Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density

September 6, 2013 updated by: Amgen

A Randomized, Double-Blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 162 in the Treatment of Postmenopausal Women With Low Bone Mineral Density

To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12 months will significantly increase lumbar spine bone mineral density and will be well tolerated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
412

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • women not more than 80 years of age on date of randomization
  • ≥ 1 year postmenopausal on date of randomization
  • ambulatory
  • if ≤ 60 years of age, or had or would require a bilateral oophorectomy, serum follicle stimulating hormone (FSH) > 50 mU/mL or serum estradiol < 20 pg/mL
  • low BMD (BMD T-score ≤ -1.8 at any 1 of the following sites: lumbar spine, femoral neck, or total hip; BMD T-scores must not have been < -4.0 at the lumbar spine or - 3.5 at the femoral neck or total hip)
  • before any study-specific procedure, including the screening dual X-ray absorptiometry (DXA) scan, gave informed consent for participation in the study.

Exclusion Criteria

  • fluoride treatment for osteoporosis within the 2 years before the enrollment date
  • bisphosphonate use within the 12 months before the enrollment date

  • administration of the following medications within the 6 months before the enrollment date

    • tibolone
    • Parathyroid hormone (PTH) (or any derivative)
    • systemic glucocorticosteroids (> 5 mg oral prednisone equivalent per day for > 10 days)
    • inhaled corticosteroids (> 2000 μg per day for > 10 days)
    • anabolic steroids or testosterone

  • administration of the following medications within the 3 months before the enrollment date

    • systemic hormone replacement therapy
    • selective estrogen receptor modulators
    • calcitonin
    • calcitriol
  • current hyper- or hypothyroidism (allowed if stable on thyroid replacement therapy and thyroid-stimulating hormone was within the normal range)
  • current hyper- or hypoparathyroidism
  • albumin-adjusted serum calcium < 8.5 mg/dL (< 2.125 mol/L)
  • osteomalacia
  • rheumatoid arthritis
  • Paget's disease
  • malignancy within the 5 years before enrollment (except cervical carcinoma in situ or basal cell carcinoma, which were acceptable)
  • renal disease; ie, creatinine clearance ≤ 35 mL/min
  • any bone disease, other than osteoporosis, which could interfere with the interpretation of the findings (eg, osteogenesis imperfecta or osteopetrosis)
  • malabsorption syndrome
  • weight, height, or girth that could preclude accurate DXA measurements
  • < 2 lumbar vertebrae (L1 through L4) evaluable by DXA
  • recent long bone fracture (within 6 months)
  • osteoporotic-related fracture (ie, crush or wedge vertebral fracture or hip fracture) known or suspected to have occurred within 2 years of randomization
  • > 1 single, grade 1 vertebral fracture
  • currently enrolled in or had participated within the previous 30 days in other investigational device or drug trial(s) (For some trials, this may have been allowed after discussion and written approval from Amgen.)
  • known sensitivity to mammalian-derived drug preparations (eg, Herceptin®)
  • any organic or psychiatric disorder, serum chemistry, or hematology that, in the opinion of the investigator, could have prevented the subject from completing the study or have interfered with the interpretation of the study results
  • self-reported alcohol or drug abuse within the previous 12 months
  • any disorder that compromised the ability to give truly informed consent for participation in the study
  • previous administration of denosumab
  • known sensitivity or contraindication to alendronate
  • known sensitivity or contraindication to tetracycline derivatives (subjects in the biopsy substudy only).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
Drug: Placebo
Placebo subcutaneous injection
Experimental: Denosumab 6 mg every 3 months
Participants received denosumab 6 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
Drug: Denosumab
Denosumab for subcutaneous injection
Other Names:
  • Prolia
  • AMG 162
Experimental: Denosumab 14 mg every 3 months
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
Drug: Denosumab
Denosumab for subcutaneous injection
Other Names:
  • Prolia
  • AMG 162
Experimental: Denosumab 30 mg every 3 months
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
Drug: Denosumab
Denosumab for subcutaneous injection
Other Names:
  • Prolia
  • AMG 162
Experimental: Denosumab 14 mg every 6 months
Participants received denosumab 14 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
Drug: Denosumab
Denosumab for subcutaneous injection
Other Names:
  • Prolia
  • AMG 162
Experimental: Denosumab 60 mg every 6 months
Participants received denosumab 60 mg SC every 6 months until Month 42.
Drug: Denosumab
Denosumab for subcutaneous injection
Other Names:
  • Prolia
  • AMG 162
Experimental: Denosumab 100 mg every 6 months
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
Drug: Denosumab
Denosumab for subcutaneous injection
Other Names:
  • Prolia
  • AMG 162
Experimental: Denosumab 210 mg every 6 months
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
Drug: Denosumab
Denosumab for subcutaneous injection
Other Names:
  • Prolia
  • AMG 162
Active Comparator: Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Drug: Alendronate
Alendronate 70 mg tablets
Other Names:
  • Fosamax

