A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab

NCT ID: NCT00890981

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-08-31

Brief Summary

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). Participants randomized to either denosumab or placebo in the 20050179 (NCT00293813) study who completed that study (ie, attended an end of study visit) can be included in this study. At least 12 months should have elapsed since the patient's 20050179 end of study visit.

Conditions

Low Bone Mass; Low Bone Mineral Density; Osteoporosis; Postmenopausal Osteoporosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm 1

Participants who were randomized to either denosumab or placebo in Study 20050179 and at least 12 months had elapsed from their 20050179 end-of-study visit had dual energy X-ray absorptiometry (DXA) of the forearm and HR-pQCT of the tibia and radius on Day 1 of this study. No study drug was administered.

Group Type: OTHER

high-resolution peripheral quantitative computed tomography (HR-pQCT)

Intervention Type: PROCEDURE

Bone densitometry and microarchitecture assessments of the distal radius and the distal tibia by HR-pQCT on Day 1.

Dual energy X-ray absorptiometry (DXA)

Intervention Type: PROCEDURE

Bone densitometry assessments of the forearm by DXA on day 1.

Denosumab

Intervention Type: BIOLOGICAL

Denosumab 60 mg subcutaneously every 6 months in the previous study

Placebo

Intervention Type: DRUG

Placebo to denosumab subcutaneously every 6 months in the previous study

Interventions

high-resolution peripheral quantitative computed tomography (HR-pQCT)

Bone densitometry and microarchitecture assessments of the distal radius and the distal tibia by HR-pQCT on Day 1.

Intervention Type: PROCEDURE

Dual energy X-ray absorptiometry (DXA)

Bone densitometry assessments of the forearm by DXA on day 1.

Intervention Type: PROCEDURE

Denosumab

Denosumab 60 mg subcutaneously every 6 months in the previous study

Intervention Type: BIOLOGICAL

Placebo

Placebo to denosumab subcutaneously every 6 months in the previous study

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Ambulatory, postmenopausal women
• Randomized to either denosumab or placebo in the 20050179 (NCT00293813) study and completed that study (ie, 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).

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

concept.747 Treatment/discontinuation on wrist.Journal-004521;

Reference Type: BACKGROUND

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20080747

Identifier Type: -

Identifier Source: org_study_id