Study of Transitioning From Alendronate to Denosumab - Full Text View

Purpose

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	Intervention	Phase
Postmenopausal Osteoporosis	Drug: alendronate Drug: Denosumab (AMG 162)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Minerals Osteoporosis

Drug Information available for: Alendronate sodium Denosumab

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Percent Change From Baseline in Total Hip Bone Mineral Density [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
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:

Percent Change From Baseline in Lumbar Spine Bone Mineral Density [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.
Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I) [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100.

Enrollment:	504
Study Start Date:	September 2006
Study Completion Date:	July 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: denosumab	Drug: Denosumab (AMG 162) 60 mg SC q 6 mos
Active Comparator: alendronate	Drug: alendronate 70 mg oral QW

Eligibility

Ages Eligible for Study:	55 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377819

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

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.

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

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. 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.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00377819 History of Changes
Other Study ID Numbers:	20050234
Study First Received:	September 14, 2006
Results First Received:	July 1, 2010
Last Updated:	June 30, 2011
Health Authority:	Canada: Health Canada Estonia: State Agency of Medicines France: Ministry of Health Italy: Ministry of Health Poland: Drug Institut Portugal: National Institute of Pharmacy and Medicines United States: Food and Drug Administration United States: Institutional Review Board

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

Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013