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Clinical Trials/EUCTR2008-008257-30-ES
EUCTR2008-008257-30-ES
Active, not recruiting
Phase 1

Estudio en fase IIa aleatorizado, doble ciego, controlado con placebo para evaluar los efectos de odanacatib (MK-0822) sobre la densidad mineral ósea (DMO) y la seguridad general en el tratamiento de la osteoporosis en mujeres posmenopáusicas previamente tratadas con alendronato A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated with Alendronate - Odanacatib

Merck & Co., Inc.0 sites160 target enrollmentJanuary 20, 2009

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
Merck & Co., Inc.
Enrollment
160
Status
Active, not recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 20, 2009
End Date
September 15, 2011
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • \>\= 60 yrs of age, postmenopausal \>\= 5 yrs, Prior use of ALN for \>\= 3 yrs, and BMD t\-score at hip \<\=\-2\.5 and \>\-3\.5 as assessed by DXA without a history of prior fracture (patients with a prior fracture, excluding hip, the BMD t\-score can be \<\=\-1\.5 and \>\-3\.5 at any hip site).
  • 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) no
  • F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • History or evidence of hip fracture, active parathyroid disease, and patient received prior treatment for osteoporosis other than ALN.

Outcomes

Primary Outcomes

Not specified

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