OsteopeniaPhase 1NCT01101061

A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese 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 main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women. Read more about this study

Who is it for?: Ages 45 to 70 years, women onlyHealthy 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: 31 participants
Where: No sites listed yet
Study dates: 3 May 2010to 1 Nov 2010
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 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Japanese subjects must be first (4 grandparents, biologic parents and subject born in Japan), second (4 grandparents and biological parents born in Japan) or third (4 grandparents born in Japan) generation Japanese
Body mass index ≤ 25 kg/m², inclusive at screening
Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result > 40 mIU/mL, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in medical history (verified with an operative note, if available)

Who cannot join

Osteoporosis, as defined by bone mineral density (BMD) T-scores of the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4); or femoral neck ≤ -2.5
History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis;
Diagnosed with any condition that will affect bone metabolism

About this study

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

Conditions: Osteopenia
Being tested: Romosozumab, Placebo
Keywords: Amgen, Phase 1, Postmenopausal, Japanese
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 by subcutaneous injection
PlaceboDrug
Administered by subcutaneous injection

Study groups in NCT01101061
Study group	Role	What they receive
Romosozumab	Experimental	Japanese women in cohorts 1, 2, and 4 will receive a single dose of 1, 3, or 5 mg/kg romosozumab. Non-Japanese women in cohort 3 will receive a single dose of 3 mg/kg romosozumab. Receives: Drug: Romosozumab
Placebo	Placebo comparator	Participants will receive a single dose of placebo. Receives: Drug: Placebo

What is being measured

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

Number of Participants With Adverse Events
A serious adverse event (SAE) is defined as an adverse event that
- is fatal
- is life threatening
- requires in-patient hospitalization or prolongation of existing hospitalization
- results in persistent or significant disability/incapacity
- is a congenital anomaly/birth defect
- other significant medical hazard. A treatment-related AE is any treatment-emergent AE that per investigator review has a reasonable possibility of being caused by the investigational product.
Measured: Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments.
Number of Participants Who Developed Anti-romosozumab Binding Antibodies
Participants who were negative for anti-romosozumab binding antibodies at baseline with a positive result at any time post-baseline.
Measured: Day 29, and end of study (day 57 for participants assigned to 1 or 3 mg/kg romosozumab/placebo or day 85 for participants assigned to 5 mg/kg romosozumab/placebo)
Serum Calcium Levels
Measured: Baseline, days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85
Serum Intact Parathyroid Hormone (iPTH) Levels
Measured: Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85

Secondary outcomes (10)

Maximum Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Measured: Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85
Maximum Percent Change From Baseline in Serum C-telopeptide (CTX)
Measured: Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85
Percent Change From Baseline in Sclerostin
Measured: Baseline and days 12, 29, 43, 57, 71, and 85
Time to Maximum Observed Concentration of Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Measured: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Maximum Observed Concentration of Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Measured: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Area Under the Serum Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Measured: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Measured: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Apparent Clearance (CL/F) of Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Measured: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Half-life Associated With Beta (Plateau) Phase of Elimination (T1/2,β) for Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Measured: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Half-life Associated With Gamma (Terminal) Phase of Elimination (T1/2,ɣ) for Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Measured: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.

Timeline

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

3 May 20101 Nov 2010

First posted9 Apr 2010 (estimated)
Study start3 May 2010
Primary completion1 Nov 2010
Study completion1 Nov 2010

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.
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: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01101061
Sponsor's protocol ID: 20090378
Status last verified: Jul 2019
First submitted: 8 Apr 2010
Last updated: 31 Jul 2019
Results posted: Yes, on ClinicalTrials.gov

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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Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
Osteopenia
RecruitingObservational study
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia
Active, not recruitingPhase 2
The Effect of Oral Semaglutide on Bone Turnover in Patients With T2D: a Randomized Placebo-controlled Clinical Trial
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Sickle Cell Disease (SCD) Bone Pain Study
Sickle Cell Disease, Sickle Cell Anemia

All Osteopenia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Postmenopausal Japanese Women
ClinicalTrials.gov ID: NCT01101061
Acronym / sponsor ID: 20090378
Conditions: Osteopenia
Keywords: Amgen, Phase 1, Postmenopausal, Japanese
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 3 May 2010 (actual)
Primary completion: 1 Nov 2010 (actual)
Study completion: 1 Nov 2010 (actual)
First posted: 9 Apr 2010 (estimated)
Results: Posted 31 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
Romosozumab	Experimental	Drug: RomosozumabJapanese women in cohorts 1, 2, and 4 will receive a single dose of 1, 3, or 5 mg/kg romosozumab. Non-Japanese women in cohort 3 will receive a single dose of 3 mg/kg romosozumab.
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive a single dose of placebo.

