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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Odanacatib
Placebo
Vitamin D3
Calcium
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Odanacatib 50 mg

    Placebo

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    Percentage of Participants Discontinuing Study Drug Due to an AE
    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 Outcome Measures

    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.
    Percent Change From Baseline in Trochanter BMD at Month 24
    BMD at the trochanter was assessed by DXA at baseline and Month 24.
    Percent Change From Baseline in Trochanter BMD at Month 12
    BMD at the trochanter was assessed by DXA at baseline and Month 12.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    Percent Change From Baseline in Log-Transformed s-CTx at Month 12
    s-CTx is a biochemical marker of bone resorption.
    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.
    Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12
    u-NTx/Cr is a biochemical marker of bone resorption.
    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.
    Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12
    BSAP is a biochemical marker of bone formation.
    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.
    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.
    Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24
    Serum calcium is an index of calcium homeostasis.
    Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24
    Serum phosphate is an index of mineral homeostasis.
    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.
    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.
    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.

    Full Information

    First Posted
    April 20, 2009
    Last Updated
    July 30, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00885170
    Brief Title
    A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 13, 2009 (Actual)
    Primary Completion Date
    September 15, 2011 (Actual)
    Study Completion Date
    September 15, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    246 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Odanacatib 50 mg
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    Odanacatib
    Intervention Description
    Odanacatib 50 mg tablets once weekly for 24 months
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo to odanacatib 50 mg tablets once weekly for 24 months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamin D3
    Intervention Description
    Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Calcium
    Intervention Description
    Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24
    Description
    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
    Title
    Percentage of Participants Experiencing One or More Adverse Events (AEs)
    Description
    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
    Title
    Percentage of Participants Discontinuing Study Drug Due to an AE
    Description
    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 24 months
    Secondary Outcome Measure Information:
    Title
    Percent Change From Baseline in Femoral Neck BMD at Month 12
    Description
    BMD at the femoral neck was assessed by DXA at baseline and Month 12.
    Time Frame
    Baseline and 12 Months
    Title
    Percent Change From Baseline in Trochanter BMD at Month 24
    Description
    BMD at the trochanter was assessed by DXA at baseline and Month 24.
    Time Frame
    Baseline and 24 Months
    Title
    Percent Change From Baseline in Trochanter BMD at Month 12
    Description
    BMD at the trochanter was assessed by DXA at baseline and Month 12.
    Time Frame
    Baseline and 12 Months
    Title
    Percent Change From Baseline in Total Hip BMD at Month 24
    Description
    BMD at the total hip was assessed by DXA at baseline and Month 24.
    Time Frame
    Baseline and 24 Months
    Title
    Percent Change From Baseline in Total Hip BMD at Month 12
    Description
    BMD at the total hip was assessed by DXA at baseline and Month 12.
    Time Frame
    Baseline and 12 Months
    Title
    Percent Change From Baseline in Lumbar Spine BMD at Month 24
    Description
    BMD at the lumbar spine was assessed by DXA at baseline and Month 24.
    Time Frame
    Baseline and 24 Months
    Title
    Percent Change From Baseline in Lumbar Spine BMD at Month 12
    Description
    BMD at the lumbar spine was assessed by DXA at baseline and Month 12.
    Time Frame
    Baseline and 12 Months
    Title
    Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24
    Description
    BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24.
    Time Frame
    Baseline and 24 Months
    Title
    Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12
    Description
    BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12.
    Time Frame
    Baseline and 12 Months
    Title
    Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24
    Description
    s-CTx is a biochemical marker of bone resorption.
    Time Frame
    Baseline and Month 24
    Title
    Percent Change From Baseline in Log-Transformed s-CTx at Month 12
    Description
    s-CTx is a biochemical marker of bone resorption.
    Time Frame
    Baseline and Month 12
    Title
    Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24
    Description
    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
    Title
    Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12
    Description
    u-NTx/Cr is a biochemical marker of bone resorption.
    Time Frame
    Baseline and Month 12
    Title
    Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24
    Description
    Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation.
    Time Frame
    Baseline and Month 24
    Title
    Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12
    Description
    BSAP is a biochemical marker of bone formation.
    Time Frame
    Baseline and Month 12
    Title
    Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24
    Description
    Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation.
    Time Frame
    Baseline and Month 24
    Title
    Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12
    Description
    s-P1NP is a biochemical marker of bone formation.
    Time Frame
    Baseline and Month 12
    Title
    Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24
    Description
    Serum calcium is an index of calcium homeostasis.
    Time Frame
    Baseline and Month 24
    Title
    Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24
    Description
    Serum phosphate is an index of mineral homeostasis.
    Time Frame
    Baseline and Month 24
    Title
    Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24
    Description
    Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood.
    Time Frame
    Baseline and Month 24
    Title
    Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24
    Description
    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
    Title
    Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24
    Description
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    24064689
    Citation
    Bonnick S, De Villiers T, Odio A, Palacios S, Chapurlat R, DaSilva C, Scott BB, Le Bailly De Tilleghem C, Leung AT, Gurner D. Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013 Dec;98(12):4727-35. doi: 10.1210/jc.2013-2020. Epub 2013 Sep 24.
    Results Reference
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    A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)

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