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

Phase 2

Completed

• Conditions: Low Bone Mineral Density
• Interventions: Drug: Placebo; Drug: Denosumab; Drug: Alendronate

• Registration Number: NCT00043186
• Lead Sponsor: Amgen

Brief 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 w...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-08-06
• Study First Submitted QC: 2002-08-06
• Study First Posted: 2002-08-07
• Primary Completion: 2007-04
• Study Completion: 2007-06
• Disposition First Submitted: 2009-11-23
• Disposition First Submitted QC: 2009-11-23
• Disposition First Posted: 2009-11-25
• Results First Submitted: 2009-12-22
• Results First Submitted QC: 2010-06-25
• Results First Posted: 2010-07-28
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-06
• Last Update Posted: 2013-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 412

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Denosumab 6 mg every 3 months	Denosumab	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.
Denosumab 60 mg every 6 months	Denosumab	Participants received denosumab 60 mg SC every 6 months until Month 42.
Denosumab 14 mg every 3 months	Denosumab	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.
Denosumab 30 mg every 3 months	Denosumab	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.
Denosumab 14 mg every 6 months	Denosumab	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.
Denosumab 100 mg every 6 months	Denosumab	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.
Denosumab 210 mg every 6 months	Denosumab	Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
Alendronate 70 mg	Alendronate	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.

Primary Outcome Measures

Name	Time	Method
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms	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 Outcome Measures

Name	Time	Method
Serum CTX Percent Change From Baseline at Month 12	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.
Urine NTX/Creatinine Percent Change From Baseline at Month 12	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.
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42	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.
Serum CTX Percent Change From Baseline at Month 36	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.
Serum CTX Percent Change From Baseline at Month 42	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.
Serum CTX Percent Change From Baseline at Month 48	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.
Urine NTX/Creatinine Percent Change From Baseline at Month 24	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.
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm	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.
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24	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.
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36	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.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12	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.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24	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.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 36	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.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 42	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.
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48	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.
Serum CTX Percent Change From Baseline at Month 24	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.
Urine NTX/Creatinine Percent Change From Baseline at Month 36	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.
Urine NTX/Creatinine Percent Change From Baseline at Month 42	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.
Urine NTX/Creatinine Percent Change From Baseline at Month 48	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.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 48	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.
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12	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.
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24	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.
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36	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.
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42	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.
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48	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.
Total Body Bone Mineral Density Percent Change From Baseline at Month 12	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.
Total Body Bone Mineral Density Percent Change From Baseline at Month 24	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.
Total Body Bone Mineral Density Percent Change From Baseline at Month 36	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.
Total Body Bone Mineral Density Percent Change From Baseline at Month 42	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.
Total Body Bone Mineral Density Percent Change From Baseline at Month 48	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.
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12	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.
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24	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.
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36	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.
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42	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.
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48	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.