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Docosahexaenoic Acid (DHA) |
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Clinical Trial: Efficacy and Safety of Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women with Osteopenia, 45 Years of Age and Older.
This study is currently recruiting patients.
Verified by Novartis August 2005
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Purpose
Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.
| Condition | Intervention | Phase |
|---|---|---|
| Osteopenia (osteoporosis prevention) | Drug: Zoledronic Acid | Phase III |
MedlinePlus related topics: Bone Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A 2-Year Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Intravenous Zoledronic Acid 5 Mg Administered Either Annually at Randomization and 12 Months, or Administered at Randomization Only in the Prevention of Bone Loss in Postmenopausal Women with Osteopenia
Further Study Details:
Study start: July 2004
Eligibility
Ages Eligible for Study: 45 Years and above, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Postmenopausal
- Greater than or equal to 45 years of age
- Osteopenia (lumbar spine BMD T-score between -1.0 and -2.5, and
- BMD T-score > -2.5 at the femoral neck
Exclusion Criteria:
- Patients with more than one Grade 1 vertebral fracture (as per Genant method; patients with one Grade 1 vertebral fracture are eligible to participate)
- Patients with any Grade 2 or 3 vertebral fracture (as per Genant method)
- Patients with 25-(OH) Vitamin D levels less than 15 ng/mL prior to randomization
Other protocol-defined exclusion criteria may apply.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00132808
Novartis Pharmaceuticals 862-778-8300
New Jersey
For information regarding facilities, please contact the Central Contact, E. Hanover, New Jersey, 07936, United States; Recruiting
More Information
Study ID Numbers: CZOL446N2312
Last Updated: August 19, 2005
Record first received: August 18, 2005
ClinicalTrials.gov Identifier: NCT00132808
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 19, 2005
Record first received: August 18, 2005
ClinicalTrials.gov Identifier: NCT00132808
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
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