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

NCT00890981 | Completed Phase 3 Results

• 1 other identifier: 20080747
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT

  Percent change from the 20050179 Baseline in cortical thickness at the distal radius as determined by high-resolution peripheral quantitative computed tomography (HR-pQCT) at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

  Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Secondary Outcomes (12)

• Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT

  Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

• Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT

  Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

• Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT

  Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

• Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT

  Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

• Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT

  Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.

Study Arms (1)

Arm 1

OTHER

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.

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

Interventions

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

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

Arm 1

Dual energy X-ray absorptiometry (DXA) PROCEDURE

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

Arm 1

Denosumab BIOLOGICAL

Denosumab 60 mg subcutaneously every 6 months in the previous study

Arm 1

Placebo DRUG

Placebo to denosumab subcutaneously every 6 months in the previous study

Arm 1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

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

  BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal

Interventions

Absorptiometry, Photon; Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 30, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 2, 2014
• Results First Posted: July 28, 2011

Record last verified: 2014-03