Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low Bone Mineral Density
Intervention: Placebo (Drug); Denosumab (Drug); Alendronate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms
Secondary outcome: Serum CTX Percent Change From Baseline at Month 12Urine NTX/Creatinine Percent Change From Baseline at Month 12 Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42 Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48 Serum CTX Percent Change From Baseline at Month 24 Serum CTX Percent Change From Baseline at Month 36 Serum CTX Percent Change From Baseline at Month 42 Serum CTX Percent Change From Baseline at Month 48 Urine NTX/Creatinine Percent Change From Baseline at Month 24 Urine NTX/Creatinine Percent Change From Baseline at Month 36 Urine NTX/Creatinine Percent Change From Baseline at Month 42 Urine NTX/Creatinine Percent Change From Baseline at Month 48 Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Total Hip Bone Mineral Density Percent Change From Baseline at Month 42 Total Hip Bone Mineral Density Percent Change From Baseline at Month 48 Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12 Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24 Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36 Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42 Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48 Total Body Bone Mineral Density Percent Change From Baseline at Month 12 Total Body Bone Mineral Density Percent Change From Baseline at Month 24 Total Body Bone Mineral Density Percent Change From Baseline at Month 36 Total Body Bone Mineral Density Percent Change From Baseline at Month 42 Total Body Bone Mineral Density Percent Change From Baseline at Month 48 Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12 Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24 Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36 Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42 Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48
Eligibility
Minimum age: N/A.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
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).
Locations and Contacts
Additional Information
AmgenTrials clinical trials website
Starting date: May 2002
Last updated: September 6, 2013
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