DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postmenopausal Osteoporosis

Intervention: Ibandronate (Drug); Denosumab (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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 about 65 sites in a 1: 1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Total Hip Bone Mineral Density Percent Change From Baseline at Month 12

Secondary outcome:

Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1

Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12

Eligibility

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: July 2009
Last updated: February 5, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017