The purpose of this study is to assess to what extent sequential treatment with odanacatib results in incremental gains in bone mineral density (BMD) over time in female participants who have received at least 3 years of bisphosphonate therapy. It was hypothesized that odanacatib treatment would increase femoral neck BMD relative to placebo after 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
135
odanacatib 50 mg oral tablet
dose-matched placebo to odanacatib, oral tablet
Percent Change From Baseline to Month 12 in Femoral BMD
Dual-energy X-ray absorptiometry (DXA) was used to determine the change from baseline in femoral neck BMD at Month 12.
Time frame: Baseline and Month 12
Percent Change From Baseline to Month 24 in Femoral Neck BMD: Within-Group Comparison of Odanacatib
DXA was used to determine the within-group change from baseline in femoral neck BMD at Month 24.
Time frame: Baseline and Month 24
Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD
DXA was used to determine the change from baseline in trochanter, total hip, and lumbar spine BMD at Month 12.
Time frame: Baseline and Month 12
Change From Baseline in Serum C-telopeptides of Type 1 Collagen (s-CTx)
s-CTx is a biochemical marker of bone resorption. At baseline and Month 12, s-CTx was measured and expressed in ng/mL and results are expressed as percentage change from baseline.
Time frame: Baseline and Month 12
Change From Baseline in Urine C-telopeptides of Type I Collagen (u-CTx)
u-CTx is a biochemical marker of bone resorption. At baseline and Month 12, u-CTx was measured and expressed in ug/mL and results are expressed as percentage change from baseline.
Time frame: Baseline and Month 12
Change From Baseline in Urine N-telopeptides of Type 1 Collagen Corrected for Creatinine (u-NTx/Cr)
The u-NTx/Cr ratio is a biochemical marker of bone resorption. u-NTx/Cr was measured at baseline and Month 12 and expressed in nM:mM and results are expressed as percentage change from baseline.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline and Month 12
Change From Baseline in Serum Bone Specific Alkaline Phosphatase (s-BSAP)
s-BSAP is a biochemical marker of bone resorption. s-BSAP was measured and expressed in ng/mL at Baseline and Month 12, and results are shown as percentage change from baseline.
Time frame: Baseline and Month 12
Change From Baseline in Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)
s-P1NP is a biochemical marker of bone resorption. s-P1NP was measured and expressed as ng/mL at Baseline and Month 12, and results are expressed as percentage change from baseline.
Time frame: Baseline and Month 12