A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)

Merck Sharp & Dohme LLC246 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

246

Conditions

Osteoporosis

Interventions

OdanacatibDRUG

Odanacatib 50 mg tablets once weekly for 24 months

PlaceboDRUG

Placebo to odanacatib 50 mg tablets once weekly for 24 months

Vitamin D3DIETARY_SUPPLEMENT

Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months

Eligibility

Sex: FEMALEMin age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24

BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.

Time frame: Baseline and Month 24

Percentage of Participants Experiencing One or More Adverse Events (AEs)

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.

Time frame: Up to 25 months

Percentage of Participants Discontinuing Study Drug Due to an AE

Time frame: Up to 24 months

Secondary Outcomes

Percent Change From Baseline in Femoral Neck BMD at Month 12

BMD at the femoral neck was assessed by DXA at baseline and Month 12.

Time frame: Baseline and 12 Months

Percent Change From Baseline in Trochanter BMD at Month 24

BMD at the trochanter was assessed by DXA at baseline and Month 24.

Time frame: Baseline and 24 Months

Percent Change From Baseline in Trochanter BMD at Month 12

BMD at the trochanter was assessed by DXA at baseline and Month 12.

Time frame: Baseline and 12 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Percent Change From Baseline in Total Hip BMD at Month 24

BMD at the total hip was assessed by DXA at baseline and Month 24.

Time frame: Baseline and 24 Months

Percent Change From Baseline in Total Hip BMD at Month 12

BMD at the total hip was assessed by DXA at baseline and Month 12.

Time frame: Baseline and 12 Months

Percent Change From Baseline in Lumbar Spine BMD at Month 24

BMD at the lumbar spine was assessed by DXA at baseline and Month 24.

Time frame: Baseline and 24 Months

Percent Change From Baseline in Lumbar Spine BMD at Month 12

BMD at the lumbar spine was assessed by DXA at baseline and Month 12.

Time frame: Baseline and 12 Months

Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24

BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24.

Time frame: Baseline and 24 Months

Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12

BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12.

Time frame: Baseline and 12 Months

Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24

s-CTx is a biochemical marker of bone resorption.

Time frame: Baseline and Month 24

Percent Change From Baseline in Log-Transformed s-CTx at Month 12

s-CTx is a biochemical marker of bone resorption.

Time frame: Baseline and Month 12

Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24

N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (u-NTx/Cr) is a biochemical marker of bone resorption.

Time frame: Baseline and Month 24

Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12

u-NTx/Cr is a biochemical marker of bone resorption.

Time frame: Baseline and Month 12

Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24

Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation.

Time frame: Baseline and Month 24

Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12

BSAP is a biochemical marker of bone formation.

Time frame: Baseline and Month 12

Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24

Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation.

Time frame: Baseline and Month 24

Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12

s-P1NP is a biochemical marker of bone formation.

Time frame: Baseline and Month 12

Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24

Serum calcium is an index of calcium homeostasis.

Time frame: Baseline and Month 24

Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24

Serum phosphate is an index of mineral homeostasis.

Time frame: Baseline and Month 24

Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24

Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood.

Time frame: Baseline and Month 24

Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24

1,25 dihydroxyvitamin D \[1,25(OH)2 D\] is the active vitamin D metabolite and stimulates calcium absorption in the intestine.

Time frame: Baseline and Month 24

Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24

The 25-hydroxy vitamin D \[25(OH)D\] test is the most accurate way to measure vitamin D. In the kidney, 25-hydroxy vitamin D is converted into 1,25 di-hydroxyvitamin D, the active vitamin D metabolite.

Time frame: Baseline and Month 24