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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120600
• Other study ID #: 0822-053
• Secondary ID: 2010_532
• Status: Completed
• Phase: Phase 3
• Start date: June 9, 2010
• Est. completion date: July 22, 2013

Study information

• Verified date: July 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: July 22, 2013
• Est. primary completion date: July 22, 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Odanacatib
One 50 mg tablet once weekly
• Placebo for Odanacatib
One 50 mg tablet once weekly

Dietary Supplement:
• Vitamin D3
5600 IU of open-label Vitamin D3 once weekly
• Calcium carbonate
Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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