumab, Placebo
Keywords: Amgen, First in Human, Postmenopausal, Phase 1
Medical subject headings: Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RomosozumabDrug
Also called AMG 785, EVENITY™
Administered subcutaneously or intravenously
PlaceboDrug
Administered subcutaneously or intravenously

Study groups in NCT01059435
Study group	Role	What they receive
Placebo	Placebo comparator	Participants were randomized to receive a single dose of matching placebo administered by subcutaneous or intravenous injection. Receives: Drug: Placebo
Romosozumab	Experimental	Participants were randomized to receive a single dose of romosozumab administered by subcutaneous or intravenous injection. The starting dose was 0.1 mg/kg, with sequential escalation up to 10 mg/kg. Receives: Drug: Romosozumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards.
Relatedness to investigational product was assessed by the investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?'
Measured: Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Number of Participants Who Developed Anti-romosozumab Antibodies
Binding anti-romosozumab antibody titers were assessed using a validated electrochemiluninescence (ECL) immunoassay. The limit of detection for this assay was 3.91 ng/mL of anti-romosozumab antibody in neat serum. Samples found to be positive for binding antibodies were further tested using a validated bioassay to determine if the antibodies were able to neutralize the activity of romosozumab. The limit of detection for this assay was ≥ 0.75 μg/mL.
Measured: Day 29 (all participants), day 57 (1, 3, 5, and 10 mg/kg treatment groups only) and at day 85 (5 and 10 mg/kg teatment groups only).

Secondary outcomes (30)

Maximum Observed Concentration (Cmax) of Romosozumab
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Time to Maximum Observed Concentration (Tmax) of Romosozumab
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Initial Concentration Following IV Administration (C0) of Romosozumab
Measured: Day 1 at the end of infusion
Area Under the Serum Concentration-time Curve From Time Zero to Infinity for Romosozumab
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Apparent Clearance (CL/F) / Clearance (CL) for Romosozumab
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Half-life Associated With the Beta (Plateau) Phase of Elimination for Romosozumab
The plateau (beta, β) phase half-life (t½,β) was calculated from the natural log of 2 divided by the beta phase rate constant (λβ). λβ for a subject was estimated by linear regression of at least 3 contiguous time points that followed the Cmax and constituted a distinct phase that preceded the terminal phase.
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Half-life Associated With the Gamma (Terminal) Phase of Elimination for Romosozumab
The terminal (gamma, γ) phase half-life (t½,γ) was calculated from the natural log of 2 divided by the terminal rate constant (λz).
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Maximum Effect for Serum Type 1 Aminoterminal Propeptide (P1NP)
Defined as the maximum value postdose.
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Time to Maximum Effect of P1NP
Defined as the time to maximum value postdose.
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for P1NP
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for P1NP
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab,
Maximum Effect for Serum C-telopeptide (sCTX)
Defined as the minimum value postdose.
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Time to Maximum Effect of sCTX
Defined as the time to minimum value postdose.
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for sCTX
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for sCTX
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Maximum Effect for Osteocalcin
Defined as the maximum value postdose.
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Time to Maximum Effect of Osteocalcin
Defined as the time to maximum value postdose.
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for Osteocalcin
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for Osteocalcin
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Maximum Effect for Bone-specific Alkaline Phosphatase (BSAP)
Defined as the maximum value postdose.
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Time to Maximum Effect of BSAP
Defined as the time to maximum value postdose.
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for BSAP
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for BSAP
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Maximum Effect for Intact Parathyroid Hormone (iPTH)
Defined as the maximum value postdose.
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Time to Maximum Effect of iPTH
Defined as the time to maximum value postdose.
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for iPTH
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to the Last Sampling Timepoint (AUC0-t) for iPTH
Measured: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Percent Change From Baseline in Sclerostin
Measured: Baseline and days 15, 29, 43, 57, 71, and 85
Serum Calcium Over Time
Measured: Dday 1 predose and at 4, 6, 8, 10, and 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
Ionized Calcium Over Time
Measured: Day 1 predose and at 4, 6, 8, 10, 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 20066 Jul 2007

