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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-008257-30-ES

Enrollment

160

Registered

2009-01-20

Start date

2009-03-31

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis MedDRA version: 9.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal

Interventions

Product Name: MK-0822

Chemical name: N1-(1-cyanocyclopropyl)-4-fluoro-N2-{(1S)-2,2,2-trifluoro-1-[4?-(methylsulfo Product Code: MK-0822 Pharmaceutical Form: Tablet INN or Pro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: >= 60 yrs of age, postmenopausal >= 5 yrs, Prior use of ALN for >= 3 yrs, and BMD t-score at hip -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 -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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of treatment on BMD percent change from baseline at the femoral neck site assessed by DXA compared to placebo at the end of 24 months.;Secondary Objective: To evaluate the effect of treatment on BMD percent change from baseline at the trochanter, total hip, lumbar spine and 1/3 distal radius sites assessed by DXA compared to placebo at the end of 24 months. Also, to evaluate the effect of treatment on biochemical markers of bone turnover compared to placebo, and within each treatment group, at the end of 24 months. In addition to evaluate these measurements compared to placebo, and within each treatment group, at the end of 12 months.;Primary end point(s): BMD at hip	—

Measure

Time frame

Main Objective: To evaluate the effect of treatment on BMD percent change from baseline at the femoral neck site assessed by DXA compared to placebo at the end of 24 months.;Secondary Objective: To evaluate the effect of treatment on BMD percent change from baseline at the trochanter, total hip, lumbar spine and 1/3 distal radius sites assessed by DXA compared to placebo at the end of 24 months. Also, to evaluate the effect of treatment on biochemical markers of bone turnover compared to placebo, and within each treatment group, at the end of 24 months. In addition to evaluate these measurements compared to placebo, and within each treatment group, at the end of 12 months.;Primary end point(s): BMD at hip

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Countries

Belgium, Czech Republic, France, Germany, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026