A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

February 5, 2013 updated by: Amgen

A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women. Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

833

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Ambulatory, postmenopausal women (based on medical history) 55 years or older at screening
  • Postmenopause will be defined as no vaginal bleeding or spotting for at least 12 months
  • If the subject is 55 - 59 years old and there is uncertainty regarding menopausal status, confirmation of serum FSH (>= 50 mIU/mL) and serum estradiol (<= 20 pg/mL) must be obtained
  • If the subject is 60 years or older, evaluation of FSH and estradiol levels is not needed to confirm menopausal status
  • Have received their first prescription of daily or weekly bisphosphonate therapy at least 1 month prior to screening
  • May have received
  • raloxifene, calcitonin, prior to initiation of daily orweekly bisphosphonate therapy.
  • up to 3 doses of monthly bisphosphonate prior to initiation of daily or weekly bisphosphonate therapy
  • calcium, and vitamin D
  • Hormone replacement therapy (e.g. estrogen use for mitigation of menopausal symptoms)
  • Subject has:
  • Stopped daily or weekly bisphosphonate therapy (is denoted as non-persistent) at least one month before the screening visit, or
  • Demonstrated low adherence to therapy assessed by a score of less than 6 on the OS-MMAS
  • Screening BMD (g/cm2) values, at the lumbar spine OR total hip, that occur within the following ranges, based on the particular scanner that is used:

GE Lunar Lumbar spine 0.700 < or = BMD < and = 0.940 Total hip 0.504 < or = BMD < or = 0.756

Hologic Lumbar spine 0.607 < or = BMD < or = 0.827 Total hip 0.454 < or = BMD < or = 0.698 Both the initial and the repeat DXA scan of the lumbar spine OR the total hip must meet the above eligibility criteria.

  • At least 2 lumbar vertebrae must be evaluable by DXA.
  • At least one hip must be evaluable by DXA (eg, no history of either bilateral hip replacement or pins in both hips)
  • Provide signed informed consent before any study-specific procedures are conducted

Exclusion Criteria:

  • Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
  • Current or prior use of medications prescribed for osteoporosis treatment other than oral daily or weekly bisphosphonate
  • Contraindicated to receive oral ibandronate 150mg PO QM, including
  • Hypersensitivity to ibandronate 150mg PO QM or other constituents of ibandronate 150mg PO QM tablets
  • Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia
  • Inability to stand or sit upright for at least 60 minutes
  • Administration of any of the following treatments within 3 months of screening
  • Tibolone
  • Anabolic steroids or testosterone
  • Glucocorticosteroids (>= 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of >= 50 mg)
  • Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (<49.9 nmol/L)] - Repletion will be allowed and subjects may be re-screened
  • Evidence of any of the following per subject report, chart review or central laboratory result:
  • Significantly impaired renal function as determined by estimated Glomerular Filtration Rate less that 30mL/min/1.73 m2 determined by the central laboratory
  • Current hypo- or hypercalcemia based on the central laboratory reference ranges
  • Active gastric or duodenal ulcer; or any history of significant gastrointestinal bleed requiring hospitalization or transfusion
  • Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
  • Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years
  • Any metabolic bone disease or secondary cause of bone loss that is not controlled and may interfere with the interpretation of the findings
  • Previous participation in clinical trials with denosumab 60mg SC Q6M (regardless of treatment)
  • Received any solid organ or bone marrow transplant
  • Any laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results
  • Known sensitivity to mammalian cell derived drug products
  • Known intolerance to calcium supplements
  • Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s)
  • Any physical or psychiatric disorder which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results
  • Evidence of alcohol or substance-abuse within the last 12 months which the investigator believes would interfere with understanding or completing the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ibandronate
Ibandronate 150mg PO QM (tablet)
Drug: Ibandronate
Ibandronate 150mg PO QM (tablet)
Experimental: Denosumab
denosumab 60mg Subcutaneous Q6M (pre-filled syringe)
Drug: Denosumab
denosumab 60mg SC Q6M (pre-filled syringe)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
Time Frame: Baseline to month 12
Baseline to month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1
Time Frame: Baseline to month 1
Baseline to month 1
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12
Time Frame: Baseline to Month 12
Baseline to Month 12
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Time Frame: Baseline to month 12
Baseline to month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (Estimate)

July 10, 2009

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20080562

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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