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Completed

NCT Number: NCT01120600

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

40 year–95 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

odanacatib

Drug

One 50 mg tablet once weekly

Other names: MK-0822

Placebo for Odanacatib

Drug

One 50 mg tablet once weekly

Vitamin D3

Dietary Supplement

5600 IU of open-label Vitamin D3 once weekly

Calcium Carbonate

Dietary Supplement

Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg

Primary outcomes

  1. Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24

    Time frame: Baseline and Month 24

    Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.

  2. Number of Participants Who Experienced an Adverse Event (AE)

    Time frame: Up to 24 months (plus 14 days) after first dose of study drug

    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.

  3. Number of Participants Who Discontinued Treatment Due to an AE

    Time frame: Up to 24 months after first dose of study drug

    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.

Secondary outcomes

  1. Percentage Change From Baseline in Total Hip BMD at Month 24

    Time frame: Baseline and Month 24

    Total hip BMD was assessed by DXA at Baseline and at Month 24.

  2. Percentage Change From Baseline in Femoral Neck BMD at Month 24

    Time frame: Baseline and Month 24

    Femoral Neck BMD was assessed by DXA at Baseline and at Month 24.

  3. Percentage Change From Baseline in Trochanter BMD at Month 24

    Time frame: Baseline and Month 24

    Trochanter BMD was assessed by DXA at Baseline and at Month 24.

  4. Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24

    Time frame: Baseline and Month 24

    Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24.

  5. Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24

    Time frame: Baseline and Month 24

    Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24.

  6. Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24

    Time frame: Baseline and Month 24

    Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24.

  7. Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24

    Time frame: Baseline and Month 24

    Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 11, 2010
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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