First posted1 Feb 2010 (estimated)
Study start13 Dec 2006
Primary completion6 Jul 2007
Study completion6 Jul 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OsteopeniaStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01059435
Sponsor's protocol ID: 20060220
Status last verified: Jul 2019
First submitted: 28 Jan 2010
Last updated: 5 Jul 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Padhi D, Jang G, Stouch B, Fang L, Posvar E. Single-dose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody. J Bone Miner Res. 2011 Jan;26(1):19-26. doi: 10.1002/jbmr.173.
PubMed 20593411

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Osteopenia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Ascending Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Men and Postmenopausal Women
ClinicalTrials.gov ID: NCT01059435
Acronym / sponsor ID: 20060220
Conditions: Osteopenia
Keywords: Amgen, First in Human, Postmenopausal, Phase 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 13 Dec 2006 (actual)
Primary completion: 6 Jul 2007 (actual)
Study completion: 6 Jul 2007 (actual)
First posted: 1 Feb 2010 (estimated)
Results: Posted 5 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants were randomized to receive a single dose of matching placebo administered by subcutaneous or intravenous injection.
Romosozumab	Experimental	Drug: RomosozumabParticipants were randomized to receive a single dose of romosozumab administered by subcutaneous or intravenous injection. The starting dose was 0.1 mg/kg, with sequential escalation up to 10 mg/kg.

Who may qualify

Ages: 45 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy males or female between 45 to 59 years of age, inclusive
Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result > 40mIU/mL, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy)
Males must agree to use a condom during sexual intercourse with female partners who are of reproductive potential and to have their female partners use an additional effective means of contraception or to abstain from sexual intercourse for the duration of the study
Has no history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

Key exclusion criteria (25 listed)

Diagnosed with any condition that will affect bone metabolism
Administration of the following medications within 6 months before study drug administration:
Hormone replacement therapy [Infrequent use of estrogen vaginal creams (< 3 times per week) is allowed.]
Calcitonin
Parathyroid hormone (or any derivative)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RomosozumabAlso: AMG 785, EVENITY™Administered subcutaneously or intravenously	Drug	Romosozumab
PlaceboAdministered subcutaneously or intravenously	Drug	Placebo

Primary outcome

Number of Participants With Adverse Events
Time frame: Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.
Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards. Relatedness to investigational product was assessed by the investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?'
Number of Participants Who Developed Anti-romosozumab Antibodies
Time frame: Day 29 (all participants), day 57 (1, 3, 5, and 10 mg/kg treatment groups only) and at day 85 (5 and 10 mg/kg teatment groups only).
Binding anti-romosozumab antibody titers were assessed using a validated electrochemiluninescence (ECL) immunoassay. The limit of detection for this assay was 3.91 ng/mL of anti-romosozumab antibody in neat serum. Samples found to be positive for binding antibodies were further tested using a validated bioassay to determine if the antibodies were able to neutralize the activity of romosozumab. The limit of detection for this assay was ≥ 0.75 μg/mL.

30 secondary outcomes

Maximum Observed Concentration (Cmax) of Romosozumab
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Time to Maximum Observed Concentration (Tmax) of Romosozumab
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Initial Concentration Following IV Administration (C0) of Romosozumab
Time frame: Day 1 at the end of infusion
Area Under the Serum Concentration-time Curve From Time Zero to Infinity for Romosozumab
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Apparent Clearance (CL/F) / Clearance (CL) for Romosozumab
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Half-life Associated With the Beta (Plateau) Phase of Elimination for Romosozumab
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Half-life Associated With the Gamma (Terminal) Phase of Elimination for Romosozumab
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Maximum Effect for Serum Type 1 Aminoterminal Propeptide (P1NP)
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Time to Maximum Effect of P1NP
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for P1NP
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for P1NP
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab,
Maximum Effect for Serum C-telopeptide (sCTX)
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Time to Maximum Effect of sCTX
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for sCTX
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for sCTX
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Maximum Effect for Osteocalcin
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Time to Maximum Effect of Osteocalcin
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for Osteocalcin
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for Osteocalcin
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Maximum Effect for Bone-specific Alkaline Phosphatase (BSAP)
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Time to Maximum Effect of BSAP
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for BSAP
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for BSAP
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Maximum Effect for Intact Parathyroid Hormone (iPTH)
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Time to Maximum Effect of iPTH
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to Day 29 (AUC0-29) for iPTH
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Area Under the Curve From Day 0 to the Last Sampling Timepoint (AUC0-t) for iPTH
Time frame: Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.
Percent Change From Baseline in Sclerostin
Time frame: Baseline and days 15, 29, 43, 57, 71, and 85
Serum Calcium Over Time
Time frame: Dday 1 predose and at 4, 6, 8, 10, and 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
Ionized Calcium Over Time
Time frame: Day 1 predose and at 4, 6, 8, 10, 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85

