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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Alendronate; Denosumab

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).