EUCTR2006-000849-19-ITActive, not recruitingNot Applicable
A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy from Alendronate to Denosumab AMG 162 in Postmenopausal Women with Low Bone Mineral Density - STAND
AMGEN S.P.A.0 sites500 target enrollmentStarted: January 30, 2007Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Ambulatory postmenopausal women, with BMD g/cm2 values that correspond to a T-score 8804; -2.0 and 8805;-4.0 at the lumbar spine or total hip. Subjects must have received alendronate treatment of 70 mg/wk or equivalent for at least 6 months prior to screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •unstable hyper or hypothyroidism; hypo or hyperparathyroidism; epatic or renal impairment; hypo or hypercalcemia; acute gastric or duodenal ulcer or history of gastrointestinal bleed; reumatoid arthritis, Paget s disease, Cushing s disease, cirrhosis of the liver, hyperprolactinemia, positive test for HIV, hepatitis C or B, malignancies within the last 5 years, malabsorption syndrome.
Investigators
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