A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.

NCT00330460 | Completed Phase 3 Results

• 1 other identifier: 20050141
• Study Type: interventional
• Target: 1,189
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects receiving alendronate sodium by more than a pre-specified non-inferiority margin.

Conditions

Osteoporosis; Osteopenia

Keywords

Osteoporosis; Osteopenia; AMG 162; Fracture - hip; Postmenopausal

Outcome Measures

Primary Outcomes (1)

• Total Hip Bone Mineral Density Percent Change From Baseline at Month 12

  Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

  12 months

Secondary Outcomes (4)

• Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12

  12 months

• Trochanter Bone Mineral Density Percent Change From Baseline at Month 12

  12 months

• Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12

  12 months

• Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12

  12 months

Study Arms (2)

Alendronate

ACTIVE COMPARATOR

Subjects in this arm will receive active ALN and placebo denosumab

Drug: Alendronate

Denosumab

EXPERIMENTAL

Subjects in this arm will receive active denosumab and placbo ALN

Drug: Denosumab

Interventions

Alendronate DRUG

ALN; 70 mg; oral; once weekly

Alendronate

Denosumab DRUG

60 mg; SC; every 6 months

Denosumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Evidence of any of the following per subject report, chart review or central laboratory result:
• Hyper- or hypothyroidism; however, subjects on stable thyroid hormone replacement therapy may be allowed per the following criteria:
• If TSH level is normal, subject is eligible for the study.
• If TSH level is below normal range, subject is not eligible for the study.
• If TSH level is elevated (\> 5.5 mIU/mL to 10.0 mIU/mL), serum T4 should be measured. If serum T4 is within normal range, subject is eligible. If serum T4 is outside of normal range, subject is not eligible for the study.
• If TSH level is above 10.0 mIU/mL, subject is not eligible.
• Current hyper- or hypoparathyroidism
• Elevated transaminases
• Serum aspartate aminotransferase (AST; serum glutamate-oxaloacetic transaminase \[SGOT\]) ³ 2.0 x upper limits of normal (ULN)
• Serum alanine aminotransferase (ALT; serum glutamate-pyruvate transaminase \[SGPT\]) ³ 2.0 x ULN
• Significantly impaired renal function as determined by serum creatinine ³ 2.0 mg/dL
• Current hypo- or hypercalcemia based on the central laboratory reference ranges
• Active gastric or duodenal ulcer; history of significant gastrointestinal bleed requiring hospitalization or transfusion, or dyspepsia or gastroesophageal reflux disease that is uncontrolled by medication
• Rheumatoid Arthritis, Paget's disease, Cushing's disease, hyperprolactinemia, or cirrhosis of the liver
• Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen

Sponsors & Collaborators

• Amgen: lead

Related Publications (2)

• Brown JP, Prince RL, Deal C, Recker RR, Kiel DP, de Gregorio LH, Hadji P, Hofbauer LC, Alvaro-Gracia JM, Wang H, Austin M, Wagman RB, Newmark R, Libanati C, San Martin J, Bone HG. Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial. J Bone Miner Res. 2009 Jan;24(1):153-61. doi: 10.1359/jbmr.0809010.

  PMID: 18767928 RESULT

• Gold DT, Horne R, Coon CD, Price MA, Borenstein J, Varon SF, Satram-Hoang S, Macarios D. Development, reliability, and validity of a new Preference and Satisfaction Questionnaire. Value Health. 2011 Dec;14(8):1109-16. doi: 10.1016/j.jval.2011.06.010. Epub 2011 Oct 1.

  PMID: 22152181 DERIVED

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Hip Fractures

Interventions

Alendronate; Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 6, 2006
• First Posted: May 26, 2006
• Study Start: May 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: January 1, 2008
• Last Updated: January 24, 2011
• Results First Posted: July 19, 2010

Record last verified: 2011-01