Who may qualify

Ages: 45 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Japanese subjects must be first (4 grandparents, biologic parents and subject born in Japan), second (4 grandparents and biological parents born in Japan) or third (4 grandparents born in Japan) generation Japanese
Body mass index ≤ 25 kg/m², inclusive at screening
Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result > 40 mIU/mL, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in medical history (verified with an operative note, if available)

Key exclusion criteria (3 listed)

Osteoporosis, as defined by bone mineral density (BMD) T-scores of the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4); or femoral neck ≤ -2.5
History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis;
Diagnosed with any condition that will affect bone metabolism

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 by subcutaneous injection	Drug	Romosozumab
PlaceboAdministered by subcutaneous injection	Drug	Placebo

Primary outcome

Number of Participants With Adverse Events
Time frame: Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments.
A serious adverse event (SAE) is defined as an adverse event that * is fatal * is life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * other significant medical hazard. A treatment-related AE is any treatment-emergent AE that per investigator review has a reasonable possibility of being caused by the investigational product.
Number of Participants Who Developed Anti-romosozumab Binding Antibodies
Time frame: Day 29, and end of study (day 57 for participants assigned to 1 or 3 mg/kg romosozumab/placebo or day 85 for participants assigned to 5 mg/kg romosozumab/placebo)
Participants who were negative for anti-romosozumab binding antibodies at baseline with a positive result at any time post-baseline.
Serum Calcium Levels
Time frame: Baseline, days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85
Serum Intact Parathyroid Hormone (iPTH) Levels
Time frame: Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85

10 secondary outcomes

Maximum Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Time frame: Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85
Maximum Percent Change From Baseline in Serum C-telopeptide (CTX)
Time frame: Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85
Percent Change From Baseline in Sclerostin
Time frame: Baseline and days 12, 29, 43, 57, 71, and 85
Time to Maximum Observed Concentration of Romosozumab
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Maximum Observed Concentration of Romosozumab
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Area Under the Serum Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Romosozumab
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Romosozumab
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Apparent Clearance (CL/F) of Romosozumab
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Half-life Associated With Beta (Plateau) Phase of Elimination (T1/2,β) for Romosozumab
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Half-life Associated With Gamma (Terminal) Phase of Elimination (T1/2,ɣ) for Romosozumab
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.

Results and safety

Results posted to the registry on 31 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
Japanese Women: Placebo	6	6
Japanese Women: Romosozumab 1 mg/kg	6	6
Japanese Women: Romosozumab 3 mg/kg	7	6
Japanese Women: Romosozumab 5 mg/kg	6	6
Non-Japanese Women: Placebo	2	2
Non-Japanese Women: Romosozumab 3 mg/kg	4	4

Primary outcome: Number of Participants With Adverse Events

Time frame: Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments.. Count of participants. Unit: Participants

Measure	Japanese Women: Placebo n = 6	Japanese Women: Romosozumab 1 mg/kg n = 6	Japanese Women: Romosozumab 3 mg/kg n = 6	Japanese Women: Romosozumab 5 mg/kg n = 6	Non-Japanese Women: Placebo n = 2	Non-Japanese Women: Romosozumab 3 mg/kg n = 4
Any adverse event	6	4	3	6	2	4
Serious adverse events	0	0	0	0	0	0
Treatment-related adverse events	2	1	2	1	0	0
AEs leading to discontinuation of study drug	0	0	0	0	0	0
Deaths	0	0	0	0	0	0

Population analysed: All treated participants

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

Time frame: Day 29, and end of study (day 57 for participants assigned to 1 or 3 mg/kg romosozumab/placebo or day 85 for participants assigned to 5 mg/kg romosozumab/placebo). Count of participants. Unit: Participants

Measure	Japanese Women: Placebo n = 6	Japanese Women: Romosozumab 1 mg/kg n = 6	Japanese Women: Romosozumab 3 mg/kg n = 6	Japanese Women: Romosozumab 5 mg/kg n = 6	Non-Japanese Women: Placebo n = 2	Non-Japanese Women: Romosozumab 3 mg/kg n = 4
Value	0	0	0	0	0	0

