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

Amgen

Status and phase: Completed; Phase 3

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

Treatments: Procedure: high-resolution peripheral quantitative computed tomography (HR-pQCT); Drug: Placebo; Procedure: Dual energy X-ray absorptiometry (DXA); Biological: Denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00890981

20080747

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: Female

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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79 participants in 1 patient group

Arm 1

Other group

Description:

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.

Treatment:

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

Drug: Placebo

Procedure: Dual energy X-ray absorptiometry (DXA)

Biological: Denosumab