OsteopeniaPhase 1NCT00950950
A Study to Evaluate the Effect of Romosozumab (AMG 785) on Bone Quality of the Forearm in Postmenopausal Women With Low Bone Mass
A Phase 1 study testing Romosozumab in people with Osteopenia, run by Amgen.
Trial summary
The purpose of this study is to evaluate the effect of romosozumab on parameters of bone quality of the forearm using peripheral quantitative computed tomography (pQCT) following multiple subcutaneous dose administrations of romosozumab in postmenopausal women with low bone mass. Read more about this study
- Who is it for?
- Ages 55 to 80 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
- 24 participants
- Where
- No sites listed yet
- Study dates
- 18 Aug 2009to 19 Aug 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 55 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy females between 55 to 80 years of age
- Postmenopausal females (based on medical history) defined as 12 continuous months of spontaneous amenorrhea
- Women 60 years of age and older will be considered postmenopausal
- Women 55-59 must have a serum follicle-stimulating hormone result > 40 mIU/mL and serum estradiol ≤ 20 pg/mL
- Low bone mineral density (BMD), defined as a BMD T-score between -1.0 and -2.5 at the lumbar spine (L1-L4) and/or femoral neck
- Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in)
- 25-hydroxyvitamin D ≥ 20 ng/mL at screening
- Willing and able to take ≥ 500 mg calcium and ≥ 400 IU (but ≤ 1,000 IU) vitamin D daily
Who cannot join
- Osteoporosis, defined as a BMD T-score ≤ -2.5 at the lumbar spine or femoral neck
- History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis
- Diagnosed with any condition that will affect bone metabolism
- Subjects with fewer than 2 evaluable vertebrae; metal in forearms bilaterally that would not allow for at least one evaluable forearm
- Administration of the following medications within 6 months before study drug administration. This includes all routes of administration, for example intranasal and topical skin patches, unless otherwise noted:
- Hormone replacement therapy [(eg, estrogen, estrogen-like compounds such as raloxifene). Infrequent use of estrogen vaginal creams (< 3 times per week) is allowed.]
Show all 27Show fewer
- Calcitonin
- Parathyroid hormone (or any derivative)
- Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed)
- Anabolic steroids
- Calcitriol, and available analogues
- Administration of daily, weekly, or monthly bisphosphonates (BP) unless meeting the following criteria:
- < 2 weeks of BP use requires a 2-month washout period
- 2 weeks to 3 months of BP use requires a 9-month washout period
- 3 to 6 months of BP use requires a 1-year washout period
- > 6 months of BP use requires a 3-year washout period;
- Greatly differing levels of physical activity or constant levels of intense physical exercise during the 6 months before 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, in the opinion of the investigator, poses 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
- History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Clinically significant abnormality during the screening physical examination, electrocardiogram (ECG) or laboratory evaluation
- Participation 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
- Has donated or lost 400 mL or more of blood or plasma within 8 weeks of study drug administration
- Previous AMG 785 exposure
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate the Effect of AMG 785 on Parameters of Bone Quality of the Forearm Using pQCT in Postmenopausal Women With Low Bone Mineral Density
The purpose of this study is to evaluate the effect of romosozumab on parameters of bone quality of the forearm using peripheral quantitative computed tomography (pQCT) following multiple subcutaneous dose administrations of romosozumab in postmenopausal women with low bone mass.
- Conditions
- Osteopenia
- Being tested
- Romosozumab, Placebo
- Keywords
- Amgen, Postmenopausal, Bone Density
- 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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants were randomized to receive matching placebo administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months. Receives: Drug: Placebo |
| Romosozumab | Experimental | Participants were randomized to receive 3 mg/kg romosozumab administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months. Receives: Drug: Romosozumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius
The polar moment of inertia is a geometric measurement used to predict bone quality, specifically the ability to resist torsion (twisting), and is highly correlated with fracture load at the distal radius. The polar cross-sectional moment of inertia was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Secondary outcomes (31)
Percent Change From Baseline in Total Bone Area at the Distal Radius
Total bone area was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius
Total bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius
Total bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Cortical Bone Area at the Distal Radius
Cortical bone area was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius
Cortical bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius
Cortical bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Endocortical Circumference at the Distal Radius
Endocortical circumference was derived from pQCT measurements based on applying a circular ring model to the cortical shell. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Periosteal Circumference at the Distal Radius
Periosteal circumference was derived from pQCT measurements based on applying a circular ring model to the cortical shell. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Cortical Thickness at the Distal Radius
Cortical thickness was derived from pQCT measurements based on applying a circular ring model to the cortical shell. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Polar Section Modulus at the Distal Radius
Polar section modulus is a measurement of bone strength and was derived from pQCT measurements. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius
The polar strength strain index is a measurement of bone strength and was derived from pQCT measurements. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius
Axial moment of inertia is an indicator of the ability of bone to resist bending, and was derived from pQCT measurements based on a circular ring model. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Total Bone Area at the Ultradistal Radius
Total bone area was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius
Total bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius
Total bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius
Trabecular bone area was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius
Trabecular bone mineral content was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius
Trabecular bone mineral density was assessed using peripheral quantitative computed tomography (pQCT). The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius
The polar strength strain index is a measurement of bone strength and was derived from pQCT measurements. The ultradistal slice was acquired at 4% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Bone Mineral Density at the One-third Radius
Bone mineral density was assessed using dual energy x-ray absorptiometry (DXA). Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Bone Mineral Density at the Total Wrist
Bone mineral density was assessed using dual energy x-ray absorptiometry (DXA). Scans were analyzed by a central reader.
