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Clinical Trials/EUCTR2006-000849-19-IT
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

Sponsor
AMGEN S.P.A.

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