Results and safety

Results posted to the registry on 5 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo SC	14	14
Romosozumab 0.1 mg/kg SC	6	6
Romosozumab 0.3 mg/kg SC	8	6
Romosozumab 1.0 mg/kg SC	9	9
Romosozumab 3.0 mg/kg SC	6	6
Romosozumab 5.0 mg/kg SC	9	9
Romosozumab 10.0 mg/kg SC	6	6
Placebo IV	4	4
Romosozumab 1.0 mg/kg IV	6	6
Romosozumab 5.0 mg/kg IV	6	6

Primary outcome: Number of Participants With Adverse Events

Time frame: Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.. Count of participants. Unit: Participants

Measure	Placebo SC n = 14	Romosozumab 0.1 mg/kg SC n = 6	Romosozumab 0.3 mg/kg SC n = 6	Romosozumab 1.0 mg/kg SC n = 9	Romosozumab 3.0 mg/kg SC n = 6	Romosozumab 5.0 mg/kg SC n = 9	Romosozumab 10.0 mg/kg SC n = 6	Placebo IV n = 4	Romosozumab 1.0 mg/kg IV n = 6	Romosozumab 5.0 mg/kg IV n = 6
Any adverse event	9	4	4	1	5	6	5	2	1	2
Serious adverse events	0	0	0	0	0	0	1	0	0	0
Treatment-related adverse events	5	4	2	0	3	4	5	0	1	1
Serious treatment-related adverse events	0	0	0	0	0	0	1	0	0	0
Discontinuations due to adverse events	0	0	0	0	0	0	0	0	0	0
Deaths	0	0	0	0	0	0	0	0	0	0

Population analysed: All treated participants

Primary outcome: Number of Participants Who Developed Anti-romosozumab Antibodies

Time frame: Day 29 (all participants), day 57 (1, 3, 5, and 10 mg/kg treatment groups only) and at day 85 (5 and 10 mg/kg teatment groups only).. Number. Unit: participants

Measure	Placebo SC n = 14	Romosozumab 0.1 mg/kg SC n = 6	Romosozumab 0.3 mg/kg SC n = 6	Romosozumab 1.0 mg/kg SC n = 9	Romosozumab 3.0 mg/kg SC n = 6	Romosozumab 5.0 mg/kg SC n = 9	Romosozumab 10.0 mg/kg SC n = 6	Placebo IV n = 4	Romosozumab 1.0 mg/kg IV n = 6	Romosozumab 5.0 mg/kg IV n = 6
Binding antibody positive	0	0	0	0	0	2	2	0	0	2
Neutralizing antibody positive	0	0	0	0	0	0	1	0	0	0

Population analysed: All treated participants

30 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
Placebo SC	0 of 14 (0%)	9 of 14 (64.3%)	Not reported
Placebo IV	0 of 4 (0%)	2 of 4 (50%)	Not reported
Romosozumab 0.1 mg/kg SC	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Romosozumab 0.3 mg/kg SC	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Romosozumab 1.0 mg/kg SC	0 of 9 (0%)	1 of 9 (11.1%)	Not reported
Romosozumab 10.0 mg/kg SC	1 of 6 (16.7%)	5 of 6 (83.3%)	Not reported
Romosozumab 3.0 mg/kg SC	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Romosozumab 5.0 mg/kg SC	0 of 9 (0%)	6 of 9 (66.7%)	Not reported
Romosozumab 1.0 mg/kg IV	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Romosozumab 5.0 mg/kg IV	0 of 6 (0%)	2 of 6 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20593411Padhi D, Jang G, Stouch B, Fang L, Posvar E. Single-dose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody. J Bone Miner Res. 2011 Jan;26(1):19-26. doi: 10.1002/jbmr.173.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Romosozumab in people with Osteopenia, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01059435, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.