Study of Transitioning From Alendronate to Denosumab

• ClinicalTrials.gov Identifier: NCT00377819
• Recruitment Status: Completed
• First Posted: September 18, 2006
• Results First Posted: August 3, 2010
• Last Update Posted: July 11, 2011
• Sponsor: Amgen
• Information provided by: Amgen

Study Description

Brief Summary:

The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.

Condition or disease	Intervention/treatment	Phase
Postmenopausal Osteoporosis	Drug: alendronate; Drug: Denosumab (AMG 162)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 504 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women With Low Bone Mineral Density
• Study Start Date: September 2006
• Actual Primary Completion Date: March 2008
• Actual Study Completion Date: July 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: denosumab	Drug: Denosumab (AMG 162); 60 mg SC q 6 mos
Active Comparator: alendronate	Drug: alendronate; 70 mg oral QW

Outcome Measures

Primary Outcome Measures :

1. Percent Change From Baseline in Total Hip Bone Mineral Density [ Time Frame: Baseline, 12 months ]
   Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.

Secondary Outcome Measures :

1. Percent Change From Baseline in Lumbar Spine Bone Mineral Density [ Time Frame: Baseline, 12 months ]
   Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.
2. Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I) [ Time Frame: Baseline, 3 months ]
   Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100.

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Postmenopausal females 55 yrs or older
• Received alendronate therapy for osteoporosis for at least 6 months prior to entry into study
• Lumbar spine or total hip Bone Mineral Density (BMD) corresponding to T-score ≤ -2 and ≥ -4

Exclusion Criteria:

• Vitamin D deficiency
• Administration of intravenous bisphosphonate, or
• fluoride (except for dental treatment) or
• strontium ranelate
• Administration of Parathyroid Hormone (PTH) or Parathyroid Hormone (PTH) derivatives (eg; teriparatide) within the last year
• Administration of any bisphosphonate other than alendronate (ALN) within 1 year of screening

Contacts and Locations

Sponsors and Collaborators

Amgen

Investigators

• Study Director: MD; Amgen

More Information

Additional Information:

Notice regarding posted summaries of trial results 

AmgenTrials clinical trials website 

Publications of Results:

Kendler DL, Roux C, Benhamou CL, Brown JP, Lillestol M, Siddhanti S, Man HS, San Martin J, Bone HG. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J Bone Miner Res. 2010 Jan;25(1):72-81. doi: 10.1359/jbmr.090716.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwiński E, Bone HG, Wang C, Huang S, Chines A, Lems W, Brown JP. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020 Jan;31(1):181-191. doi: 10.1007/s00198-019-05233-x. Epub 2019 Nov 28.

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.

Reid IR, Miller PD, Brown JP, Kendler DL, Fahrleitner-Pammer A, Valter I, Maasalu K, Bolognese MA, Woodson G, Bone H, Ding B, Wagman RB, San Martin J, Ominsky MS, Dempster DW; Denosumab Phase 3 Bone Histology Study Group. Effects of denosumab on bone histomorphometry: the FREEDOM and STAND studies. J Bone Miner Res. 2010 Oct;25(10):2256-65. doi: 10.1002/jbmr.149.

• Responsible Party: Global Development Leader, Amgen Inc.
• ClinicalTrials.gov Identifier: NCT00377819
• Other Study ID Numbers: 20050234
• First Posted: September 18, 2006
• Results First Posted: August 3, 2010
• Last Update Posted: July 11, 2011
• Last Verified: June 2011

Keywords provided by Amgen:

RANKL; RANK; denosumab; AMG 162; osteoporosis; bone turnover; bone mineral density; clinical trial; postmenopausal osteoporosis; alendronate; total hip bone mineral density

Additional relevant MeSH terms:

Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Denosumab; Alendronate; Bone Density Conservation Agents; Physiological Effects of Drugs