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
Overview
- Phase
- Phase 2
- Intervention
- Odanacatib
- Conditions
- Osteoporosis
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 246
- Primary Endpoint
- Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Has been postmenopausal for at least 5 years
- •Has taken or is taking alendronate
- •Agrees not to use medications for osteoporosis other than what is provided by the study
Exclusion Criteria
- •Has a history or evidence of hip fracture
- •Has a history of cancer within 5 years of screening, except certain skin or cervical cancers.
- •Has active parathyroid disease
- •Has a history of thyroid disease not adequately controlled by medication
- •Is taking anti-seizure medication and has abnormal calcium metabolism
- •Has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening
Arms & Interventions
Odanacatib 50 mg
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Intervention: Odanacatib
Odanacatib 50 mg
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Intervention: Vitamin D3
Odanacatib 50 mg
Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Intervention: Calcium
Placebo
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Intervention: Placebo
Placebo
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Intervention: Vitamin D3
Placebo
Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Intervention: Calcium
Outcomes
Primary Outcomes
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24
Time Frame: Baseline and Month 24
BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.
Percentage of Participants Discontinuing Study Drug Due to an AE
Time Frame: Up to 24 months
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Percentage of Participants Experiencing One or More Adverse Events (AEs)
Time Frame: Up to 25 months
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Secondary Outcomes
- Percent Change From Baseline in Lumbar Spine BMD at Month 24(Baseline and 24 Months)
- Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24(Baseline and Month 24)
- Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24(Baseline and Month 24)
- Percent Change From Baseline in Lumbar Spine BMD at Month 12(Baseline and 12 Months)
- Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12(Baseline and 12 Months)
- Percent Change From Baseline in Log-Transformed s-CTx at Month 12(Baseline and Month 12)
- Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24(Baseline and Month 24)
- Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12(Baseline and Month 12)
- Percent Change From Baseline in Femoral Neck BMD at Month 12(Baseline and 12 Months)
- Percent Change From Baseline in Total Hip BMD at Month 24(Baseline and 24 Months)
- Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24(Baseline and Month 24)
- Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24(Baseline and Month 24)
- Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24(Baseline and Month 24)
- Percent Change From Baseline in Trochanter BMD at Month 24(Baseline and 24 Months)
- Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24(Baseline and 24 Months)
- Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24(Baseline and Month 24)
- Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24(Baseline and Month 24)
- Percent Change From Baseline in Trochanter BMD at Month 12(Baseline and 12 Months)
- Percent Change From Baseline in Total Hip BMD at Month 12(Baseline and 12 Months)
- Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12(Baseline and Month 12)
- Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24(Baseline and Month 24)
- Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12(Baseline and Month 12)