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OpenTrials
Completed

NCT Number: NCT00043186

Determine the Efficacy, Safety and Tolerability of Denosumab (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.

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Key information

Conditions

Low Bone Mineral Density Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

Up to 80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Placebo

Drug

Placebo subcutaneous injection

Denosumab

Drug

Denosumab for subcutaneous injection

Other names: AMG 162, Prolia

Alendronate

Drug

Alendronate 70 mg tablets

Other names: Fosamax

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Aug 7, 2002
Registry last updated
Sep 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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