Osteopenia refers to bones that have become somewhat less dense than normal, but the bone loss is not as severe as in osteoporosis. A person with osteopenia is at risk for getting osteoporosis.

This is a study in postmenopausal women with osteopenia. The study will examine the effect on the bone mineral density (BMD) of the lumbar spine following one-year of treatment with 150mg oral ibandronate given once monthly. Participants will be randomly (by chance) assigned to two treatment groups. One group will receive 150mg oral ibandronate monthly and the other group will received placebo (has the appearance of drug, but no active ingredient) monthly.

Condition	Intervention	Phase
Bone Disease, Metabolic Osteopenia	Drug: BONIVA [ibandronate sodium]	Phase IV

Ages Eligible for Study:  45 Years   -   60 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

• Postmenopausal women between 45 and 60 years of age
• Postmenopausal women with a bone mineral density (BMD) T-score less than 1.0 and greater than 2.5 at lumbar spine
• Patients who are ambulatory (able to walk) at the beginning of the trial and have no expectation to become hospitalized, immobilized, or bedridden during the course of the trial
• Patients who are willing and able to follow the requirements of the study
• Patients who provide written informed consent

Exclusion Criteria:

• Treatment with any bisphosphonate during 2 years before start of study
• Administration of any investigational drug within 30 days
• Disease or disorder known to influence bone metabolism
• Treatment with drugs within the last 6 months affecting bone metabolism
• Severe kidney failure
• Presence of a fractured vertebra found at screening x-ray
• History of breast cancer diagnosed within the past 20 years
• History of other cancer diagnosed within the past 10 years (a successfully treated basal cell carcinoma, a type of skin cancer, does not exclude patient)
• Receiving any investigational drug within 30 days before the first dose of the study drug
• Certain gastrointestinal or liver diseases

Please refer to this study by ClinicalTrials.gov identifier  NCT00129623

Please reference Study ID Number: PDO_BA18492      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

Colorado
      Lakewood,  Colorado,  80227,  United States
Florida
      Lake Worth,  Florida,  33461,  United States
      Stuart,  Florida,  34996,  United States
Maryland
      Bethesda,  Maryland,  20817,  United States
Michigan
      Detroit,  Michigan,  48236,  United States
Missouri
      St. Louis,  Missouri,  63110,  United States
Montana
      Billings,  Montana,  59101,  United States
Nebraska
      Omaha,  Nebraska,  68131,  United States
New Mexico
      Albuquerque,  New Mexico,  87106,  United States
Oregon
      Portland,  Oregon,  97213,  United States
Pennsylvania
      Wyomissing,  Pennsylvania,  19610,  United States
      Doylestown,  Pennsylvania,  18901,  United States
Virginia
      Richmond,  Virginia,  23294,  United States
      Norfolk,  Virginia,  23502,  United States

Study ID Numbers:  BA18492
Last Updated:  August 11, 2005
Record first received:  August 11, 2005
ClinicalTrials.gov Identifier:  NCT00129623
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23