A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)

A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) in the Treatment of Men With Osteoporosis Treated With Vitamin D and Calcium

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Odanacatib; Dietary supplement: Vitamin D3; Dietary supplement: Calcium carbonate; Drug: Placebo for Odanacatib

Detailed Description

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
• Enrollment (Actual): 294
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Is a male between 40 and 95 years of age
• Has osteoporosis
• Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar spine and and hip
• Is ambulatory

Exclusion Criteria:

• Is currently on oral bisphosphonates or other treatment for osteoporosis
• Had previous hip fragility fracture and is a candidate for standard of care therapy
• Has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced bone strength) within 12 months
• Has had more then one previous vertebral fracture
• Has been diagnosed with metabolic bone disorder other than osteoporosis
• Is Vitamin D deficient
• Has a history of renal stones
• Has active parathyroid disease
• Has history of thyroid disease not well controlled by medication
• Is diagnosed with secondary osteoporosis
• Has a daily calcium intake of <1,200 mg and is unwilling to take study prescribed supplements or increase dietary intake, such that his daily calcium intake is at least 1200 mg
• Has a history of malignancy ≤5 years prior to signing informed consent
• Has been diagnosed with hypogonadism due to causes that affect multiple organ and body systems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Odanacatib 50 mg once weekly; Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.	Drug: Odanacatib; One 50 mg tablet once weekly; Other Names: MK-0822; Dietary supplement: Vitamin D3; 5600 IU of open-label Vitamin D3 once weekly; Dietary supplement: Calcium carbonate; Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg
Placebo Comparator: Placebo once weekly; Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.	Dietary supplement: Vitamin D3; 5600 IU of open-label Vitamin D3 once weekly; Dietary supplement: Calcium carbonate; Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg; Drug: Placebo for Odanacatib; One 50 mg tablet once weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to 24 months after first dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change From Baseline in Total Hip BMD at Month 24	Total hip BMD was assessed by DXA at Baseline and at Month 24.	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.	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.	Baseline and Month 24
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.	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.	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.	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.	Baseline and Month 24

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Binkley N, Orwoll E, Chapurlat R, Langdahl BL, Scott BB, Giezek H, Santora AC. Randomized, controlled trial to assess the safety and efficacy of odanacatib in the treatment of men with osteoporosis. Osteoporos Int. 2021 Jan;32(1):173-184. doi: 10.1007/s00198-020-05701-9. Epub 2020 Nov 17.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2010
• Primary Completion (Actual): July 22, 2013
• Study Completion (Actual): July 22, 2013

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: May 7, 2010
• First Posted (Estimate): May 11, 2010

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Antacids; Vitamin D; Cholecalciferol; Calcium; Calcium Carbonate
• Other Study ID Numbers: 0822-053; 2010_532 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No