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NCT Number: NCT00890981

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

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.

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Key information

Conditions

Low Bone Mass Bone Diseases Bone Diseases, Metabolic Low Bone Mineral Density Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal Postmenopausal Osteoporosis

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Dual energy X-ray absorptiometry (DXA)

Procedure

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

Denosumab

Biological

Denosumab 60 mg subcutaneously every 6 months in the previous study

Placebo

Drug

Placebo to denosumab subcutaneously every 6 months in the previous study

Primary outcomes

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

    Time frame: 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 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.

Secondary outcomes

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

    Time frame: 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 20050179 Baseline in total BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

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

    Time frame: 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 20050179 Baseline in cortical BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

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

    Time frame: 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 20050179 Baseline in trabecular BMD at the distal radius as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.

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

    Time frame: 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 20050179 Baseline in cortical thickness at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

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

    Time frame: 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 20050179 Baseline in total BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.

  6. Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT

    Time frame: 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 20050179 Baseline in cortical BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

  7. Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT

    Time frame: 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 20050179 Baseline in trabecular BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

  8. Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA

    Time frame: 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 of distal 1/3 radius BMD from the 20050179 Baseline as determined by dual energy X-ray absorptiometry (DXA) at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.

  9. Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA

    Time frame: 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 of ultradistal radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since last the subcutaneous dose of denosumab or placebo in study 20050179.

  10. Percent Change of Total Radius BMD From the Parent Study Baseline by DXA

    Time frame: 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 of total radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.

  11. Actual Value of Serum Type I C-telopeptide

    Time frame: Day 1

    Actual value of Serum Type I C-telopeptide measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).

  12. Actual Value of Procollagen Type 1 N-terminal Peptide

    Time frame: Day 1

    Actual value of Type 1 N-terminal Peptide as measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 30, 2009
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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