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms
Time Frame: Baseline and Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum CTX Percent Change From Baseline at Month 12
Time Frame: Baseline and Month 12
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and Month 12
Urine NTX/Creatinine Percent Change From Baseline at Month 12
Time Frame: Baseline and Month 12
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and Month 12
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm
Time Frame: Baseline and Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and Month 12
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
Time Frame: Baseline and 24 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36
Time Frame: Baseline and 36 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42
Time Frame: Baseline and 42 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48
Time Frame: Baseline and 48 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Baseline and 48 months
Serum CTX Percent Change From Baseline at Month 24
Time Frame: Baseline and 24 months
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Serum CTX Percent Change From Baseline at Month 36
Time Frame: Baseline and 36 months
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Serum CTX Percent Change From Baseline at Month 42
Time Frame: Baseline and 42 months
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Serum CTX Percent Change From Baseline at Month 48
Time Frame: Baseline and 48 months
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Baseline and 48 months
Urine NTX/Creatinine Percent Change From Baseline at Month 24
Time Frame: Baseline and 24 months
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Urine NTX/Creatinine Percent Change From Baseline at Month 36
Time Frame: Baseline and 36 months
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Urine NTX/Creatinine Percent Change From Baseline at Month 42
Time Frame: Baseline and 42 months
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Urine NTX/Creatinine Percent Change From Baseline at Month 48
Time Frame: Baseline and 48 months
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Baseline and 48 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
Time Frame: Baseline and 12 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and 12 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
Time Frame: Baseline and 24 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 36
Time Frame: Baseline and 36 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 42
Time Frame: Baseline and 42 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 48
Time Frame: Baseline and 48 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Baseline and 48 months
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12
Time Frame: Baseline and 12 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and 12 months
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24
Time Frame: Baseline and 24 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36
Time Frame: Baseline and 36 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42
Time Frame: Baseline and 42 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48
Time Frame: Baseline and 48 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Baseline and 48 months
Total Body Bone Mineral Density Percent Change From Baseline at Month 12
Time Frame: Baseline and 12 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and 12 months
Total Body Bone Mineral Density Percent Change From Baseline at Month 24
Time Frame: Baseline and 24 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Total Body Bone Mineral Density Percent Change From Baseline at Month 36
Time Frame: Baseline and 36 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Total Body Bone Mineral Density Percent Change From Baseline at Month 42
Time Frame: Baseline and 42 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Total Body Bone Mineral Density Percent Change From Baseline at Month 48
Time Frame: Baseline and 48 months
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Baseline and 48 months
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12
Time Frame: Baseline and 12 months
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and 12 months
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24
Time Frame: Baseline and 24 months
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36
Time Frame: Baseline and 36 months
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42
Time Frame: Baseline and 42 months
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48
Time Frame: Baseline and 48 months
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Baseline and 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2002

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20010223

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