Osteoporosis |
Bone Loss |
Clinical Trial: A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis
This study is not yet open for patient recruitment.
|
Purpose
This is a 2 year study to examine the effects of a new experimental medication on postmenopausal osteoporosis. This study will enroll approximately 375 postmenopausal women, and randomly assign them to 4 different doses of the test drug or to placebo. Measurements performed during the study include: bone mineral density scans, spine x-rays, laboratory blood and urine tests, height measurements and optional bone biopsy (at the end of 2 years).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Osteoporosis | Drug: Investigational drug for the treatment of postmenopausal osteoporosis | Phase II Phase III |
MedlinePlus related topics: Osteoporosis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Ages Eligible for Study: 45 Years - 85 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Postmenopausal for 5 or more years.
- Bone mineral density (BMD) T-score at the hip or spine of -2.0 or less.
- In a state of general health allowing for successful completion of the trial.
- Agreement to not use any medications to treat osteoporosis during the study.
Exclusion Criteria:
- History of prior osteoporotic fracture (unless declined treatment with or was ineligible for osteoporosis therapy).
- Past treatment with osteoporosis medications, steroids, hormone replacement, as well as various other medications that affect bone may be exclusionary. (Different exclusion criteria apply to each bone active drug. For example, any prior use of intravenous (IV) bisphosphonates is not permitted. By contrast, prior use of hormone replacement for several years is permitted if it has not occurred within the past 6 months. Please ask the study doctor for details).
Location and Contact Information
More Information
Record last reviewed: June 2005
Last Updated: June 2, 2005
Record first received: June 2, 2005
ClinicalTrials.gov Identifier: NCT00112437
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-06-07

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