Population analysed: All treated participants

Primary outcome: Serum Calcium Levels

Time frame: Baseline, days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85. Mean (Standard Error). Unit: mmol/L

Measure	Japanese Women: Placebo n = 6	Japanese Women: Romosozumab 1 mg/kg n = 6	Japanese Women: Romosozumab 3 mg/kg n = 6	Japanese Women: Romosozumab 5 mg/kg n = 6	Non-Japanese Women: Placebo n = 2	Non-Japanese Women: Romosozumab 3 mg/kg n = 4
Baseline	2.34 (0.04)	2.31 (0.04)	2.33 (0.03)	2.38 (0.03)	2.28 (0.08)	2.45 (0.04)
Day 2	2.33 (0.04)	2.34 (0.03)	2.31 (0.03)	2.36 (0.03)	2.34 (0.04)	2.40 (0.05)
Day 3	2.33 (0.05)	2.36 (0.04)	2.31 (0.03)	2.38 (0.03)	2.34 (0.01)	2.43 (0.03)
Day 4	2.32 (0.05)	2.31 (0.03)	2.30 (0.03)	2.32 (0.03)	2.38 (0.02)	2.36 (0.04)
Day 6	2.39 (0.05)	2.30 (0.03)	2.31 (0.04)	2.35 (0.04)	2.28 (0.02)	2.40 (0.03)
Day 8	2.39 (0.05)	2.25 (0.02)	2.31 (0.03)	2.29 (0.03)	2.35 (0.00)	2.38 (0.03)
Day 12	2.35 (0.06)	2.27 (0.05)	2.33 (0.03)	2.28 (0.02)	2.33 (0.03)	2.28 (0.04)
Day 22	2.31 (0.03)	2.31 (0.03)	2.28 (0.05)	2.25 (0.03)	2.33 (0.00)	2.36 (0.03)

Population analysed: All treated participants; only participants in the 5 mg/kg cohort were assessed at days 71 and 85.

Primary outcome: Serum Intact Parathyroid Hormone (iPTH) Levels

Time frame: Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85. Mean (Standard Error). Unit: pmol/L

Measure	Japanese Women: Placebo n = 6	Japanese Women: Romosozumab 1 mg/kg n = 6	Japanese Women: Romosozumab 3 mg/kg n = 6	Japanese Women: Romosozumab 5 mg/kg n = 6	Non-Japanese Women: Placebo n = 2	Non-Japanese Women: Romosozumab 3 mg/kg n = 4
Baseline	4.47 (0.97)	4.24 (0.70)	4.93 (0.84)	3.63 (0.62)	3.77 (1.65)	2.73 (0.37)
Day 2	4.51 (0.78)	4.92 (0.78)	5.01 (0.47)	4.23 (0.54)	3.50 (1.49)	2.57 (0.23)
Day 3	4.93 (0.71)	4.69 (0.69)	5.38 (0.44)	4.58 (0.76)	3.50 (1.06)	2.89 (0.37)
Day 4	4.47 (0.84)	5.09 (0.69)	5.09 (0.23)	5.20 (1.13)	3.93 (1.70)	3.55 (0.73)
Day 6	4.21 (0.67)	4.97 (0.93)	5.75 (0.72)	4.44 (0.77)	3.82 (1.49)	3.66 (0.66)
Day 8	4.19 (0.95)	5.91 (0.86)	5.23 (0.68)	4.79 (0.90)	4.14 (1.91)	3.98 (0.68)
Day 12	5.04 (0.95)	6.42 (0.59)	5.46 (0.41)	5.80 (0.61)	4.19 (1.86)	4.46 (0.64)
Day 22	4.69 (0.74)	5.57 (0.64)	6.15 (0.56)	7.09 (0.84)	5.46 (2.71)	4.62 (0.68)

Population analysed: All treated participants; only participants in the 5 mg/kg cohort were assessed at days 71 and 85

10 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
Japanese Women: Placebo	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Japanese Women: Romosozumab 1 mg/kg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Japanese Women: Romosozumab 3 mg/kg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Japanese Women: Romosozumab 5 mg/kg	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Non-Japanese Women: Placebo	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Non-Japanese Women: Romosozumab 3 mg/kg	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 3 inclusion and 3 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 31 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 31 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: Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments.). The study lists 4 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 NCT01101061.

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 31 Jul 2019; AzTrials last refreshed its copy on 1 Nov 2026.