The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.
The original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and participants will then remain in the study for an additional 12 months (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the Month 36 BMD analysis was deleted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
294
One 50 mg tablet once weekly
One 50 mg tablet once weekly
5600 IU of open-label Vitamin D3 once weekly
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24
Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.
Time frame: Baseline and Month 24
Number of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Time frame: Up to 24 months (plus 14 days) after first dose of study drug
Number of Participants Who Discontinued Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Time frame: Up to 24 months after first dose of study drug
Percentage Change From Baseline in Total Hip BMD at Month 24
Total hip BMD was assessed by DXA at Baseline and at Month 24.
Time frame: Baseline and Month 24
Percentage Change From Baseline in Femoral Neck BMD at Month 24
Femoral Neck BMD was assessed by DXA at Baseline and at Month 24.
Time frame: Baseline and Month 24
Percentage Change From Baseline in Trochanter BMD at Month 24
Trochanter BMD was assessed by DXA at Baseline and at Month 24.
Time frame: Baseline and Month 24
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Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg
Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24
Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24.
Time frame: Baseline and Month 24
Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24
Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24.
Time frame: Baseline and Month 24
Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24
Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24.
Time frame: Baseline and Month 24
Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24
Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24.
Time frame: Baseline and Month 24