A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab
Condition: Low Bone Mass; Low Bone Mineral Density; Osteoporosis; Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic
Intervention: high-resolution peripheral quantitative computed tomography (HR-pQCT); Dual energy X-ray absorptiometry (DXA); Denosumab; Placebo
Intervention description: Bone densitometry and microarchitecture assessments of the distal radius and the distal tibia by HR-pQCT on Day 1.; Bone densitometry assessments of the forearm by DXA on day 1.; Denosumab 60 mg subcutaneously every 6 months in the previous study; Placebo to denosumab subcutaneously every 6 months in the previous study
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: Female
Healthy volunteers: No

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.
    

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).