A HR-pQCT Study in Postmenopausal Women Previously Treated With Denosumab - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00890981

Purpose

To evaluate the combined effect of denosumab treatment and discontinuation on cortical thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT). Subjects randomized to either denosumab or placebo in the 20050179 study who completed that study (ie, the subject attended an end of study visit) can be included in this study. At least 12 months should have elapsed since the subject's 20050179 end of study visit

Condition	Intervention	Phase
Low Bone Mass Low Bone Mineral Density Osteoporosis Postmenopausal Osteoporosis	Procedure: HR-pQCT, DXA and BTM measurements	Phase III

MedlinePlus related topics: Osteoporosis

Drug Information available for: Denosumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A HR-pQCT Study in Postmenopausal Women Previously Treated With Denosumab

Further study details as provided by Amgen:

Primary Outcome Measures:

The primary endpoint is the percent change from the 20050179 baseline in cortical thickness at the distal radius as determined by HR-pQCT (the baseline was established in the protocol 20050179). [ Time Frame: Day 1 compared to baseline in 20050179 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

HR-pQCT parameters at: the distal radius (total BMD, cortical BMD, trabecular BMD), the tibia (cortical thickness, cortical BMD, total BMD and trabecular BMD) and 1/3 radius, ultradistal radius and total radius BMD as determined by DXA [ Time Frame: Percent Change from baseline in 20050179 to Day 1 ] [ Designated as safety issue: Yes ]
BTM [Procollagen type 1 amino-terminal propeptide (P1NP) and C-Telopeptide Type 1 (CTX-1)] [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	June 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1	Procedure: HR-pQCT, DXA and BTM measurements Subjects who sign the informed consent will undergo HR-pQCT and DXA measurements. The study will consist of one visit for screening, enrollment and completion of study procedures (DXA, HR-pQCT and BTM). No study drug will be administered during the course of the study.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ambulatory, postmenopausal women
Randomized to either denosumab or placebo in the 20050179 study and completed that study (ie, the subject attended an end of study visit)
At least 12 months have elapsed since their end of 20050179 study visit
Provide signed informed consent

Exclusion Criteria:

Subjects who failed to receive both doses of denosumab (or SQ [subcutaneous] placebo) during the 20050179 study
Subjects who were randomized to the alendronate arm during the 20050179 study
Subjects diagnosed with any of the following conditions following completion of the 20050179 study:
Hyperthyroidism
Hyperparathyroidism
Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy
Other diseases which affect bone metabolism
Self-reported alcohol or drug abuse within the previous 12 months
Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
Received any investigational product other than denosumab in two years before the screening visit.
Received > 3 months (or equivalent) of osteoporosis treatment since having completed the 20050179 study.
Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone.
Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s) (other than Amgen trial 20080287), or subject is receiving other investigational agent(s).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890981

Contacts

Contact: Amgen Call Center

866-572-6436

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

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

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20080747
Study First Received:	April 23, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00890981 History of Changes
Health Authority:	Argentina: Ministry of Health; Canada: Health Canada; United States: Food and Drug Administration; Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica)

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on May 07, 2009