Do You Have Osteoporosis?

  • STATUS
    Recruiting
Updated on 8 November 2020
Investigator
Mayu Frank
Primary Contact

Summary

Do You Have Osteoporosis?

Description

Currently looking for women who:

  • Are 55 years or older and prescribed a daily or weekly medication for osteoporosis
  • Have stopped using osteoporosis medication, or have not taken osteoporosis medication as prescribed by their doctor
  • Are willing to participate in a 12-month study
Your participation in a study could help osteoporosis research. After menopause, many women lose bone strength, a condition called osteoporosis. Osteoporosis can increase the risk for fractures. Some women who are being treated have difficulty following the medication plan prescribed by their doctor, and may not receive the full benefit of their medication. You could participate in research that will examine an investigational medication for osteoporosis. Qualified volunteers will receive study-related bone density measurements, laboratory tests, and a study medication at no cost. Study medication is taken once a month or once every 6 months.

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

Details
Clinical Study IdentifierTX134940
Last Modified on8 November 2020

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