Study of Transitioning From Alendronate to Denosumab - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00377819

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 III

MedlinePlus related topics: Minerals Osteoporosis

Drug Information available for: Alendronate Alendronate sodium Denosumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Amgen:

Primary Outcome Measures:

Change in total hip BMD over one year. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in BMD at the spine, forearm and other hip locations. Change in bone turnover markers including CTX, BSAP P1NP and uNTX. Effect on serum calcium. Analysis of adverse events. Effect on bone histology and histomorphometry in a subset of patients. [ Time Frame: One Year ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
denosumab: Experimental	Drug: Denosumab (AMG 162) 60 mg SC q 6 mos
alendronate: Active Comparator	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 BMD corresponding to T-score ≤ -2 and ≥ -4

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Exclusion Criteria: Vitamin D deficiency. Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate. Administration of PTH or PTH derivatives (eg; teriparatide) within the last year. Administration of any bisphosphonate other than 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

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

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050234
Study First Received:	September 14, 2006
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00377819
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

Study placed in the following topic categories:

Musculoskeletal Diseases
Alendronate
Osteoporosis, Postmenopausal

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009