Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates
Lead Sponsor:
Amgen
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
55+ years
Phase:
PHASE3
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
833 Patients enrolled
Trial Details
Trial ID
NCT00936897
Start Date
July 1 2009
End Date
January 1 2012
Last Update
February 11 2013
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