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
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.
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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