Measured: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Bone Mineral Density at the Total Lumbar Spine
Bone mineral density was assessed using dual energy x-ray absorptiometry (DXA). Scans were analyzed by a central reader.
Measured: Baseline and days 85 and 169
Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Measured: Baseline and days 4, 15, 29, 57, 62, 71, 85, 99, 127, and 169
Percent Change From Baseline in Serum C-Telopeptide (sCTX)
Measured: Baseline and days 4, 15, 29, 57, 62, 71, 85, 99, 127, and 169
Time to Maximum Serum Concentration (Tmax) of Romosozumab
Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL.
Measured: First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Maximum Serum Concentration (Cmax) of Romosozumab
Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL.
Measured: First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Area Under the Serum Concentration-time Curve From Time 0 to Tau (AUC0-28)
Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL.
The area under the serum drug concentration-time curve from time zero to tau (tau = 28 days) (AUC0-28) was calculated by the linear trapezoidal method.
Measured: First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf)
Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL.
Measured: Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Apparent Clearance (CL/F) of Romosozumab
Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL.
Measured: Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Terminal Half-life (t1/2,z) of Romosozumab
Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay. The lower limit of quantification (LLOQ) was 50 ng/mL.
Measured: Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Accumulation Ratio
Accumulation ratio was calculated as the ratio of AUC0-28 after the last dose to AUC0-28 after the first dose.
Measured: First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study start18 Aug 2009
- Primary completion19 Aug 2010
- Study completion19 Aug 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950950
- Sponsor's protocol ID
- 20090153
- Status last verified
- Mar 2019
- First submitted
- 30 Jul 2009
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
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, Multiple Dose Study to Evaluate the Effect of AMG 785 on Parameters of Bone Quality of the Forearm Using pQCT in Postmenopausal Women With Low Bone Mineral Density
- ClinicalTrials.gov ID
- NCT00950950
- Acronym / sponsor ID
- 20090153
- Conditions
- Osteopenia
- Keywords
- Amgen, Postmenopausal, Bone Density
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2009 (actual)
- Primary completion
- 19 Aug 2010 (actual)
- Study completion
- 19 Aug 2010 (actual)
- First posted
- 3 Aug 2009 (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.
The purpose of this study is to evaluate the effect of romosozumab on parameters of bone quality of the forearm using peripheral quantitative computed tomography (pQCT) following multiple subcutaneous dose administrations of romosozumab in postmenopausal women with low bone mass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants were randomized to receive matching placebo administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months. |
| Romosozumab | Experimental | Drug: RomosozumabParticipants were randomized to receive 3 mg/kg romosozumab administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy females between 55 to 80 years of age
- Postmenopausal females (based on medical history) defined as 12 continuous months of spontaneous amenorrhea
- Low bone mineral density (BMD), defined as a BMD T-score between -1.0 and -2.5 at the lumbar spine (L1-L4) and/or femoral neck
- Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in)
- 25-hydroxyvitamin D ≥ 20 ng/mL at screening
Key exclusion criteria (27 listed)
- Osteoporosis, defined as a BMD T-score ≤ -2.5 at the lumbar spine or femoral neck
- History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis
- Diagnosed with any condition that will affect bone metabolism
- Subjects with fewer than 2 evaluable vertebrae; metal in forearms bilaterally that would not allow for at least one evaluable forearm
- Administration of the following medications within 6 months before study drug administration. This includes all routes of administration, for example intranasal and topical skin patches, unless otherwise noted:
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
Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
The polar moment of inertia is a geometric measurement used to predict bone quality, specifically the ability to resist torsion (twisting), and is highly correlated with fracture load at the distal radius. The polar cross-sectional moment of inertia was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.
31 secondary outcomes
Percent Change From Baseline in Total Bone Area at the Distal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Cortical Bone Area at the Distal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Endocortical Circumference at the Distal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Periosteal Circumference at the Distal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Cortical Thickness at the Distal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Polar Section Modulus at the Distal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Total Bone Area at the Ultradistal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Bone Mineral Density at the One-third Radius
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Bone Mineral Density at the Total Wrist
Time frame: Baseline and days 29, 57, 85, 127, and 169
Percent Change From Baseline in Bone Mineral Density at the Total Lumbar Spine
Time frame: Baseline and days 85 and 169
Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Time frame: Baseline and days 4, 15, 29, 57, 62, 71, 85, 99, 127, and 169
Percent Change From Baseline in Serum C-Telopeptide (sCTX)
Time frame: Baseline and days 4, 15, 29, 57, 62, 71, 85, 99, 127, and 169
Time to Maximum Serum Concentration (Tmax) of Romosozumab
Time frame: First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Maximum Serum Concentration (Cmax) of Romosozumab
Time frame: First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Area Under the Serum Concentration-time Curve From Time 0 to Tau (AUC0-28)
Time frame: First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf)
Time frame: Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Apparent Clearance (CL/F) of Romosozumab
Time frame: Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Terminal Half-life (t1/2,z) of Romosozumab
Time frame: Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Accumulation Ratio
Time frame: First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169
Results and safety
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.
- 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 8 inclusion and 27 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?
Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius (time frame: Baseline and days 29, 57, 85, 127, and 169). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.